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Research Project Management

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Foreword

It is with great pleasure to introduce this project entitle “Research Project management” to

contribute ideas for the enrichment of clinical research with well-being management. This

book will be an ideal tool to find a systemic approach for the management of clinical research,

and to maintain with the right path of good clinical practice and the ethical principles stated in

the Declaration of Helsinki. This book aimed to encourage all health researchers to work with

utmost professionalism and according to good clinical practice (GCP) in conducting of scientific

research.

Clinical trials involves trial subjects, their safety, rights, integrity, confidentiality and respect on

one hand and research team and how to conduct a clinical trial, planning, executing, managing

and controlling on the other hand. A combination of clinical research care with the main

principles of professional project management will justify the potential research outcome,

therapeutic value for the patient and to produce significant health care improvement.

Further, this book will explain the guidelines for conducting a clinical research which in

principles to increase the ethical awareness and improve clinical research management, in

addition to improve the quality standards. Moreover, it will promote the concept of the

clinical trials in the community and increase the number of participants as trial subjects. This

book is also could serve as a guideline for the scope of work for all health researchers to work

1
professionally according to the good clinical practice. It could be a reference textbook in all

universities with health school to show how to manage clinical research activities and to know

how to plan a clinical research in simple way. Indeed this book serves as example for applied

project management which could be used by everybody.

It is the first book ever (up to my knowledge) using the combination of both, clinical research

and professional project management, to produce a useful tool to all health researchers to do

their research in a professional way and according to the GCP standards. It is expected to be

utilize by most if not all health schools (and universities) including medical, pharmacy, nursing,

public health, epidemiology, and other. This will also embrace Food and Drug Administration

(FDA), and all drug regulatory authorities in the world which recognize practicing health

research according to GCP–ICH Harmonized tripartite guideline. Most if not all of the clinical

research organization such as SCT “Society for Clinical Trials”, SOCRA “the Society of Clinical

Research Associates”, NIH “National Institutes of Health”, ACRO “Association of Clinical

Research Organization” and many others are giving courses about GCP as “A standard for the

design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of

clinical trials” and “that provides assurance that the data and reported results are credible

and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected”.

Author
Salem Alsuwaidan
2
Research Project Management
“A clinical research with
professional project management approach”
By

Salem Alsuwaidan

3
Preface

Up to my knowledge and after a lot of research during preparation of this book, this is the first

research project using project management for professionals as a tool to manage research

activities. In this book there is a combination of project management for professional and

good clinical practice in one work to be research project manager.

The reader of this book may go to the exact terms which have been used in project

management for professional, yet it reflects a systematic account on what is happening in the

management of research. Utilization of this book is quite easy for all those who have a little

concern about research, student for any health colleges, and of course any researcher may use

it as a manual to guide for best research practices. It also can be utilize to draft policies and

procedure for any new institution would start doing research whether if it is clinical or non-

clinical research.

This book also could be used as a core material to teach how to be a research coordinator or

research assistant. The material of this book will teach all research coordinator on how to do

their work on day-to day business. Moreover, it will explain what any researcher should do to

conduct a clinical research whether if it is simple or very complicated and this research will be

conducted according to the good clinical practice. Lastly this book will unify the standard of

our research activities. This book explains the research life cycle and how is the processes to

conduct a clinical research from writing the proposal until writing a manuscript with a similar
4
process to project management this process was similar to the process of project

management.

Sequentially, a similar steps were taken for this book to conduct a clinical research project and

project management one by one. Five steps were taken to conduct any project and here it is

used five steps for research life cycle to conduct a clinical research project.

These five steps of research life cycle are:

 Initiation: that is to create a new idea and define the research project and identify the

research team including establishment of research project.

 Planning that is to establish the scope of clinical research project, define and refine the

objective, when where how to develop road map to conduct a clinical research.

 Executing that is the long step to process the methodology and to perform a good

clinical practice through conducting a good research management.

 Monitoring and controlling that is to review and track the progress of research and how

to manage changes. Then how to show the responsibility of the monitor.

 Closing that is the final step in research life cycle to show how to perform the final steps

in a clinical research and how to submit a comprehensive budget analysis report , how

5
 to submit the final report to the sponsor and a work breakdown structure on how to

write a manuscript.

Certainly, conducting of clinical research in compliance with international standards and the

guideline of good clinical practice is the greatest approach to promote clinical and research

studies in its par excellence.

Salem Alsuwaidan
Director of operation
Prince Naif Health Research Center
King Saud University, Kingdom of Saudi Arabia
[email protected]
[email protected]

6
TABEL OF CONTENT
Chapter 1. Introduction 9
Introduction 10
Related references 17
Research Life Cycle 19
Reference 24
Glossary 25
Appendices
WHO Consent Form 30
Case Report Form 36

Chapter 2. Initiation 61
Initiation 62
Financial Aspects 69
Appendices
Research Fund Application 73
Checklist for CRM Responsibility 74
Questions and Answers 75

Chapter 3. Planning 79
Planning 80
How to draft a work plan 83
Definition of goal, aim, objective and purpose 84
Identify how to process the research methodology 85
Work Breakdown Structure (WBS) 85
Consider ordering your work plan by "SMART" objectives 86
Ghant Chart 89
Draft a work plan after changes 90
Reporting system 91
List of resources 94
Write a manuscript 94
Reference 96
Questions and Answers 97
Appendices
Work Breakdown Structure for research proposal (Excel sheet) 101
Work Breakdown Structure for research proposal (Tree model) 103
Ghant Project Planner 104
7
Chapter 4. Research Methodology/ Execution 105
Research Methodology/ Execution 106
General Consideration 107
Professional Responsibility 107
Research Integration Management 108
Research Scope Management 111
Project Time Management 112
Research Project Cost Management 115
Research Quality Management 117
Project Human Resource Management 120
Research Communication Management 127
Research Risk Management 129
Research Procurement Management 131
Research Team Management 133
Reference 135
Questions and Answers 137

Chapter 5. Research Project Monitoring and Controlling 143

Research Project Monitoring and Controlling 144
Responsibility of the Monitor 147
Reference 153
Questions and Answers 154

Chapter 6. Research Project Closing 160

Research Project Closing 161
Reference 166
Appendices
Research Study Closeout 167
Research Grant Financial Report 168
Work Breakdown Structure for writing a manuscript 169

8
 Chapter 1.
Introduction
Research Project Manager

9
Introduction

The scenario of this project came from amalgamation of both good clinical practice (GCP) the

project management for professional (PMP); since all research studies and clinical trials are

considered as research project then we have to prepare and formulate a “Research Manager”

for research projects with specific job description for what are the steps to follow to get a

successful and completed clinical trials. In-fact, writing this book depends on two main

references articles namely: “A guide to the project management body of knowledge: (PMBOK

guide)” project management for professional and “Clinical Trials Requirement Guideline

(version 1.3)”, Drug sector, Saudi Food and Drug Authority, Kingdom of Saudi Arabia.

Clinical researchers may be characterized with someone who have a clinical background and is

able to apply his/her knowledge, skills, and technique to manage clinical research activities.

They are individuals who can lead the research team to complete the process of a research

project in the right direction. Compromising project management skills together with good

clinical practice will meet stakeholder needs, wants and expectation. More importantly, they

should possess the knowledge and skills to identify project management processes with

information needed to initiate, plan, execute, monitor and control and close a single research

10
project in a timely manner that will enhance the success over a wide range of research

projects.

Clinical research is systematic study on pharmaceutical products in human subjects (including

patients and other volunteers) in order to discover or verify the effects of and/or identify any

adverse reactions to investigational products, and/or to study the absorption, distribution,

metabolism and excretion of the products with the object of ascertaining their efficacy and

safety. Projects may include industries, information technology, and businesses, such as

product manufacture, transport and infrastructure, and building and construction. While

research project for clinical studies involved human subject to discover or verify the

pharmacodynamics and pharmacokinetic of a pharmaceutical product or the effect of a

medical device. Subjects involved in clinical trials may be patients or healthy people, or both.

Project management is the application of knowledge, skills, tools, and techniques to project

activities to meet the project requirements. The primary challenge of project management is

to achieve all specific goals and objectives and meet specific success criteria; while the primary

constraints are scope, time, quality and budget. Project management is accomplished through

the appropriate application includes a number of elements, which are categorized into five

process groups.

These five Process Groups are:

11
 Monitoring
Initiating Planning Executing and Closing
Controlling

There are several types of research management (RM) structures in organizations, each varying

in the degree of control and influence they have on projects within the organization, such as:

• supportive RM provide a consultative role to projects by

supplying templates, best practices, training, access to
Supportive information and lessons learned from other projects. This type of
RM serves as a project repository. The degree of control provided
by the RM is low.

• controlling RM provide support and require compliance through

various means. Compliance may involve adopting project
Controlling management frameworks or methodologies, using specific
templates, forms and tools, or conformance to governance. The
degree of control provided by the RM is moderate.

Directive • directivetake control of the projects by directly managing the

projects. The degree of control provided by the RM is high.

Project management is aimed at producing an end-product that will effect some change for

the benefit of the organization that instigated the project. It is the initiation, planning and

control of a range of tasks required to deliver this end product, which could be a physical

product, it could be new software or something less tangible like a new way of working. The

control imposed by a formal approach is essential when there are complexities such as new

technology, inter-dependent tasks, teams spread across several departments or companies, or

where teams are located in different parts of the world; all common occurrences in many
12
business projects.

A key factor that distinguishes project management from just management is that it has this

final deliverable and a finite timespan, unlike management which is an ongoing process.

Because of this, a project manager needs a wide range of skills; often technical skills, certainly

people management skills and good business awareness.

Typical components of project management are:

• Identifying requirements;

• Defining the reason why a project is necessary;

• Addressing the various needs, concerns, and expectations of the stakeholders in

planning and executing the project;

• Capturing project requirements, specifying quality of the deliverables, estimating

resources and timescales;

• Preparing a business case to justify the investment;

• Securing corporate agreement and funding;

• Developing and implementing a management plan for the project;

• Leading and motivating the project delivery team;

• Managing the risks, issues and changes on the project;

• Monitoring progress against plan;

• Managing the project budget;

13
 • Setting up, and carrying out communications among stakeholders that are active,

effective, and collaborative in nature;

• Maintaining communications with stakeholders and the project organization;

• Managing stakeholders towards meeting project requirements and creating project

deliverables;

• Balancing the competing project constraints.

• Closing the project in a controlled fashion when appropriate.

There are standard project management processes used to plan and control tasks, budgets

and schedules, to communicate between the different people involved and deal with risks.

These processes are usually ongoing throughout the project. Also, there are various phases of

a project that will have a defined start and end within the overall project lifespan. For

instance, the requirements gathering phase often occurs in the early part of the project. So a

project has a range of processes that occur throughout it life (monitoring, controlling,

communicating etc.) and a range of phases (initiation, requirements, planning etc.) that occur

roughly chronologically.

Research manager should know the strategies to manage research project and how to

facilitate relationships between the research team and others in all phases of the research

projects from writing proposal to publication. Also to know and describe every step in the

project life cycle in depth, so the research project manager will know exactly which tasks to

14
complete, when and how. Whether they are experts or novices, it helps to complete tasks

faster than before.

Research Project Managers should have overall understanding of all aspects of clinical

research and how is the research team familiar to their jobs. This understanding helps

sponsors and funding agencies to communicate seamlessly with the clinical researchers and

project team members to ensure that project objectives, work plans, and priorities are met.

Effective project managers require a balance of ethical, interpersonal, and conceptual skills

that help them analyze situations and interact appropriately. Also requires important

interpersonal skills, such as:

Leadership
Team
Coaching
building

Conflict
Management
Motivation

Interpersonal
Trust
Skills
Communication
building

Negotiation Influence

Political
and Decision
Cultural Making
awareness

15
The ability of a Clinical Research Project Manager (CRM) to manage all aspects of a clinical trial

significantly impacts the time and cost taken to develop a drug or medical device. It is

important that a Research Project Manager is a well-rounded individual. These CRMs will be

required to have a high set of skills, tools and knowledge that is proficient in clinical research.

This allows research project management to efficiently lead the trial outcome from the start of

the project. A Project Manager must also have the ability to appropriately act, respond and

adapt to developing situations during a clinical trial. The project manager is the person

assigned by the performing organization to lead the team that is responsible for achieving the

project objectives.

Feasibility assessments for a research study is likely to be with potential benefit. That is if the

investigator achieve the goals of the clinical study represent a common sense that will be

converted in sharing the development and innovation. The second choice that if the

investigator identify possible problems in the worst case scenarios that will be another

achievement to keep away from this treatment. The feasibility assessment focuses on the

degree significant of the clinical research technically, within the budget, and on the planned

time frame.

16
References
1. Clinical research associate: Job description | Prospects.ac.uk. Available at
www.prospects.ac.uk/clinical_research_associate_job_description.htm

2. Basic Skills for Project Managers.

catalogue.pearsoned.co.uk/samplechapter/0130219142.pdf

3. U.S. Food and Drug Administration. Clinical Trials and Human Subject Protection
www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ May 28, 2015 - Good
Clinical Practice in FDA-Regulated Clinical Trials.

4. Clinical Trials administration

https://www.sfda.gov.sa/en/drug/Clinical_Trials/Pages/default.aspx

5. www.nhlbi.nih.gov › Clinical Trials

6. WHO | Clinical trials. www.who.int/topics/clinical_trials/en

7. Clinical trials and medical research - Definition - NHS Choices

www.nhs.uk/Conditions/Clinical-trials/Pages/Definition.aspx

8. 10 Minute Guide to Project Management

9. The one-minute project manager. Frank Greenwood, PMP

10.A guide to the project management body of knowledge: (PMBOK guide) – Fifth edition
2013. Project management Institution, Inc. 14 Campus Boulevard, Newtown Square,
Pennsylvania 19073-3299 USA.

11.A project managers guide to successful projects. Brent W. Knapp, PMP. Aligned with
PMBOK Guide Sturgeon Publishing 2005.

12.Practice Standard for Work Breakdown Structures 2nd ed. 2006. Project management
Institution, Inc. 4 Campus Boulevard, Newtown Square, Pennsylvania 19073-3299 USA.

13.Points to consider when assessing the feasibility of research. The Association of Medical
Research Charities (AMRC) and NIHR Medicines for Children Research Network

17
14.who.int/rpc/research_ethics/informed_consent/

15.A Project Management Primer or “a guide on how to make projects work”. Nick Jenkins,
2005.

18
RESEARCH LIFE CYCLE

This book is offering an archive containing a combination materials of good clinical practice or

clinical trials requirement and project managers for professional. Most if not all previous work

related to research project management have breakdown their work to small divisions or

stages. For a typical research proposal, the stages include development of the research

proposal; its peer-review; carrying out of the experiment; and processing, analysis and

interpretation of the data which is eventually reported and published in various forms as

research outputs. In addition to these familiar phases, we have incorporated several idealized

stages to cater for the long-term management and availability of scientific data; these include

appraisal and quality control; documentation including metadata and contextual information;

storage, archive, preservation and curation; and IPR, embargo and access control [1].

There is no specific definition for research life cycle, but I don’t agree with “Research data

management covers all phases of the research lifecycle” because research data management

does not include research operation where budget, procurement and logistics and human

resource play a major part in research life cycle [2, 3]. Most of the universities and research

institutions have similar approach (more or less) for the steps of life cycle such as:

1. Initial concept

2. Proposal Planning & Writing

19
  Review of existing data sources, determine if project will produce new data or

combine existing data.

 Investigate archiving challenges, costs, consent and confidentiality

 Identify potential users of your data

 Contact Archives for advice

3. Project Start Up

 Create a data management plan

 Make decisions about documentation form and content

 Conduct pretest of collection materials and methods

4. Data Collection

 Organize files, backups & storage, QA for data collection

5. Think about access control and security

6. Data Analysis

 Document analysis and file manipulations

 Manage file versions

7. Data Sharing

 Determine file formats

 Contact Archive for advice

 Further document and clean data

20
 8. End of Project

9. Deposit data in data archive (repository)

Research life cycle is a model trying to explain individuals on how is the research project to be

conducted. The research life-cycle implies the steps of whole clinical trial or research study,

and to search for what are the keys to manage this research. Project management is the how

to carefully project or plan, organize, motivate and control resources to achieve specific goals

and meet specific success criteria [4].

Clinical project management is to achieve all of the project aims and objectives and to find

alternative plan for constrains and obstacles [5]. This objective is similar to research project

manager.

Research life cycle is an overall meaning for the preparing the initial concepts, planning,

research methodologies and analysis until closing. The appropriate application and integration

of a research project management processes are categorized into five Process Groups.

These five Process Groups may called steps of research cycle identified as:

21
Initiation: Those processes performed to define a new research project or a
new phase of an existing clinical trial or project by obtaining authorization to
start the project or phase.

• Define as writing a research proposal for a new idea provides a detailed

description to meet the standards.
• Ensure the commitment of the sponsor, IRB concerns, and/or Good
Clinical Practice standards.
• Ensure the submission of all essential documents for the conduct of a
clinical trial.
• Identify research team.

Planning: Those processes required to establish the scope of the research

project, refine the purpose and objectives, and define the course of action
required to attain the aim and the objectives that the project was
undertaken to achieve.

• Define and provide details on a scientific research methodology and deals

specifically with the manner in which data is collected, analyzed and
interpreted.
• Ensure all equipment and supplies availability.
• Ensure that the site of conducting the clinical research is appropriate.
• Create work break down structure.
• Assign duties for the research team.

22
Executing: Those processes performed to complete the work defined in the
project management plan to satisfy the project specifications.

• Perform the research methodology as plan to produce results according to the

GCP and international standards.
• Coordinate and integrate.
• This phase is to ensure that the research methodology is executed according
to the plan. Executing phase involves proper co-ordination and management
of human resources, equipment, supplies and any other resources such as
material and budgets. Moreover, this phase will include data collection,
organize files, backups & storage, data analysis and file manipulations. It is
consider the longest phase and the most productive phase.

Monitoring and Controlling: Those processes required to track, review, and

regulate the progress and performance of the project; identify any areas in which
changes to the plan are required; and initiate the corresponding changes.
• Identify variance to the planned methodology.
• Identify changes (if any).
• Identify the corrective or preventive actions.
• Initiate the corresponding changes.

Closing: Those processes performed to finalize all research activities across

all process groups formally close the research project.

• Conclude all results in a discussion format.

• Complete the project as a conclusion.
• Complete the final touches of the budget processing and close it.
• Submit for publication.

23
References:
1. I2S2 Idealised Scientific Research Activity Lifecycle Model; www.ukoln.ac.uk/.../I2S2-
ResearchActivityLifecycleModel-110407.

2. Research Lifecycle - Guides at University of Western Australia. guides.is.uwa.edu.au/

3. Steps in the Data Life Cycle. University of Virginia Library.

data.library.virginia.edu › Research Data Services › Data Management

4. What is Project Management? | Project Management Institute". Pmi.org.

Retrieved 2014-06-04.

5. Project Management. McGraw-Hill Professional, 2006. Lewis R. Ireland (2006)

24
Glossary
Project: a Project is a temporary endeavor design undertaken to create a unique product,
service or result. Temporary means having a definite beginning and end (usually time-
constrained, and often constrained by funding or deliverables) undertaken to meet unique
goals and objectives. The end is reached when the project’s objectives have been achieved, or
if the project is terminated for any reason.
Project Manager Operational Manager
Role ends with project Routine
Temporary team Stable organization
Many different skills Specialist skills
Work not done before Work repeatable
Time, cost and scope constraints Annual planning cycle
Unique goals and objectives Multiple purposes
Difficult to estimate time and budget Budgets set and fixed events
Protects the deliverables (time, cost, Protects the Service (capacity, budget,
Quality) availability
Tasks are specific for that for that project Tasks are repetitive, routine and cyclical
and have never been done before
Implement revolutionary change Implement evolutionary change
Teams are formed to implement projects Teams are consistent
and then disbanded once the project is
completed
Teams consist of team members from Teams frequently consist of team members
different departments , different skill sets with similar technical skill sets
Examples: Example:
- A university hospital designs and
constructs a new clinic (s). - Caring for patients at the
- A diabetic structured self- bedside in a hospital or
management program using prolongation of hospital stay.
monitoring devices that - Day to day follow-up activities
electronically send blood sugar that a physician and his/her
level and blood pressure directly patients engage in on a daily
to physician. In the beginning it basis for the purposes of
is a project after implementing providing a good care.
the program it will be an - Ongoing research
operation because it will be a
routine activity.
- Clinical Trials

25
Operation: An ongoing work effort is generally a repetitive process because it follows an
organization’s existing procedures. The ongoing execution of activities that produce the same
result or product repetitively is what operations is all about.
Operations are permanent initiatives that produce repetitive results, with resources assigned
to do the same set of tasks and produce a standard output. In the life of a product, there will
be many projects to improve the product, add new features etc. and these projects will come
and go as required. The underlying production of the product will continue as usual, although
there will be refinements done and included in the product over the period.
Projects require project management, while operations require business process management
or operations management. Projects and Operations will interact with each other at key points
in a product’s life cycle.

Research Team: is one or a group of workers that have the impact to execute the
methodology according to the instruction of the PI. This team constructed from (PI+ co-PI +
sub-PI).
Research consulting Team: Consultants individual that have the ability to provide a
consultation to a research project such Biostatistician, Epidemiologist, consultant or professor
from the same field.
Research support team: is one or a group of coworkers that have the impact to execute the
methodology according to the instruction of the research team such as Technologists, Nurses
phlebotomists, etc.
Sponsor: A sponsor is the person or organization who provides financial resources and support
for the research project and is accountable for enabling success. The sponsor may be external
or internal, individual or group, government or private sector, to the project manager’s
organization.

Research Project Manager also known as clinical research project manager (CRM): The
research project manager is the person assigned by the organization to lead the team that is
responsible for achieving the research objectives. CRM is reporting to the principle
investigator while the research is conducting and after completing the clinical research will
report to the research organization. CRM has responsibilities for over-seeing all aspects of the
day-today activities in pursuit of a project, including coordinating staff, allocating resources,
managing the budget, and coordinating overall efforts to achieve a specific, desired result.

26
Research Technician: To perform and report a variety of laboratory procedures as assigned
and as needed for research and diagnostics.

Research Coordinator: To coordinate and facilitate various assigned clinical research projects
to ensure its compliance of the institutional policies and procedures according to GCP and the
international standards.

Main investigator (MI): is the scientific leader for a multi-center research project, should have
the main responsibility to select the research center, principle investigator(s), in a multi-center
study in addition to all aspects concerning a clinical research project.
Principle investigator (PI): is the lead scientist for a particular well-defined research project,
such as a laboratory study or clinical trial.
Co-Principle Investigator (Co-PI): is the person who takes direct responsibility next to the PI
for completion of a research project.
Sub-investigators: one or a group of scientists working together to complete a research
project under the leadership of the PI.
Clinical Trial (CT): is a prospective biomedical, pharmaceutical or behavioral research studies
on human subjects that is designed to answer specific questions about biomedical,
pharmaceutical or behavioral interventions and to discover or verify the effects of these
products on a volunteer subjects or patients.
Contract Research Organization (CRO): is the business partners are external organizations
provide specialized expertise regarding the CT agreement that have a special relationship with
the enterprise.
Saudi Food and Drug Authority (SFDA): is to regulate, oversee, and control food, drug,
medical devices, as well as to set mandatory standard specifications thereof, whether they are
imported or locally manufactured. The control and/or testing activities can be conducted in
the SFDA or other agency's laboratories. SFDA what we used to call Saudi regulatory
authority.
Institutional Review Board (IRB), also known as an independent ethics committee (IEC),
ethical review board (ERB) or research ethics board (REB), is a committee that has been
formally designated to approve, monitor, and review CT involving humans. Three main
concerns for the IRB, Ethical concepts, scientific merits, and applicability.

27
Good Clinical Practice (GCP), is an international ethical and scientific quality standard for
designing, conducting, recording and reporting trials that involve the participation of human
subjects. A standard for clinical studies which encompasses the design, conduct, monitoring,
termination, audit, analyses, reporting and documentation of the studies and which ensures
that the studies are scientifically and ethically sound and that the clinical properties of the
pharmaceutical product (diagnostic, therapeutic or prophylactic) under investigation are
properly documented. It is also a standard for clinical trials that provides assurance that the
data and reported results are credible and accurate, and that the rights, integrity, and
confidentiality of trial subjects are protected.

Standard Operating Procedures (SOP): To provide a general framework enabling the efficient
implementation and performance of all the functions and activities for a particular trial as
described in this document.
Informed consent: is a process for where the PI should obtain permission before conducting a
healthcare intervention on a human subject. Informed consent is collected according to
guidelines and standards of the GCP where the investigator should have the IRB written
approval of the written informed consent form and any other written information to be
provided to subjects. In cases where the subject is considered unable to give informed consent,
another person is generally authorized to give consent on his behalf, e.g., parents or legal
guardians of a child (the child may be required to provide informed assent). Informed Consent
Form (example from WHO is attached) has two parts:
 Information Sheet (to share information about the research with you)
 Certificate of Consent (for signatures if you agree to take part)

Case Report Form (CRF): A printed, optical, or electronic document designed to record all of
the protocol required information specifically used in clinical research to be reported to the
sponsor on each trial subject. The sponsor is responsible for designing a CRF that accurately
represents the protocol of the clinical trial, as well as managing its production, monitoring the
data collection and auditing the content of the filled-in CRFs. There is no specific size for a CRF
so that it can range from a handwritten one-time 'snapshot' for one participant in the clinical
trial to hundreds of pages. CRFs can be electronically captured data obtained over a period of
weeks or months. It can also include required check-up visits months after the patient's
treatment has stopped. (Example attached).
Work Breakdown Structure (WBS): It is a tree structural view that shows a subdivision or
breaking elements to a deliverable-oriented decomposition of a project into smaller
components. It is an essential tool for planning and executing the project. A work breakdown
structure is a key project deliverable that organizes the team's work into manageable sections.
28
The work breakdown structure can be displayed in two forms one in form of a table with
subdivision of tasks two in form of an organizational chart. (Examples attached).
Ghant Chart: It is a diagram to illustrate the start and finish dates of the terminal elements.
This diagram shows the process of analyzing research activity sequences, durations, and
resource requirements. It summarize the relationship of planning and work breakdown
structure (duration and responsibilities) of the research project. (Example attached).
Goal, Aim, Objective and Purpose by Merriam-Webster
Goal: something has been achieved or to achieve the terminal point, the end toward which
effort is directed.

Aim: something achievable that you hope to achieve (so it is an attempt to direct to a target).
Objective: something that you plan to achieve, expressing or dealing with facts or conditions
as perceived without distortion by personal feelings, prejudices, or interpretations.
Purpose: the aim that someone wants to achieve, or that something is intended to achieve.

29
 Research Ethics Review Committee

Informed Consent

(Language used throughout form should be at the level of a local student of class 6th/8th)

PART I: Information Sheet

Introduction
Briefly state who you are and explain that you are inviting them to participate in the research you are doing.
Inform them that they may talk to anyone they feel comfortable talking with about the research and that they
can take time to reflect on whether they want to participate or not. Assure the participant that if they do not
understand some of the words or concepts, that you will take time to explain them as you go along and that
they can ask questions now or later.

Purpose of the research

Explain in lay terms why you are doing the research. The language used should clarify rather than confuse. Use
local and simplified terms for a disease, e.g. local name of disease instead of malaria, mosquito instead of
anopheles, “mosquitoes help in spreading the disease” rather than “mosquitoes are the vectors”. Avoid using
terms like pathogenesis, indicators, determinants, equitable etc. There are guides on the internet to help you
find substitutes for words which are overly scientific or are professional jargon.

Type of Research Intervention

Briefly state the type of intervention that will be undertaken. This will be expanded upon in the procedures
section but it may be helpful and less confusing to the participant if they know from the very beginning whether,
for example, the research involves a vaccine, an interview, a biopsy or a series of finger pricks.

Participant selection
State why this participant has been chosen for this research. People often wonder why they have been chosen
to participate and may be fearful, confused or concerned.

Voluntary Participation
Indicate clearly that they can choose to participate or not. State, what the alternative - in terms of the treatment
offered by the clinic - will be, if they decide not to participate. State, only if it is applicable, that they will still
receive all the services they usually do whether they choose to participate or not. This can be repeated and
expanded upon later in the form as well, but it is important to state clearly at the beginning of the form that
participation is voluntary so that the other information can be heard in this context.

Information on the Trial Drug [Name of Drug]

1) give the phase of the trial and explain what that means. Explain to the participant why you are comparing or
testing the drugs.

30
2) provide as much information as is appropriate and understandable about the drug such as its manufacturer
or location of manufacture and the reason for its development.
3) explain the known experience with this drug
4) explain comprehensively all the known side-effects/toxicity of this drug, as well as the adverse effects of all
the other medicines that are being used in the trial

Procedures and Protocol

Describe or explain the exact procedures that will be followed on a step-by-step basis, the tests that will be
done, and any drugs that will be given. Explain from the outset what some of the more unfamiliar procedures
involve (placebo, randomization, biopsy, etc.) Indicate which procedure is routine and which is experimental
or research.Participants should know what to expect and what is expected of them. Use active, rather than
conditional, language. Write "we will ask you to…." instead of "we would like to ask you to….".

In this template, this section has been divided into two: firstly, an explanation of unfamiliar procedures and,
secondly, a description of process.

A. Unfamiliar Procedures
This section should be included if there may be procedures which are not familiar to the participant.

If the protocol is for a clinical trial:

1) Involving randomization or blinding, the participants should be told what that means and what chance they
have of getting which drug (i.e. one in four chances of getting the test drug).
2) Involving an inactive drug or placebo, it is important to ensure that the participants understand what is meant
by a placebo or inactive drug.
3) Which may necessitate a rescue medicine, then provide information about the rescue medicine or treatment
such as what it is and the criterion for its use. For example, in pain trials, if the test drug does not control pain,
then intravenous morphine may be used as a rescue medicine.

If the protocol is for clinical research:

Firstly, explain that there are standards/guidelines that will be followed for the treatment of their condition.
Secondly, if as part of the research a biopsy will be taken, then explain whether it will be under local anesthesia,
sedation or general anesthesia, and what sort of symptoms and side effects the participant should expect under
each category.

For any clinical study (if relevant):

If blood samples are to be taken explain how many times and how much in a language that the person
understands. It may, for example, be inappropriate to tell a tribal villager that blood equal to a wine-glass full
will be taken but it may be very appropriate to use pictures or other props to illustrate the procedure if it is
unfamiliar.

If the samples are to be used only for this research, then explicitly mention here that the biological samples
obtained during this research procedure will be used only for this research, and will be destroyed after (3) years,
when the research is completed. If the tissues/blood samples or any other human biological material will be
stored for a duration longer than the research purpose, or is likely to be used for a purpose other than

31
mentioned in the research proposal, then provide information about this and obtain consent specifically for
such storage and use in addition to consent for participation in the study - (see last section)

B. Description of the Process

Describe to the participant what will happen on a step-by-step basis. It may be helpful to the participant if you
use drawings or props to better illustrate the procedures. A small vial or container with a little water in it is one
way of showing how much blood will be withdrawn.

Duration
Include a statement about the time commitments of the research for the participant including both the duration
of the research and follow-up, if relevant.

Side Effects
Potential participants should be told if there are any known or anticipated side effects and what will happen in
the event of a side effect or an unexpected event.

Risks
Explain and describe any possible or anticipated risks. Describe the level of care that will be available in the
event that harm does occur, who will provide it, and who will pay for it. A risk can be thought of as being the
possibility that harm may occur. Provide enough information about the risks that the participant can make an
informed decision.

Benefits
Mention only those activities that will be actual benefits and not those to which they are entitled regardless of
participation. Benefits may be divided into benefits to the individual, benefits to the community in which the
individual resides, and benefits to society as a whole as a result of finding an answer to the research question.

Reimbursements
State clearly what you will provide the participants with as a result of their participation. WHO does not
encourage incentives. However, it recommends that reimbursements for expenses incurred as a result of
participation in the research be provided. These may include, for example, travel costs and money for wages
lost due to visits to health facilities. The amount should be determined within the host country context.

Confidentiality
Explain how the research team will maintain the confidentiality of data, especially with respect to the
information about the participant which would otherwise be known only to the physician but would now be
available to the entire research team. Note that because something out of the ordinary is being done through
research, any individual taking part in the research is likely to be more easily identified by members of the
community and is therefore more likely to be stigmatized.

32
Sharing the Results
Where it is relevant, your plan for sharing the information with the participants should be provided. If you have
a plan and a timeline for the sharing of information, include the details. You should also inform the participant
that the research findings will be shared more broadly, for example, through publications and conferences.

Right to Refuse or Withdraw

This is a reconfirmation that participation is voluntary and includes the right to withdraw. Tailor this section to
ensure that it fits for the group for whom you are seeking consent. The example used here is for a patient at a
clinic.

Alternatives to Participating
Include this section only if the study involves administration of investigational drugs or use of new therapeutic
procedures. It is important to explain and describe the established standard treatment.

Who to Contact
Provide the name and contact information of someone who is involved, informed and accessible (a local person
who can actually be contacted. State also that the proposal has been approved and how.

This proposal has been reviewed and approved by [name of the local IRB], which is a committee whose task
it is to make sure that research participants are protected from harm. If you wish to find about more about
the IRB, contact [name, address, telephone number.]). It has also been reviewed by the Ethics Review
Committee of the World Health Organization (WHO), which is funding/sponsoring/supporting the study.

33
PART II: Certificate of Consent
This section should be written in the first person and have a statement similar to the one in bold below. If the
participant is illiterate but gives oral consent, a witness must sign. A researcher or the person going over the
informed consent must sign each consent. The certificate of consent should avoid statements that have "I
understand…." phrases. The understanding should perhaps be better tested through targeted questions during
the reading of the information sheet (some examples of questions are given above), or through the questions
being asked at the end of the reading of the information sheet, if the potential participant is reading the
information sheet him/herself.

I have read the foregoing information, or it has been read to me. I have had the opportunity to ask questions
about it and any questions that I have asked have been answered to my satisfaction. I consent voluntarily to
participate as a participant in this research.

Print Name of Participant__________________

Signature of Participant ___________________
Date ___________________________
Day/month/year

If illiterate
A literate witness must sign (if possible, this person should be selected by the participant and should have no
connection to the research team). Participants who are illiterate should include their thumb-print as well.

I have witnessed the accurate reading of the consent form to the potential participant, and the individual has
had the opportunity to ask questions. I confirm that the individual has given consent freely.

Print name of witness_____________________ AND Thumb print of participant

Signature of witness ______________________
Date ________________________
Day/month/year

Statement by the researcher/person taking consent

I have accurately read out the information sheet to the potential participant, and to the best of my ability
made sure that the participant understands that the following will be done:
1.
2.
3.
I confirm that the participant was given an opportunity to ask questions about the study, and all the questions
asked by the participant have been answered correctly and to the best of my ability. I confirm that the
individual has not been coerced into giving consent, and the consent has been given freely and voluntarily.

34
A copy of this ICF has been provided to the participant.

Print Name of Researcher/person taking the consent________________________

Signature of Researcher /person taking the consent__________________________
Date ___________________________
Day/month/year

35
 CASE REPORT FORM

Short Title/Acronym

Main (chief) Investigator:

Principle investigator (if different):

Protocol Number:

Name of site:

Site number:

Subject Number:

Subject Initials:

36
 Centre (Site) No. Subject No.
Screening No. Patient Initials

SUBJECT ELIGIBILITY

INCLUSION CRITERIA
Participants should meet the following criteria and MUST be answered YES for
participant to be included in the trial. (Yes or No) Yes No
1
2
If any of the above criteria is answered NO, the participant is NOT eligible for the trial and must not be included in the study.
Please list reason(s) for ineligibility for screen failure on Participant Eligibility Review page.

EXCLUSION CRITERIA

The following criteria will exclude potential subjects from the study or MUST be
answered NO for the participant to be included in the trial. (Yes or No) Yes No
1
2
If any of the above criteria is answered YES, the participant is NOT eligible for the trial and must not be included in the study.
Please list reason(s) for ineligibility for screen failure on Participant Eligibility Review page.

Date the Subject Signed the Informed Consent Form: ____/_____/______

DD/M M/YYYY

Did the subject meet all of the inclusion/exclusion criteria? Yes No

INFORMATION SESSION
Date of Information Session
Did the subject attend the Information Session? Yes No
Comments (if any):

Completed by (Name): Signature Date:

37
 Centre (Site) No. Subject No.
Screening No. Patient Initials

VISIT 1 (SCREENING) demographic data

Date of Assessment: __ __ / __ __ __ / __ __ __ __
(DD / M M / YYYY)

Informed Consent:

Date participant/relative signed written __ __ / __ __ __ / __ __ __ __

consent form: (DD / MMM / YYYY)

Name of person taking informed consent: __________________________________________

Date of Birth: __ __ / __ __ __ / __ __ __ __
(DD / MMM / YYYY)

Sex: Male Female

Height: (cm) Weight: (Kg)

Ethnicity: Level of Education:

White Illiterate
Mixed race Primary
Asian Secondary
Black Graduate
Hispanics Highly graduate
Other ethnicity Other:

Completed by (Name): Signature Date:

38
 Centre (Site) No. Subject No.
Screening No. Patient Initials

VISIT 1 (SCREENING) Medical History

Date of Assessment: __ __ / __ __ __ / __ __ __ __
(DD / M M / YYYY)

Has the patient had any relevant medical history? Yes No

Condition / illness /surgical procedure Start Date Stop Date

Completed by (Name): Signature Date:

39
 Centre (Site) No. Subject No.
Screening No. Patient Initials

VISIT 1 (SCREENING) Physical Exam

Date of Assessment: __ __ / __ __ __ / __ __ __ __
(DD / M M / YYYY)

Not Comment
System Abnormal Normal
done (if abnormal)
General Appearance

Skin
Eyes, Ears, Nose &
Throat
Head, Neck & Thyroid

Cardiovascular

Respiratory

Abdomen

Extremities

Genitalia

Anorectal

Lymph Nodes

Muscular-Skeletal

Neurological
Others (please
specify)

Completed by (Name): Signature Date:

40
 Centre (Site) No. Subject No.
Screening No. Patient Initials

VISIT 1 (SCREENING) Vital Signs and ECG

Date of Assessment: __ __ / __ __ __ / __ __ __ __
(DD / M M / YYYY)

Parameter Unit Result

Systolic Blood mmHg
Pressure
Diastolic Blood mmHg
Pressure
Heart Rate beats/mi
nute
Respiratory Rate breaths/
minute
Body Temperature ºC

Weight Kg

Date & Time of ECG: __ __ / __ __ __ / __ __ __ __ ________:_______

(DD / M M / YYYY) HH:MM

Within normal limits

The ECG is:
Abnormal, NOT clinically significant

Abnormal, clinically significant, please specify:

________________________________________________________

Completed by (Name): Signature Date:

41
 Centre (Site) No. Subject No.
Screening No. Patient Initials

VISIT 1 (SCREENING) Hematology

Date of Assessment: __ __ / __ __ __ / __ __ __ __
(DD / M M / YYYY)

Date & Time of Collecting Sample: __ __ / __ __ __ / __ __ __ _ ______:_______

(DD / M M / YYYY) HH:MM
HAEMATOLOGY Value Unit Comment for abnormal range
Laboratory Parameter
WBC

RBC

Hb

HCT

MCV

MCH

PLT

NEUTROPHILS

LYMPHOCYTES

MONOCYTES

EOSINOPHILS

BASOPHILS

RETICULOCYTES

Completed by (Name): Signature Date:

42
 Centre (Site) No. Subject No.
Screening No. Patient Initials

VISIT 1 (SCREENING) Biochemistry

Date of Assessment: __ __ / __ __ __ / __ __ __ __
(DD / M M / YYYY)

Date & Time of Collecting Sample: __ __ / __ __ __ / __ __ __ _ ______:_______

(DD / M M / YYYY) HH:MM
BIOCHEMISTRY Value Unit Comment for abnormal reange
Laboratory Parameter
SODIUM

POTASSIUM

CHLORIDE

BICARBONATE

UREA

CREATININE

TOTAL PROTEIN

TOTAL BILIRUBIN

ALBUMIN

ALK PHOS

ALT

AST

CALCIUM

Completed by (Name): Signature Date:

43
 Centre (Site) No. Subject No.
Screening No. Patient Initials

VISIT 1 (SCREENING) Other

Date of Assessment: __ __ / __ __ __ / __ __ __ __
(DD / M M / YYYY)

SPECIFIC LABORATORY TEST

URINE PREGNANCY TEST
URINE DRUG SCREEN
ORAL HEALTH EXAMINATION
BEHAVIORAL COUNSELING

Clinical <insert assessment> Laboratory tests No Yes,

performed?
Comment *: __________________

__ __ / __ __ __ / __ __ __ __
Date of Sample:
(DD / MMM / YYYY)
________:_______
Time of Sample
HH:MM

No Yes, Complete below

Was laboratory sample taken at different
Laboratory name / Location:
hospital to <insert investigator’s site lab
name>? _______________________________________
___

Completed by (Name): Signature Date:

44
 Centre (Site) No. Subject No.
Screening No. Patient Initials

VISIT 1 (SCREENING) Screening Concomitant Medications

Date of Assessment: __ __ / __ __ __ / __ __ __ __
(DD / M M / YYYY)

Medication Dose Freq

Reason for Start Date Stop Date
(Generic or and uenc
use Route (DD/MMM/YYYY) (DD//MMM/YYY)
trade name) units y

1. ____/_____/_____ ____/_____/_____

2. ____/_____/_____ ____/_____/_____

3. ____/_____/_____ ____/_____/_____

4.
____/_____/_____ ____/_____/_____

5. ____/_____/_____ ____/_____/_____

6.
____/_____/_____ ____/_____/_____

7. ____/_____/_____ ____/_____/_____

8.
____/_____/_____ ____/_____/_____

9. ____/_____/_____ ____/_____/_____

10.
____/_____/_____ ____/_____/_____

Completed by (Name): Signature Date:

45
 Centre (Site) No. Subject No.
Screening No. Patient Initials

VISIT 1 (SCREENING) Smoking / Alcohol Status

Date of Assessment: __ __ / __ __ __ / __ __ __ __
(DD / M M / YYYY)

Has the participant ever smoked? No Yes, Complete below

Participant’s average daily use:

- Number of cigarettes : ___ ___
- Number of cigars : ____ ___
Current Smoker
- Number of pipes : ___ ___

Smoked for ___ ___ months/years

Smoked for ___ ___ months/years

Date when smoking ceased: __ __ / __ __ __ / __ __ __ __

(DD / MMM / YYYY)

Former smoker When smoking, participant’s average daily use:

- Number of cigarettes : ___ ___
- Number of cigars : ____ ___
- Number of pipes : ___ ___

Participant’s alcohol consumption

Participant’s average consumption per:

- Number of units of wine : ___ ___
- Number of units of beer : ____ ___
- Number of units of spirits : ___ ___
(unit = drinkable cup of the above)

Completed by (Name): Signature Date:

46
 Centre (Site) No. Subject No.
Screening No. Patient Initials

VISIT 1 (SCREENING) PRINICIPAL INVESTIGATOR’S SIGN OFF

Date of Assessment: __ __ / __ __ __ / __ __ __ __
(DD / M M / YYYY)

Principal Investigator’s Signature Statement:

I have reviewed this CRF and confirm that, to the best of my knowledge, it accurately reflects the study
information obtained for this participant for visit#1. All entries were made either by me or by a person under
my supervision who has signed the Delegation and Signature Log.

Principal Investigator’s Signature:

__________________________________

Principal Investigator’s Name: __ __/ __ __ __ / __ __ __ __

Date of Signature:
(DD / MMM / YYYY)
________________________________________

ONCE SIGNED, NO FURTHER CHANGES CAN BE MADE TO THIS PART OF CRF WITHOUT A
SIGNED DATA QUERY FORM.

RANDOMIZATION / ENROLMENT

Participant study Number allocated: ____ ____ ____

__ __ / __ __ __ / __ __ __ __
Date of Randomisation/Enrolment:
(DD / MMM / YYYY)

Completed by (Name): Signature Date:

47
 Centre (Site) No. Subject No.
Screening No. Patient Initials

VISIT X <INSERT VISIT NAME> CHECKLIST

Date of Assessment: __ __ / __ __ __ / __ __ __ __
(DD / M M / YYYY)

Visit Checklist:

Yes No

Have there been any new Adverse Events?

1.
(If yes, please record in Adverse Events page)

Have there been any changes in Concomitant Medications?

2.
(If yes, please record in Concomitant Medications Log)

Add further assessments required at each visit, amend the following pages to fit your
3.
requirements

4.

Completed by (Name): Signature Date:

48
 Centre (Site) No. Subject No.
Screening No. Patient Initials

VISIT X <INSERT VISIT NAME> PHYSICAL EXAM

Date of Assessment: __ __ / __ __ __ / __ __ __ __
(DD / M M / YYYY)

System Changed

Not Not Brief description and comment if clinically significant

General Appearance
Changed done or not. Consider if it is an AE and add to log.

Skin

Eyes, Ears, Nose &

Throat

Head, Neck & Thyroid

Cardiovascular

Respiratory

Abdomen

Extremities

Genitalia

Anorectal

Lymph Nodes

Muscular-Skeletal

Neurological

Others (please specify)

Completed by (Name): Signature Date:

49
 Centre (Site) No. Subject No.
Screening No. Patient Initials

VISIT X <INSERT VISIT NAME> VITAL SIGNS & ECG

Date of Assessment: __ __ / __ __ __ / __ __ __ __
(DD / M M / YYYY)

No (Comment Below) Yes, Complete below

Were Vital Signs performed?
Comment* _____________________________
__ __ / __ __ __ / __ __ __ __ ________:_______
Date & Time of Vital Signs: (DD / MMM / YYYY)
HH:MM

Blood Pressure supine/standing/seating : ___ ___ ___ / ___ ___ ___ mmHg

Pulse: ____ ___ ___ beats/min

Weight: ___ ___ ___ . ___ kg Height: ___ . ___ ___ m

Oral/Tympanic Temperature: ___ ___ . ___ °C

No (Comment Below) Yes, Complete below

Was an ECG performed?
Comment*:_______________________________

__ __ / __ __ __ / __ __ __ __ ________:_______
Date & Time of ECG: (DD / MMM / YYYY)
HH:MM

Within normal limits

Abnormal, NOT clinically significant

The ECG is:
Abnormal, clinically significant, please specify:

_____________________________________________________________

Completed by (Name): Signature Date:

50
 Centre (Site) No. Subject No.
Screening No. Patient Initials
VISIT X <INSERT VISIT NAME> VITAL SIGNS & ECG
Date of Assessment: __ __ / __ __ __ / __ __ __ __
(DD / M M / YYYY)

Date & Time of Sample: __ __ / __ __ __ / __ __ __ __ ________:_______

(DD / MMM / YYYY) HH:MM
No Yes, Complete below
Was laboratory sample taken at different hospital to
Laboratory name / Location:
<insert investigator’s site lab name>?
__________________________________________
Value
HAEMATOLOGY
Laboratory Parameter

HAEMATOLOGY Value Unit Comment for abnormal range

Laboratory Parameter
WBC No Yes

RBC No Yes

Hb No Yes

HCT No Yes

MCV No Yes

MCH No Yes

PLT No Yes

NEUTROPHILS No Yes

LYMPHOCYTES No Yes

MONOCYTES No Yes

EOSINOPHILS No Yes

BASOPHILS No Yes

RETICULOCYTES No Yes

Completed by (Name): Signature Date:

51
 Centre (Site) No. Subject No.
Screening No. Patient Initials

VISIT X <INSERT VISIT NAME> BIOCHEMISTRY

Date of Assessment: __ __ / __ __ __ / __ __ __ __
(DD / M M / YYYY)

Date & Time of Sample: __ __ / __ __ __ / __ __ __ __ ________:_______

DD / MMM / YYYY) HH:MM

No Yes, Complete below

Was laboratory sample taken at different hospital to
Laboratory name / Location:
<insert investigator’s site lab name>?
__________________________________________

BIOCHEMISTRY Value Unit Comment for abnormal range

Laboratory Parameter
SODIUM No Yes

POTASSIUM No Yes

CHLORIDE No Yes

BICARBONATE No Yes

UREA No Yes

CREATININE No Yes

TOTAL PROTEIN No Yes

TOTAL BILIRUBIN No Yes

ALBUMIN No Yes

ALK PHOS No Yes

ALT No Yes

AST No Yes

CALCIUM No Yes

Completed by (Name): Signature Date:

52
 Centre (Site) No. Subject No.
Screening No. Patient Initials

VISIT X <INSERT VISIT NAME> Other BIOCHEMISTRY

Date of Assessment: __ __ / __ __ __ / __ __ __ __
(DD / M M / YYYY)

__ __ / __ __ __ / __ __ __ __ ________:_______
Date & Time of Sample:
(DD / MMM / YYYY) HH:MM
No Yes, Complete below
Was laboratory sample taken at different hospital to
Laboratory name / Location:
<insert investigator’s site lab name>?
__________________________________________

<INSERT ASSESSMENT> Value Unit If parameter indicated as out of normal

range on report, please check if clinically
Laboratory Parameter
significant IF CS consider if it is an AE and
add to log (if appropriate):

No Yes

No Yes

No Yes

No Yes

No Yes

No Yes

No Yes

No Yes

No Yes

No Yes

Completed by (Name): Signature Date:

53
 Centre (Site) No. Subject No.
Screening No. Patient Initials

VISIT X <INSERT VISIT NAME> TRIAL MEDICATION ADMINISTRATION

Date of Assessment: __ __ / __ __ __ / __ __ __ __
(DD / M M / YYYY)
CHOOSE APPROPRIATE DOSING/DISPENSING TABLE FOR YOUR PROTOCOL AND MODIFY AS REQUIRED
Date of Dosing Time of Dosing Dose Comment ONLY if dose delayed, interrupted,
(DD/MMM/YYYY) (24 hr) (including units) reduced or altered

____/_____/______ ____ ____:____ __

____/_____/______ ____ ____:____ __

Start date of dosing Stop date of dosing Dose Comment ONLY if dose delayed, interrupted,
(DD/MMM/YYYY) (DD/MMM/YYYY) (including units) reduced or altered

____/_____/_____ ____/_____/_____

____/_____/_____ ____/_____/_____

INFUSION
Date of Infusion Start time of Stop time of Dose Comment if dose delayed,
(DD/MMM/YYYY) infusion infusion (including units) interrupted, reduced or altered

____/_____/______ ______:______ ______:______

____/_____/______ ______:______ ______:______

DISPENSING
Date of Dispensing IMP Quantity Dispensed (no. <Daily> Dose Comment ONLY if dose delayed,
(DD/MMM/YYYY) tablets/ pens/patches) (including units) reduced or altered

____/_____/______
Note: add more rows depending on how IMP is dispensed and returned
RETURNS (add to subsequent visit)
Date of Returning IMP Quantity Returned (no. Comment on compliance
(DD/MMM/YYYY) tablets/ pens/patches)

____/_____/______

Completed by (Name): Signature Date:

54
 Centre (Site) No. Subject No.
Screening No. Patient Initials

VISIT X <INSERT VISIT NAME> <ASSESSMENT PERORMED>

Date of Assessment: __ __ / __ __ __ / __ __ __ __
(DD / M M / YYYY)

<Insert other assessments>

Completed by (Name): Signature Date:

55
 Centre (Site) No. Subject No.
Screening No. Patient Initials

VISIT X <INSERT VISIT NAME> PRINICIPAL INVESTIGATOR’S SIGN OFF

Date of Assessment: __ __ / __ __ __ / __ __ __ __
(DD / M M / YYYY)

Principal Investigator’s Signature Statement:

I have reviewed this CRF and confirm that, to the best of my knowledge, it accurately reflects the study
information obtained for this participant for visit#1. All entries were made either by me or by a person under
my supervision who has signed the Delegation and Signature Log.

Principal Investigator’s Signature:

__________________________________

Principal Investigator’s Name: __ __/ __ __ __ / __ __ __ __

Date of Signature:
(DD / MMM / YYYY)
________________________________________

ONCE SIGNED, NO FURTHER CHANGES CAN BE MADE TO THIS PART OF CRF WITHOUT A
SIGNED DATA QUERY FORM.

56
Centre (Site) No. Subject No.
Screening No. Patient Initials

TRIAL COMPLETION

Yes, Please provide date of last visit:

__ __ / __ __ __ / 2 0 __ __
(DD / MMM / YYYY)

Did participant complete the trial?

No, Please provide date of withdrawal and
complete below:

__ __ / __ __ __ / 2 0 __ __
(DD / MMM / YYYY)

Early Withdrawal: please tick most appropriate reason for participant not completing the trial:

Adverse Events related: please state related AE: ____________________________________ (add details
to AE page)

Participant’s decision, specify: __________________________

Investigator’s decision, specify: __________________________

Sponsor’s decision

Lost to follow up

Patient deceased

Other, specify: __________________________

Completed by (Name): Signature Date:

57
 Centre (Site) No. Subject No.
Screening No. Patient Initials

ADVERSE EVENTS PAGE

Relationship to
Study Drug Outcome
Event Serious? Study Drug
Severity Action 0 - Resolved
Name If serious, Con- 0 - Definitely
0 - Mild 0 - None 1- Resolved
AE (Please Start date Stop date please comitant 1 - Probably
1- Mode- 1 - Temporarily with
No give (DD/MM/YY) (DD/MM/YY) complete Medication 2 - Possibly
rate Interrupted sequelea
Diagnosis if a JRO SAE given 3 - Unlikely
2 - Severe 2 - permanently 2 - Not
known) form 4 - Not related
withdrawn resolved
5 - Not assessable
No No
1 ___/___/___ Yes Yes
___/___/___
No No
2 ___/___/___ ___/___/___ Yes Yes
No No
3 ___/___/___ ___/___/___ Yes Yes
No No
4 ___/___/___ ___/___/___ Yes Yes
No No
5 ___/___/___ ___/___/___ Yes Yes
No No
6
___/___/___ ___/___/___ Yes Yes
I have reviewed the AEs on this page and have assessed them for seriousness, causality, severity and outcome and confirm that, to the best of my
knowledge, it accurately reflects the study information obtained for this participant
PI signature _______________________________ _________________ Date:_________________________ Please check box if this is the
last page used

Completed by (Name): Signature Date:

58
 Centre (Site) No. Subject No.
Screening No. Patient Initials

CONCOMITANT MEDICATIONS LOG

Reason for use Dose

Start date Stop date Or tick if
Medication name (Enter related AE (units)
CM ongoing at
(Record Generic (DD/MMM/YYY (DD/MMM/YY diagnosis, or other Route Frequency
No. end of
name) Y) reasons for use, e.g.
YY) study?
Prophylaxis)

1. ____/_____/___ ____/_____/__

2. ____/_____/___ ____/_____/__

3. ____/_____/___ ____/_____/__

4. ____/_____/___ ____/_____/__

5. ____/_____/___ ____/_____/__

6. ____/_____/___ ____/_____/__

7. ____/_____/___ ____/_____/__

8. ____/_____/___ ____/_____/__

9.

10.

11.

12.

13.

14.

15.

Completed by (Name): Signature Date:

59
Centre (Site) No. Subject No.
Screening No. Patient Initials

PRINCIPALE INVESTIGATOR’S SIGN OFF

Principal Investigator’s Signature Statement:

I have reviewed this CRF and confirm that, to the best of my knowledge, it accurately reflects the study
information obtained for this participant. All entries were made either by me or by a person under my
supervision who has signed the Delegation and Signature Log.

Principal Investigator’s Signature:

__________________________________
__ __/ __ __ __ / __ __ __ __
Date of Signature:
(DD / MMM / YYYY)
Principal Investigator’s Name:

________________________________________

ONCE SIGNED, NO FURTHER CHANGES CAN BE MADE TO THIS CRF WITHOUT A SIGNED
DATA QUERY FORM.

60
Chapter 2.
Initiation
Research Project Manager

61
Initiation

Those processes performed to define a new research project by obtaining authorization to

start the project or phase. Steps for initiation process will be:

 Define and writing a research proposal for a worthwhile idea provides a detailed

description to meet the standards.

 Ensure the commitment of the sponsor regarding financial aspects such as:

a. How to provide budget cost.

b. The way of payment to the research team, research support team and others.

 Ensure the commitment of the sponsor, IRB concerns, and/or Good Clinical Practice

standards.

 Ensure the submission of all essential documents for the conduct of a clinical trial.

 Ensure communication with other sections regarding research support team.

 Identify research team.

 Selecting the project manager if not already assigned.

 Selecting the site area to conduct the clinical trial.

It will be imperative for research project management professionals to work with researchers,

scientists, developers, and consultants to facilitate new product development and quality

initiatives. Within the Initiating processes, the primary and secondary (if any) aim of the
62
research project is defined and committed. Performing the Initiating processes at the start of

research project helps to keep the project focused on the main aim needs that the project to

address.

A research proposal is intended to convince others that you have a new idea. Generally, a

research proposal should contain all the key elements involved in the research process and

include sufficient information. The successful criteria are verified, and objectives of the

project are reviewed.

A research project manager must be appointed to sort out and management of the following

responsibilities:

1. Responsibility for clinical research project manager (CRM) with PI and Research team.

a) Review protocol(s) for investigational drug trials, as required.

b) Liaise with principal investigators and/or research team to distribute responsibilities.

c) Define the scope of work, then create work breakdown structure (WBS).

d) Determine sequence of activities.

e) Estimate activity duration.

f) Draw a work plan.

g) Define how to monitor the quality of the output and closing remark.

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2. Responsibility for clinical research project manager with regard finance processes.

(example attached)

a. Draft a budget for the clinical trial includes the following aspects:

1. Honorarium for PI, co-PI, sub-investigators, as a research team.

2. Compensation for the research technologists, phlebotomists, nurses, pharmacists,

data collection, secretaries and other research support team.

3. Compensation for consultant, biostatistician and other consulting team.

4. Equipment such as "instrument", "machine", "device," or "apparatus" to aid in

the diagnosis, monitoring or treatment of medical conditions.

5. Supplies (if it is not provided by the sponsor).

6. Others (specific)

7. Miscellaneous (nonspecific)

b. Determine sheet for income and expenditure.

3. Responsibilities for clinical research project manager with other sections/ department to

assign members for research supporting team (Pharmacy, Laboratory, other sections such

as radiology, Information technology, Administration etc..).

i. Pharmacy.

64
 a) Liaise with principal investigators and/or research team to establish pharmacy’s role,

and to implement dispensing, and compounding procedures (if any).

b) Although it is the responsibility of the PI for investigational drug availability, storage

and accountability at the trial site, yet the CRM should share this responsibility.

c) Together with the PI, they should be ensure that the code is disclosed only in

accordance with the protocol (in case of blind randomized trials).

d) Communicate with, and trains staff from pharmacy anticipated to participate in any

aspect of the clinical investigational drug trial.

e) Maintain a pharmacy binder which contains a study summary, protocol, dispensing

procedures, completed samples of required paperwork, dispensing checklist, fee

schedule, and any other relevant materials for each investigational trial.

f) Maintains responsibility for the management of the inventory for clinical

investigational drug trials; orders, replaces and returns study materials, as required.

ii. Laboratory.

a) Establish the role of the laboratory in the study.

b) Responsibility regarding blood withdrawn (phlebotomist)

c) Conducting biochemical tests

d) Ensure privacy of results.

65
iii. Other section such as radiology, information technology, administration etc..

a) Arrange subject’s appointments

b) Retrieve and collect data for analysis

c) Other support concerning research process.

4. Describe communication regarding IRB required documents

Check all documents before the clinical phase of the trial commences (listed in Clinical

Trials Requirements Guidelines (GCP) 8.2).

The essential documents are:

 Signed protocol and amendments, if any.

 Informed consent form (Including all applicable translations).

 Sample of case report form (CRF).

 Investigator's brochure to document that relevant and current scientific information

about the investigational product has been provided to the investigator.

 Financial aspects of the trial to document the financial agreement between the

investigator/institution and the sponsor for the trial.

 Curriculum vitas and/or other relevant document evidencing qualifications of

investigator(s) and sub investigators to document qualifications and eligibility to

conduct trial and/or provide medical supervision of subjects.

66
5. Communicates any concerns regarding ethical issues or deviation from established

policies and procedures to the Ethics Committee or IRB.

a) Before recruiting any patient for the clinical trial, PI and CRM should have written and

dated approval from the IRB for the trial protocol, written informed consent form,

inclusion and exclusion criteria, subject recruiting procedure, and any written information

to be provided to subjects.

b) During the trial, the PI and CRM should provide to the IRB/IEC all documents subject to

review.

c) The PI and CRM should conduct the trial in compliance with the protocol agreed to by

the sponsor and, if required, by the regulatory authority(ies). The PI and CRM and the

sponsor should sign the protocol, or an alternative contract, to confirm agreement.

d) The PI and CRM should not implement any deviation from, or changes of the protocol

without agreement by the sponsor and prior review and documented approval/

favorable opinion from the IRB/IEC of an amendment, except where necessary to

eliminate an immediate hazard(s) to trial subjects, or when the change(s) involves only

logistical or administrative aspects of the trial (e.g., change in monitor(s), change of

telephone number(s)).

67
e) The PI and CRM should document and explain any deviation from the approved

protocol.

f) The PI and CRM may implement a deviation from, or a change of, the protocol to eliminate

an immediate hazard(s) to trial subjects without prior IRB/IEC approval/favorable opinion.

As soon as possible, the implemented deviation or change, the reasons for it, and, if

appropriate, the proposed protocol amendment(s) should be submitted:

i. to the IRB/IEC for review and approval/favorable opinion,

ii. to the sponsor for agreement and, if required,

iii. to the regulatory authority(ies).

6. Initiate a review checklist for all responsibility of the project manager.

(see example)

68
FINANCIAL ASPECTS

The Principal Investigator has primary responsibility for developing a preliminary initial

budget (see example), including:

1. Personnel

PI should have estimate number for all subjects will participate in the trials and

estimate number of hours will be spend with, number of visits for each subject.

Professional fee schedule containing charges and fair market value costs for

physician’s professional fees per subject related to services rendered as part of the

study not as a part of standard care. Then fees will be counted according to:

1.1. Research Team

Principle Investigator, The head of research team.

Coinvestigator(s), usually the most active investigator next to the PI.

Sub-investigator(s), other research investigator and patients recruiters.

1.2. Research Consulting Team

Consultant, used to support the staff with scientific consultations and

advices.

Statistician, used to make data analysis and document review.

69
 Editor, to review document for publication(s).

Others, those who support or provide the research with single or

minor service.

1.3. Research Support Team

Including but not limited to:

Research assistance/ Research associate; Research coordinator; Research aides

Pharmacists; Nurses; Laboratory Technicians; Radiologists; Data collectors/ Data

Entry Clerks; Administrative assistants and Others, not mentioned above but

he/she spend a considerable time during the conducting of the research study.

2. Equipment

Principle investigator should have full idea about list of the equipment needed to be

purchased for the purposed research. Also, the PI should have idea about the fate of

the equipment including confirmation document provided from the chairman of the

section of the PI to secure the fate of this specific equipment. Medical or laboratory

equipment such as "instruments", "machines", "devices," or "apparatus" to aid in

the diagnosis, monitoring or treatment of medical conditions.

It is preferable if the PI to place a bid to show the cost of the equipment and ascertain if

there are other options or alternative(s) for such equipment with similar description

70
 and/or function. The main difference between equipment and supplies that supplies

are disposables while equipment need to be under the control of the property of the

same institution.

3. Supplies

In contrast to equipment supplies are mainly disposables. Supplies related to chemicals,

biochemicals or reagents, or related products that is used to diagnose, prevent, or treat

disease(s) or other conditions. Supplies are disposable products which may be used

within or on the body, usually used as adjunct for the provided equipment. Supplies

also include medical devices such as tongue depressors, medical thermometers,

disposable gloves, etc. to advanced devices such as computers and related spare parts

which assist to conduct medical testing.

It is also preferred if a quotation for the needed supplies is attached with the research

protocol.

4. Others

This budget category include known needed services not mentioned within the above

category such as:

4.1. Startup and other fixed cost fee schedules.

4.2. Costs associated with IRB review and oversight.

71
 4.3. Investigators Meetings.

4.4. Travel Expenses.

4.5. Laboratory fees.

4.6. Pharmacy charges.

4.7. Radiology and Other procedure technical fees.

4.8. Facility fees.

4.9. Subject cost(s).

4.10. Shipments.

4.11. Advertisement(s).

4.12. Training costs.

4.13. Others such as special supplies.

5. Miscellaneous expenses

Indirect costs on Study charges usually 10- 25% of the total budget. Miscellaneous used

as a loan expenses to the PI to be given from sponsor as a petty cash to be used only for the

same research project (not even for another research project of the same PI).

72
 RESEARCH FUND APPLICATION
Principal Investigator: __Xxx Yyy Zzz Protocol Number: __Res Prot. No. 2___
Duration: __Two (2) Years (24 months) Expected Starting Date: ____1/1/2016
Sample Size: __200 Patients (4 visits)___ Expected Completion Date: _31/12/2017_
Budget Category First Year Second Year Total Remarks
Quantity Unit Cost Quantity Unit Cost
Principal Investigator 1 20,000 1 20,000 40,000
Sub-Investigator(s) 4 50,000 4 50,000 100,000

Scientific Consultant 1 25,000 25,000

Personnel

Biostatistician 1 15,000 15,000

Research Nurse 200x2 50 200x2 50 40,000 No limit*
Technician 200x1 50 200x1 50 20,000
Interviewer 200x12 10 200x12 10 48,000 No limit*

Continuous Gluco- 20 10,000 200,000

monitor
Equipment

Laptops 4 5,000 20,000

Glucometers 200 free Donation

Strips 200x12 50 200x12 50 240,000

Supplies

Travelling 30,000
Accommodation 20,000
Others

Advertisement 10,000
Publication cost 10,000
Miscellaneous

50,000

GRAND TOTAL 868,000

*Nurse or technician is not limited for one person

73
 Checklist for CRM Responsibilities

YES NO NA CHECKLIST COMMENTS

1.Responsibility for CRM with PI and Research team
Review protocol(s) for investigational drug trials, as required
Liaise with PI and/or research team to distribute responsibilities.
Define the scope of work, then create work breakdown structure.
Determine sequence of activities.
Estimate activity duration.
Draw a work plan.
Define how to monitor the quality of the output and closing remark.
2. Responsibility for clinical research project manager with regard finance processes
Draft a budget for the clinical trial
Honorarium for PI, co-PI, sub-investigators, and research team
Compensation for research support team
Compensation for research consulting team
Equipment (if it is not provided by the sponsor).
Supplies (if it is not provided by the sponsor).
Others (specific)
Miscellaneous (nonspecific)
Determine sheet for income and expenditure
3. Responsibility for clinical research project manager with Other sections
Liaise with PI and/or research team to establish pharmacy’s role,
and to implement dispensing, and compounding procedures (if any).
Share the PI the responsibilities for investigational drug availability.
Together with the PI, ensure that the code is broken only in
accordance with the protocol and GCP standards.
Communicate with, and trains staff from pharmacy staff.
Maintain a pharmacy binder contains the protocol and fee schedule.
Maintains responsibility for the management of the inventory.
Arrange with phlebotomist to withdraw blood (if any)
Conduct chemical reagent control tests
Arrange for subject’s appointment and visits
Other communication
4.Describe communication regarding IRB required documents
Signed protocol and amendments, if any.
Informed consent form
Sample of case report form (CRF)
Investigator's brochure
Financial aspects of the trial with the sponsor for the trial
CV of PI and research team.

74
 Initiation questions
1- The processes preformed to define a new idea for a research project is
a) Initiation
b) Planning
c) Executing
d) Closing

2- All these steps is a part of initiation processes EXCEPT

a) Define and writing a research proposal for new idea
b) Ensure the commitment of the sponsor, IRB and good clinical practice standards
c) Recognize that there will be changes to your project and things will not go as precisely as anticipated
d) Identify research team

3- Within initiation processes ……….. of research project is defined and committed.

a) The primary aim only
b) The secondary aim only
c) The primary and secondary (if any) aim
d) No need to define any aim in this processes of the project

4- Always we need to perform the initiating processes

a) At the start of research project
b) At the middle of research project
c) At the end of research project
d) At any part of research project

5- Review protocol for an investigational drug trail is one of

a) Responsibility of CRM with regards finance processes
b) Responsibility for CRM with PI and research team
c) Responsibility of CRM with Pharmacy
d) Responsibility of PI with pharmacy

6- Which one of these is a responsibility of CRM with PI and research team?

a) Determine sheet for income and expenditure
b) Ensure that the code is broken only in accordance with the protocol
75
 c) Communicate and trains staff to participate in any aspect of the clinical investigational drug trail
d) Draw the work plan and estimate the activity duration

7- Which one of the following sentences is NOT true regarding responsibility of CRM with regards finance
processes?
a) Draft a budget for honorarium for PI , co-PI , sub investigator and research team
b) Draft a budget for research support team
c) Determine exact cost for the miscellaneous
d) Determine sheet for income and expenditure

8- Determine sheet for income and expenditure is one of

a) Responsibility of CRM with regards finance processes
b) Responsibility for CRM with PI and research team
c) Responsibility of CRM with other section
d) Responsibility of PI with other section

9- You are the CRM and you need to check all documents to get the IRB approval of the clinical study, which of
the following is NOT essential documents

a) Quotation for supplies

b) Informed consent form
c) Sample of CRF
d) Investigator's brochure

10- To document qualifications and eligibility to conduct trial or provide medical supervision of subjects we
need to have……. As essential documents
a) CRF
b) CVs of investigator and sub investigator
c) Sample of Informed consent form
d) Investigator's brochure

11- The PI and CRM should submit to the IRB /IEC all documents related to recruit subject to review

a) Before starting the trial

b) During the trial
c) At the end of the trial
d) At any time
76
12. Who should document and explain any deviation from the approved protocol?

a. PI and Sponsor
b. Sponsor and CRM
c. Sponsor and IRB
d. PI and CRM

13. Who is primarily responsible to develop preliminary initial budget that includes personnel, equipment,
supplies, other expenses directly or indirectly related to the conduction of the research study?

a. Principal Investigator
b. Clinical Research Project Manager
c. Sponsor
d. Research Support Team

14. Who among the following is not part of Research Consulting Team?

a. Consultant
b. Research Associate
c. Statistician
d. Editor

15. Which is the correct definition of Miscellaneous Expenses?

a. These are direct costs on the study
b. These are used as loan expenses to the CRM from the PI
c. These may be used in multiple studies of the same PI
d. These cost at least 10% of the total budget of a research study.

77
 Answers
1- The answer is (a) because this step is the initial step to start any project then we jump to planning then
executing then monitor this project and at the end closing
2- The answer is (c) because all the other answers is for initiation part except recognize the changing
which is for planning that come after initiation
3- The answer is (c) because in initiation processes we start to write the proposal and define our aim of
this project the primary or even secondary then we move to planning processes where we start to plan
to reach our aim
4- The answer is (a) Always we need to do this process at the starting of research project to keep the
project focused on the main aim need that the project to address
5- The answer is (b) in the beginning of any research the CRM need to review the protocol of
investigational drug with PI and research team
6- The answer is (d) the protocol of code broken and communicate and train staff are responsibilities of
CRM with pharmacy and determine sheet of income and expenditure is responsibility of CRM regard
finance processes
7- The answer is (c) because it is important to have a budget for equipment even if they are not
disposable
8- The answer is (a) we always need a sheet regarding income and expenditure in finance processes as a
responsibility of CRM
9- The answer is (a) as CRM you need to be sure that all your papers is ready and signed including
protocol and amendments
10- The answer is (b) It is essential to have CVs of investigator and sub investigator in order to document
qualifications and eligibility to conduct trail or provide medical supervision of subjects
11- The answer is (b) During the trial the PI and CRM should provide to the IRB /IEC all documents subject
to review
12- The answer is (d)
13- The answer is (a)
14- The answer is (b)
15- The answer is (d)

78
Chapter 3.
Planning
Research Project Manager

79
Planning
It is a fundamental property of intelligent behavior on how to create and maintain future

research projects. Making assignments and solving problems is a natural tendency of human

being. Taking time to think about what you are trying to do, how, when, and by whom,

characterizes of successful research projects. One of these early tasks is defining the

customer's needs. Recognizing patients requirement give the researchers the opportunity to

define the needs and how to make changes and, how to find and drive ways to solve these

needs.

Planning though is knowing how to arrange the needs in one scope to view the future of the

research in specific time and how to solve changes attributed to the main scope.

Planning in clinical research refers to the contract or agreement that the sponsor or the CRO

from on one side and clinical project manager and/or the site institution together with

principle investigator from the other side use to agree on the initial vision of the project

(scope, baseline, resources, objectives...) at a high level. The research project plan is the

document that the clinical project manager builds to describe in more details the planning of

the project and its organization.

The main objectives of a research project plan is to define the needs and scope of the research

study. Guidelines for specifying needs include the following rules:

1. State in simple words the requirements explicitly of your customers (patients).

80
 2. Assume any variation for these requirement.

3. Recognize that there will be changes to your research project and the scope of the work

will not go on precisely as anticipated.

4. Be transparent as possible, include pictures, graphs, physical models and other

nonverbal exhibits in the formulation of requirements.

5. Establish a system carefully to monitor any variables made to requirements.

6. Educate project staff and customers to the problems of specifying requirements.

The main goals of processing project management is to achieve the project objectives within

the constraints of scope, resources, time and budget. If the goals are the terminal

requirement, aim is the hope to achieve, then the objective is how to plan to achieve the goal.

Project management is the discipline of planning and organizing a project, and securing and

managing resources to achieve the goals of the project, project management thus involves a

set of skills, a suite of tools, and a series of processes. The elements of project planning and

management are thus employed in all research projects.

In order to make a plane for a classic research project, a similar stages for a research protocol

project should put in one frame with the following steps:

 Define a frame as the scope of the research.

 Identify a research problem.

81
  Refine and define aims and objectives.

 Design a research tools

Scope is the sum of products and services to be provided by the research project in one frame.

A written scope statement has to be developed including the research project problem and

justification, the major deliverables and research tools and the project objectives.

Major deliverables need to be decomposed into smaller using a work breakdown structure

(WBS) mechanism, to be more manageable components to provide better control. A WBS is

the scope of a research project that give a guide to carryout in conducting research. Scope

change control also has to be put in place early, covering: submission of change requests, their

evaluation, incorporating the approved changes in the plan and monitoring progress.

Activity definition is next, whereby the specific activities that must be performed in order to

produce the project deliverables are specified. Their sequencing and duration are determined,

producing a schedule. Resources required are now estimated and costs can be assessed.

Planning is also needed for:

• Project communications, who should get what data, how, when and where.

• Quality, identifying quality standards and ethical consideration relevant to the

research project.

82
 • Risk, determining if there is a side events are likely to affect the research project and

deciding how to handle them, and determine the way of reporting system.

• Procurement, deciding what to procure, and when.

• Organization, identifying, documenting and assigning project roles, responsibilities

and reporting relationships.

All these planning pieces are now put into one consistent, coherent research project plan

which will guide the research project manager on how to execute and control a clinical

research project. Ideally new thoughts may be added only after changes in scope. Baseline

means the original plan before adding a change. Plan management is enable the CRM to

develop and execute theories, administrative and controlling all related aspect to the research

project. CRM is responsible for conducting clinical research project and service delivery and

making the plans based on the findings of the research.

How to draft a work plan

A research project schedule is an outline of a set of aims and objectives for how to reach the

goals and processes by which a research team can accomplish those goals.

A work plan can be drafted to offer a better understanding of the scope of the research

project. That can be achieved with the following steps:

83
 1. Identify the aims and objectives of your research and how to reach the goals.

2. Identify how to process the research methodology.

3. Make WBS to achieve deliverables and more manageable components to provide better

control.

4. Consider ordering your work plan by "SMART" objectives.

5. Draft a Gantt chart to illustrate the start and finish dates of the main elements of the

research project.

Goal, Aim, Objective and Purpose

Goal is something has been achieved. It is a desired result(s) has been achieved as a terminal

point, the end toward which effort is directed.

Aim is something that you hope to achieve (so it is an attempt to direct to a target). This word

usually used in clinical trials since the principle investigators would like to get it.

Objective is something that you plan to achieve, expressing or dealing with facts or conditions

as perceived without distortion by personal feelings, prejudices, or interpretations. It is

extremely useful in helping to define and establish a research objectives to reassess while on

your goal path.

Purpose is the aim that someone wants to achieve, or that something is intended to achieve.

84
Identify how to process the research methodology.

Research methodology is the method applied to conduct the research project. The main

principles for the research methodology are: location, equipment and supplies and

technicians. Identifying research methodology is essential in writing your plan as a researcher.

In general research methodology that outlines the way in which research is to be undertaken

and, among other things, identifies the methods to be used in it. The next step for

methodology is how to collect data and how to analyze it. Research methodology could be

questionnaires (qualitative or quantitative), in the laboratory (measuring drug level and/or

monitoring, or measuring chemical results etc.), could a clinic visit or performing operation.

Work Breakdown Structure (WBS):

It is a tree structural view that shows a subdivision or breaking elements to a deliverable-

oriented decomposition of a project into smaller components. It is an essential tool for

planning and executing the project. A work breakdown structure is a key project deliverable

that organizes the team's work into manageable sections. The work breakdown structure can

be displayed in two forms one in form of a table with subdivision of tasks two in form of an

organizational chart. (Examples attached).

85
Use the WBS to define the work for the project and to develop the project's schedule. Work

Breakdown Structure Template with more detailed information on each component of the

WBS provides a common framework for the natural development of the overall planning and

control of a research project and is the basis for dividing work into definable increments. A

WBS can be developed by starting with the end objective and successively subdividing it into

manageable components in terms of size, duration, and responsibility (e.g., systems,

subsystems, components, tasks, sub-tasks, and work packages), which include all steps

necessary to achieve the objective.

Consider ordering your work plan by "SMART" objectives to guide the research project

management and research team responsibilities.

Specific: What methodology are the researchers going to perform for whom, what is the

direction for improvement, and is it significant? In order to reach a specific goal, it should

be clear and unambiguous. A specific goal will answer the following questions:

 What: What do I want to accomplish?

 Why: Specific reasons, purpose or benefits of accomplishing the goal.

 Who: Who is involved?

 Where: Identify a location.

 Which: Identify requirements and constraints.

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Measurable: Register all results and remember that a baseline number (control) needs to

quantify change. If a goal is not measurable it is not possible to produce or to know whether a

team is making progress toward successful completion, in-fact if a goal is not measureable that

mean this project have no aim. Quantify meaningful results or at least suggest an indicator of

progress. Measuring progress is supposed to help a team stay on track, reach its target on to

continued effort required to reach the ultimate goal. A measurable goal will answer questions

such as:

 How much?

 How many?

 How will I know when it is accomplished?

 Indicators should be quantifiable

Assignable: Specify who will do it in the time allotted with the available resources. It is

important that this criterion to be realistic and also attainable. Attainable goals are neither out

of reach nor below standard performance, which may be considered meaningless. Make

priority for the appropriate goals that are achievable and simple to come true. An achievable

goal will answer the question How?

 How can the goal be accomplished?

 How realistic is the goal based on other constraints?

87
Realistic: State what results can be relevant and realistically be achieved, given available

resources. Make sure your objectives and methods have a clear, intuitive relationship.

Relevant goals (when met) drive the team, department and organization forward. A goal that

supports or is in alignment with other goals would be considered a relevant goal.

A relevant goal can answer yes to these questions:

 Does this seem worthwhile?

 Is this the right time?

 Does this match our other efforts/needs?

 Are you the right person?

 Is it applicable in the current socio-economic environment?

• Time bound: Specify when this result will be accomplished, and to specify a hard end date

for the research project. Stipulate within a time-frame which, if any, outcomes would cause

your project to come to a premature end, with all outcomes having been achieved. A

commitment to a deadline helps the research team focus their efforts on completion of the

research project on or before the due date. This part of the SMART goal criteria is intended to

prevent goals from being overtaken by the day-to-day crises that invariably arise in an

organization. A time-bound goal is intended to establish a sense of urgency.

A time-bound goal will usually answer the question

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  When?

 What can I do six months from now?

 What can I do six weeks from now?

 What can I do today?

Ghant Chart

Draw a Gantt chart to illustrate work plan. It is a diagram to illustrate the start and finish dates

of the terminal elements. This diagram shows the process of analyzing research activity

sequences, durations, and resource requirements. It summarize the relationship of planning

and work breakdown structure (duration and responsibilities) of the research project.

(Example attached).

Steps to draw a Gantt chart diagram in excel sheet:

1. Identify aims and objectives for a research project and how to achieve the goals.

2. Identify how to process the methodology.

3. Make WBS for methodology to achieve tasks.

4. Specify duration for each task (in days, weeks and months).

5. Specify one or more of the research team (as responsible) to achieve a task in specific

duration).

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 6. Make order for the sequence of events.

7. Draw a diagram on excel sheet showing start and finish date for each task.

A Gantt chart is a diagram to show a summary of analyzing research activity sequences

through compromising the work breakdown structure of the research project in achievable

tasks with specific duration under the responsibility of the research team. Three main

elements to draw a Gantt chart namely, WBS, duration and responsibility. Through a work

plan, a Gantt chart will illustrate small pieces of the research project with achievable tasks able

to be accomplished in specific duration.

Draft a work plan after changes

Constraints are obstacles that may get in the way of achieving your goals and objectives. Scope

change, incorporating the approved changes in the plan and monitoring progress. Planning

though is the process where to organize a research project to achieve aims and objective of

that research. Changes are planning in the original processes that researchers don’t recognize

their needs that was none defined earlier, however, in case of research projects, it is

important to put in consideration that clinical research deals with human subjects therefore, if

any changes in a clinical research to keep in mind the reporting system to IRB, regulatory

authority and sponsor.

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In case of changes or variance in the baseline (plan before adding changes), researchers should

do the followings:

1. Define and refine the aims and objectives for the research project to achieve the new

goals.

2. Consider making WBS to achieve deliverables and more manageable components to

provide better control.

3. Draft a Gantt chart to illustrate the start and finish dates of the main elements of the

research project.

Reporting Systems

Reporting systems for a research project could be referred to those data gathering efforts

which get information on clinical trials. Reporting systems should constitute procedure for

gaining reliable and valid information about what is happening in each segment of the

research.

The CRM should provide PI and research team with the information they need to know the

status of the research project and how to proceed with the same plan. Recite details or

statistics from recent reports, identify problems that need to be addressed, or build off of

recommendations or feedback. The CRM also responsible to conduct meetings with all the

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research team so often. Agenda of each meeting should be written in collaboration of the CRM

and the PI (previous meeting between CRM and PI to specify the agenda).

The main reporting tools in clinical research studies is a clinical report form (CRF) which could

be printed format as a hard copy, optical, or electronic document designed to record all of the

research protocol events where it is required information specifically in clinical research to be

reported. A clinical report form (CRF) consist of:

 Section 1: Cover page and instructions

 Section 2: Screening (Screening No. can be added to the header in this section if

required instead of Subject No.)

 Section 3: Post randomisation/enrolment visits

 Section 4: Adverse events and concomitant medication(s)

 Section 5: PI sign off

Reports and communication is also a main task for the CRM, reporting in clinical trial such as:

 The investigator should submit written summaries of the trial’s status to the institution,

IRB, regulatory authorities annually, or more frequently, if requested by the IRB.

 The investigator should promptly provide written reports to the sponsor, the IRB and,

where required by the regulatory requirements, the institution on any changes

significantly affecting the conduct of the trial, and/or increasing the risk to subjects.

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 All serious adverse events (SAEs) should be reported immediately. The immediate and

follow-up reports should be with more detail. The investigator should also comply with

the applicable regulatory requirement(s) related to the reporting of unexpected serious

adverse drug reactions to the SFDA and the IRB.

 Adverse events and/or laboratory abnormalities identified in the protocol as critical to

safety evaluations should be reported to the sponsor according to the reporting

requirements and within the time periods specified by the sponsor in the protocol.

 For reported deaths, the investigator should supply the sponsor and the IRB with any

additional requested information (e.g., autopsy reports and terminal medical reports).

 If the trial is terminated prematurely or suspended for any reason, the investigational

institution should:

o Promptly inform the trial subjects,

o Assure appropriate therapy and follow-up for the subjects, and,

o Where required by the applicable regulatory requirement(s),

 Upon completion of the trial, the investigator should, where required by the applicable

regulatory requirements, inform the institution, and the IRB with a summary of the

trial’s.

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Essential documents should be retained until at least 3 years after the last approval of a

marketing application and until there are no pending or contemplated marketing applications

or at least 3 years have elapsed since the formal discontinuation of clinical development of the

investigational product. These documents should be retained for a longer period, however, if

required by the applicable regulatory requirements or by an agreement with the sponsor.

List resources.

Include anything that will be necessary to achieve your goals and objectives. Resources can be

any things within the financial budget including, personnel, equipment, supplies, etc. whether

if it is specific or non-specific. It is also recommended to list resources with sequence of

events.

Write a manuscript.

Use your resources and overcome your constraints in order to reach your goals and objectives.

List specific action steps for your methodology. Verify your data, then do analysis, draw

conclusions by evaluating your research questions, research objectives and research aim.

To prepare a manuscript, you may breakdown each step to minor and achievable task then use

this guide to write a manuscript:

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 Read the Guide for Authors: to think where you should submit your publication and

whether it is publishable or not.

 Decide what type of the manuscript to write and decide a target journal.

 Write the Materials and Methods, Describe your results, Discuss your findings, Write the

introduction, and References

 Create the title page

 Screen for the Rapid Rejection Criteria

 Rewrite your manuscript

 Circulate your manuscript

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References:
1. (https://federation.edu.au; 7.0 Project Planning and Management).

2. Essential Guide to Leading Your Team : How to Set Goals, Measure Performance and
Reward Talent. Pearson Education. pp. 37–39. ISBN 0273772449. Retrieved 2013-07-05.
Yemm, Graham (2013).
3. Successful Management by Motivation : Balancing Intrinsic and Extrinsic
Incentives. Springer. p. 234. ISBN 3540424016. Retrieved 2013-07-11. Frey, Bruno S.;
Osterloh, Margit (2002).
4. Social Work Management and Leadership : Managing Complexity with
Creativity. Routledge. pp. 84–85. ISBN 1135247056. Retrieved 2013-07-14. Lawler, John;
Bilson, Andy (2013).
5. http://www.elsevier.com/connect/six-things-to-do-before-writing-your-manuscript Six
things to do before writing your manuscript In this new series — “How to Prepare a
Manuscript for International Journals” — a seasoned editor gives advice to boost your
chances of acceptance By Angel Borja, PhD Posted on 12 May 2014.
6. A Step by Step Guide to Writing a Scientific Manuscript; Volker Wenzel, M.D., M.Sc.,
Martin W. Dünser, M.D.*, Karl H. Lindner, M.D.

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 Questions and Answers
1. The need to have enough ……………………In planning step of research project management is an
important issue to come with successful plan.
a) Money
b) Time
c) Scientists
d) Customers

2. One of the early task of planning:

a) Identify research team
b) Research time management
c) Identify research budget
d) Defining customer’s needs

3. Which of following is true regarding classic research project stage?

a) They are start with refine aim and objectives and end with writing the documentation.
b) Usually take place in closing process of research cycle
c) Start with identify research problem
d) PI alone must carry out this stages

4. Scope is the sum of products and services to be provided by the project, also needs careful attention.
And a written scope statement has to be developed that includes:
a) Major deliverables
b) Project justification
c) Project objectives
d) All of above

5. Project communications, quality assurance and risk management all need a good:
a) Planning
b) Executing
c) Control
d) Initiation

6. The original plans, plus or minus approved changes called:

a) Draft
b) Baseline
c) Research protocol
d) None of above

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7. Gant chart take place in:
a) Initiation
b) Planning
c) Executing
d) Controlling

8. Which of following is not true regarding Gant chart?

a) We draw a Gantt chart to illustrate a work plan
b) A Gantt chart illustrate the start and finish dates of elements of a project
c) It take place in planning process of research management cycle
d) It take place in initiation process of research management cycle

9. Usually the work plan for:

a) Certain period of time
b) Unlimited time
c) Depend on the nature of the project
d) None of the above

10. SMART objectives refer for:

a) Short, measurable, achievable, relevant and time bound.
b) Specific, measurable, accurate, relevant and time bound.
c) Specific, measurable, achievable, relevant and time bound.
d) Specific, measurable, achievable, relevant and talented.

11. In planning process you must list your resources which are anything that will be necessary for you to
achieve your goals and objectives and the most important thing to be included is:
a) Financial budget
b) Personnel
c) Equipment
d) Supplies

12. Which of following is true regarding constraint?

a) Never let the constraint change the scope of research
b) You must have plan B to overcome any constraint
c) Once the constraint appear we have to end our project
d) None of above

13. The following are the Planning purposes EXCEPT:

a. Solving problems
b. How to create and maintain
c. How to monitor any changes
d. Identify research team
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14. The driving force of the project are:
a. Changes
b. Aims
c. Objectives
d. Needs

15. When writing work plan we should consider "SMART" objectives which stands for:
a. Speed, Motivation, Art, Reliable, Time
b. Specific, Methodology, Achievable, Relevant, Time bound
c. Specific, Methodology, Attractive, Recruitment, Tables
d. None of the above

16. Specific in SMART objectives means:

a. Results
b. Objectives and methods have a clear relationship
c. Methodology
d. Specify a hard end date for the project

17. Time bound in SMART objectives means:

a. Do it in the time allotted with the resources we have available
b. Duration of Registering all results
c. Specify a hard end date for the project
d. None of the above

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 Answers
1. B. taking time at planning carefully to think about what you are trying to do, how, when, and by whom,
characterizes successful projects.
2. D. It is normal that the customer does not recognize his needs and cannot articulate them. Moreover,
needs will almost certainly change as the project moves forward.
3. C. the classic research project stages take place in planning process of research cycle and start with
identify a research problem.
4. D. a written scope statement has to be developed that includes the project justification, the major
deliverables and the project objectives
5. A. Project communications need planning to know who should get what data, when. Quality need
planning to identifying quality standards relevant to the project and determining how to satisfy them
and Risk need planning to determining which risks are likely to affect the project and deciding how to
handle them.
6. B. Baselines are the original plans, plus or minus approved changes; e.g., cost-baseline, schedule
baseline.
7. B. Gant chart take place in planning process
8. D. Gant chart take place in planning process to illustrate a work plan. A Gantt chart illustrate the start
and finish dates of elements of a project
9. A. most work plans are for a certain period of time (i.e., 6 months or 1 year) so that is will help the
individual keep track of his/her goals and progress.
10. C. SMART objectives refer for Specific, measurable, achievable, relevant, and time bound.
11. A. financial budget so that you can determine your overall research budget
12. B. Constraints are obstacles that may get in the way of achieving your goals and objectives. Scope
change (plan B) can be made with incorporating the approved changes in the plan and monitoring
progress and no need to end the project.
13. D
14. A
15. B
16. B
17. C

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Work Breakdown Structure for writing a Research Protocol 1/2

101
Work Breakdown Structure for writing a Research Protocol 2/2

102
103
 104
Ghant Project Planner Period Highlight: 10 Plan
PLAN PLAN PERCENT
ACTIVITY START DURATIONCOMPLETE PERIODS
Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9
Project summary 8 1 0%
Rational and background information 1 2 0%
References 1 2 0%
Study goals and objectives 1 2 0%
Study Design 3 2 0%
Methodology 3 7 0%
Safety Considerations 3 2 0%
Follow-Up 5 2 0%
Data Management and Statistical Analysis 6 3 0%
Quality Assurance 3 6 0%
Expected Outcomes of the Study 3 2 0%
Dissemination of Results and Publication Policy 3 2 0%
Duration of the Project 3 2 0%
Problems Anticipated 3 2 0%
Project Management 3 2 0%
Ethics 3 2 0%
Informed Consent Forms 3 2 0%
Budget 3 2 0%
Other support for the Project 3 2 0%
Curriculum Vitae of investigators 3 2 0%
Other research activities of the investigators 8 1 0%
Financing and Insurance 8 1 0%
 Chapter 4.
Methodology/
Execution
Research Project Manager

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Methodology/ Execution

The project methodology or project execution phase is the third phase in clinical research

project management and it is the longest phase in the research life cycle. During this phase,

the principle investigator together with clinical research manager will execute the tasks

described in the plans, processes, and implement procedures. Both PI and CRM will oversee

and manage the research resources as the detailed in the research protocol including all tasks

deliverables which was decomposed by WBS.

The PI and CRM must ensure that the observations and findings are recorded correctly and

completely in the case-report forms (CRFs) and signed by the responsible person designated in

the protocol. They have overall responsibility for ensuring the accuracy and completeness of

data entry. They must also ensure that the routine requirements for recording of data in the

source documents (e.g. hospital and laboratory records, consultation files) are met,

particularly those relating to the treatment given to the subject. Moreover, variation in the

research protocol or if there is an adverse event(s) should be reported in accordance with the

GCP standards.

If trial data are entered directly into a computer, there must always be an adequate safeguard

to ensure validation, including a signed and dated print-out and back-up records.

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Computerized systems should be validated and a detailed description for their use be

produced and kept up-to-date.

General consideration in methodology and execution

1. Select site area for patient recruitment.

2. Performs education responsibilities.

3. Provides accurate and efficient dispensing of medication.

4. Performs administrative responsibilities.

5. Provides direct and/or functional supervision; maintains overall responsibility for other

section(s) operations such as pharmacy, laboratory etc. in assigned area.

6. Performs communication responsibilities.

7. Performs cross-functional duties including Intra-venous admixture pharmacist, staff

pharmacist, patient care, as assigned.

8. Arrange for scientific gathering for the whole research team.

9. Distribute responsibilities among research team.

Professional responsibility

Professional responsibility is the area of ethical and moral duty of a researcher to what has to

be done, how and when to do it, in ways that encompasses the duties of attorneys to act in a

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professional manner, obey the law, avoid conflicts of interest, and put the interests of clients

ahead of their own interests. Professional responsibility as applied to researchers refers to the

ethical consideration permeating the researchers to work according to specific standards.

These standards relate to patient care, collaboration with other medical professionals,

integrity, morals and the responsibility to effectuate social change.

Three elements in the concept "professional responsibility", these are:

1. The effective use of knowledge, experience and technology of the researcher,

2. The suitability of the professional's attitudes and actions, and

3. The propriety of the professional's conduct in view of the profession's self-image and

defined interests.

These codes are implications about the subject matter development of the profession, skills

competency, ethical systems in conduct, and identity considerations.

Research Integration Management

Research integration management includes the processes and activities to review, identify,

define, combine, unify, and coordinate the various processes of research proposal.

Research integrated management can defined as incorporating the effective direction of

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research methodology so that the needs and expectations of all research team are equitably

satisfied by the best use of all resources. Research management should ensure to select or

create a research environment to manage the interdependencies in order to achieve the goals

within the plan.

Research project integration management is how to perform the research activities effectively

and efficiently under the GCP standards and after the IRB or ethics committee approval. It is a

commitment from all research team including the CRM to foster honesty and integrity, and to

respect for human research participants, animals and the health environment. It also ensures

that the research support team, equipment and supplies (resources), processes that are in

place, in use and will perform when required over the whole lifecycle of the research.

Research project integration management processes are as follow:

1. Collect all essential documents: Essential Documents are those documents that

individually and collectively permit evaluation of the conduct of a trial and the quality of

the data produced. These documents serve to demonstrate the compliance of the

investigator, sponsor, and monitor with the standards of GCP and with all applicable

regulatory requirements. All of the documents addressed in the clinical trials are

subjected for inspection by the SFDA or any regulatory authority.

2. Develop project management plan: The process of defining, preparing, and coordinating

all subsidiary plans and integrating them into a comprehensive research project

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 management plan. The project’s integrated baselines and subsidiary plans may be

included within the project management plan. The research plan may presented in a

Gantt chart to illustrate professional research project plan.

3. Direct and manage project work: The process of leading and performing the work

responsibilities defined during management plan including approved changes to achieve

the research objectives. Patient recruitment according to the inclusion and exclusion

criteria is part of this process.

4. Monitor and control project work: The process of tracking of all essential documents

reviewing changes and reporting project progress against the performance objectives

defined in the project management plan.

5. Perform integrated change control: This process is under monitoring and controlling

processes. If changes get raised in the executing process, the CRM and PI should

implement them and proceed as mentioned in “change management plan”.

6. Close project or phase: The process of finalizing all research activities across all of the

Project Management Process Groups. A checklist to be filled is an excellent idea to

ensure that all aspects of the research has been done properly and in the right

path. Also to assure that the research have a clear end-point. A research project that is

not closed will continue to consume resources.

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Research scope management

Project Scope Management includes the processes required to ensure that all the work

required to be accomplished successfully in terms of clinical and/or technical services,

products and results. “Scope” may refer to:

 Product scope—the features and functions that are to be included in a product or

service.

 Project scope—the work that must be done in order to deliver a product with the

specified features and functions

Research Project Scope Management include the following processes:

1. Plan Scope Management: The process of creating a scope management plan that

documents to describe how the project scope will be defined, managed, validated, and

controlled (monitored) throughout the research duration.

2. Collect Requirements: The process of determining, documenting, and managing

research team needs and requirements to meet project objectives. All requirements

should be gathered ahead of time which will ensure that it will meet the research team

expectation. Eventually this will show a professional attitude and will enhance research

development.

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 3. Define Scope: The process of developing a detailed description of the project and

product. Getting the scope just right on a project is one of the most-important elements

of achieving success in the end.

4. Create work breakdown structure (WBS): The process of subdividing project

deliverables and project work into smaller, more manageable components. A traditional

WBS for a research projects is usually divided at its highest level into phases of analysis,

design, coding, testing, and deployment activities. Each of these phases is then

decomposed into tasks or groups of tasks, referred to as research work packages.

5. Validate Scope: The process where research flow is suitable, and acceptable with all

research team (one hand) and sponsor. The assurance of understanding of verification

where it means the data outcomes comply with the methodology and validation means

the data outcome and results analysis meets the aim of the research project.

6. Control Scope: The process of monitoring the status of the research project and product

scope and managing changes to the scope baseline. Control scope is to compare the

baseline and requirements of the research methodology with the current actual results.

Research project time management

Research Project Time Management is the processes required to complete the research

project in the time allocated. The main concern is the time of the whole research team and

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research support team not just the time of the clinical research project manager. There is a

need to estimate all resources shared directly or indirectly in the research project. The CRM

should play a vital role in time management since most of the researchers do not plan or

manage their time. The Steps of the Time Management Process are as follow:

1. Plan Schedule Management: This step should be done upon the experience of the PI and

CRM. It should be done during the process of establishment of the research protocol.

This process will show hoe this project will be developed, managed, executed and how

to be controlled, and then after how it will be completed in a timely manner.

2. Define Activities: The process of identifying and documenting the research protocol to

be performed to produce various deliverable tasks. Deliverable tasks (WBS) are

activities with smaller decomposed components of the research project, which

represent the work necessary to complete the work package. These deliverable tasks

are subdividing into manageable components in terms of size (smaller decomposed

components), duration (time allocated), and responsibility (who will do the activity).

3. Sequence Activities: The process of identifying and documenting relationships and

dependencies that need to be included in the research project activities. After defining

the research proposal, a list of activities will be designed and created within the

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 research proposal, and then arrange this list of activities in a logical sequence showing

the order in which these activities must be performed.

4. Estimate Activity Resources: This is a fundamental step concerning the process of

estimating the type and quantities of material, human resources, equipment, or supplies

required to execute the research project. Estimation of type and quantity of resources

required, their availability, assumptions made, constraints discovered, and

dependencies found for each activity will make the estimate cost process easy hence

both are related to each other.

5. Estimate Activity Durations: The process of estimating the number of work periods

needed to complete the research project within the available resources. Resources are

include manpower (research support team), logistics (equipment and supplies), and site

where the research to be conducted. This is the main output from this process. It is not

right to assume that all activities will have one estimate as there are many techniques

and tools helping to give a range of estimates for each task. The knowledge, skills, sense

and experience in a CRM will improve the accuracy of such estimates. It might be

noticed that the sequence of events in time management process is to first define the

activities, then estimate the activity resources and then go on to estimate the activity

durations.
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 6. Develop Schedule: The process of analyzing activity sequences, durations, resource

requirements, and schedule constraints to create the project schedule model. The

project schedule (such as Gantt chart) is the tool that to show what work needs to be

performed, who is the responsible to perform the work and the timeline in which the

work needs to be performed. The schedule is the best tool for the work to be followed-

up by the CRM.

7. Control Schedule: The process where the CRM should monitor the status of project

activities and control the schedule and to update project progress, also the CRM should

verify changes to the schedule baseline to achieve the goal. The CRM should ensure

that the time spent on activities lines should match the schedule baseline. The CRM will

spend effort in controlling harder than planning the schedule because it requires one-to-

one management.

Research project cost management

Research Cost Management includes the processes required to measure the cost of the

research during all research life cycle processes including planning, estimating, budgeting,

financing, funding, managing, and controlling costs so that the research project can be

completed within the approved budget. The success of research cost control and

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management of depends on the CRM and the PI. The guidance of the PI and the management

of the CRM for the research project on how to do cost saving and to be in accordance with the

GCP and international standards. Cost management activities aimed at structural cost

management to improve performance for a research project.

The followings are Research Cost Management processes:

1. Plan Cost Management: The process that establishes the research budget with all the

criteria mentioned before, namely personnel, equipment, supplies, other and

miscellaneous. This process will provides guidance and direction on how the CRM will

manage the research costs throughout the research project. CRM will meet the PI

and/or the research team to present and review the cost performance every month and

also to report to the sponsor on quarterly basis (or according to the contract with the

sponsor whether if it is annually twice a year etc.).

2. Estimate Costs: The process to make estimation for the cost of every criteria listed in the

budget. Cost estimation is to give approximate cost of the monetary resources for each

activity of the research. There is no definitive estimate for the research cost, however,

creating a cost estimate depends on the CRM experience and also depends on the

sponsor’s rules and regulation. The estimate cost must be as accurate as possible so that

the comparisons with the real cost are meaningful.

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 3. Determine Budget: The process of collecting the estimated costs of each research

activity to present it in one sheet. Cost estimates are the estimated costs for each

research activity, whereas the budget allocates the costs over the life of the research

project to determine the quarterly and total funding requirements.

4. Control Costs: The process of monitoring and controlling changes in research project

budget. During this process, the CRM could have the capability to present and/or report

the status of the research budget and expenditures at any time. The report should show

real values with the approved cost base line and determining corrective actions. Both

cost estimates and budget are needed in order to determine the cost performance

baseline and the project funding requirements.

Research quality management

Quality Management includes the processes that determine policies, objectives, and

responsibilities to be followed to ensure that the project will satisfy the needs for which it was

undertaken. Quality management is a key element to achieve and sustain high quality output.

Research Quality Management works to ensure that the research project requirements are

met and validated. Most clinical research centers are encouraged to conduct clinical trials in

117
accordance with the ethical principle of Declaration of Helsinki and GCP standards and it

supports continuous process improvement activities.

In terms of Research Quality Management, there is no clear cut or indicator to measure the

research outcome.

Research Quality Management include the following processes:

1. Research Plan Quality Management: The process of define the scope of quality

requirements for a research project and its deliverables and documenting how the

project will demonstrate compliance with quality requirements and/or standards.

Research Quality Management Plan is to describe how research methodology will be

managed throughout the lifecycle of the research project. It may include the processes

and research methodology for ensuring quality planning, assurance, and control are all

conducted. All research team should be familiar with how quality will be planned,

assured, and controlled.

Good clinical practice possesses a research project standards such as research project

processes, product functionality, regulatory compliance requirements, project

deliverables, project management performance, documentation, testing, etc.

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 The Quality Management Plan for a clinical research documents the necessary

information required to effectively manage the research project quality from research

project initiation to closing.

2. Perform Quality Assurance: The process to ensure that appropriateness of quality

standards and operational function to meet the organizational standards and their

quality requirements.

The quality manager will provide day to day quality management and conduct process

audits on a weekly / monthly basis, monitor process performance metrics, and assure all

processes comply with project and organizational standards. If there is discrepancies or

variance, the quality manager will meet with the Project Manager to review and verify

the identified discrepancies.

3. Control Quality: The process of monitoring and recording results of executing the quality

activities to assess performance and recommend necessary changes. Research quality

control is a procedure or set of procedures to ensure that the research outcome should

adheres to a defined set of quality criteria or meets the requirements of the research

project. Monitoring and recording results of executing the quality activities must be

119
 ongoing to ensure that remedial efforts have produced satisfactory results and to detect

recurrences or trouble in research processes.

A suitable validated method for solving the problem will exist and may be in regular use.

The degree of associated staff training, calibration and quality control used with the

method will depend on sample throughput.

Research project human resource management

Research Project Human Resource Management includes the processes that organize, recruit

(part time), manage, and lead the research project support team from the operation

prospective not from the scientific. Generally, human resources management consider the

following aspects: human resource planning, reception or organizational entry, selection, job

analysis, remuneration, performance assessment, training and career planning. However, in

research needs some modification since most of the research team members are assigned

part-time with variable skills and may there will be addition or removing from the team as the

research progresses.

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The whole research team are consisting of the following groups:

First: Research team

These are the research investigators which they should have recognized qualifications

(education, training and experience). Research team main purpose is providing scientific

information and theories for the purpose of discovery, innovation, and interpretation or

developing methods. The research team consisting of:

1. Principle investigator (PI): is the lead scientist for a particular well-defined research

project. PI is the leader for the whole research project from all meanings, and is the

most responsible person in the research team. PI should comply with all institutional

instructions related to research.

2. Main PI: is the leader for multicenter research study, have similar definition for the

and also have same responsibilities to the PI.

PI have the following main responsibilities:

 Scientific: preparing the research proposal and making full scope for the

research project.

 Technical: Identify the needs, request and approve all the agreements.

 Financial: proposing budget, preparing expenditure log sheet and approve all

payment related to the research project.

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  Administrative: Ensure all regulatory requirement issues are completed,

collecting all required documents, submitting documents to regulatory

authorities and supervising all processes of the research projects.

3. Co-Principle Investigator (Co-PI): is the person who takes direct responsibility next to

the PI for completion of a research project. CO-PI have almost similar authorities to

the PI except in the financial aspects.

4. Sub-investigators: one or a group of scientists working together to complete a

research project under the leadership of the PI. The main responsibility for the sub-

PI is patient recruiting

It is worth to mention that one or more of the investigators should be a qualified physician to

be responsible for all clinical trial-related medical decisions.

Second: Research support team

These are one or a group of coworkers that have the impact to execute the methodology

according to the instruction of the research team such as Technologists, Nurses, Pharmacists

Phlebotomists, etc. Their aim is to facilitate the research processes as possible. Recruiting the

research support team through part-time is more reliable and convenient for both parties,

however, there are support team which are usually working in research institution and

working as full time.

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These are:

1. Research Project Manager also known as clinical research project manager (CRM): The

research project manager is the person assigned by the organization to lead the team

that is responsible for achieving the research objectives. CRM is reporting to the

principle investigator while the research is conducting and after completing the clinical

research will report to the research organization. CRM has responsibilities for over-

seeing all aspects of the day-today activities in pursuit of a project, including

coordinating staff, allocating resources, managing the budget, and coordinating overall

efforts to achieve a specific, desired result. CRM is the operation manager for a

research project, therefore, CRM is responsible for preparing everything to the PI except

scientific information (some PI recruit CRM with good clinical background which also

prepare literature review and provide scientific information and this this very possible

and more reliable for both PI and CRM).

2. Clinical Research Coordinator (CRC): To coordinate and facilitate various assigned clinical

research projects to ensure its compliance of the institutional policies and procedures,

the International Conference on Harmonization for Good Clinical Practice and the

international standards. CRC have more responsibilities such as:

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 To provide a leadership role in research protocol development and evaluation of

feasibility of research projects and mentoring junior Clinical Research Coordinators in

accordance with institutional policies and procedures and international standards.

 Implement the practice of the regulatory frameworks and legal requirements associated

with the planning, undertaking and closure of clinical research studies.

 Ensure protection of a research participant’s confidentiality.

 Provide comprehensive advice and guidance on matters relating to research ethics and

governance.

 Supervise the collected data inserted the data in the proper Case Report Form (CRF) or

other research storage formats in a safe and secure storage of data.

 Leads significant contribution to the preparation of documentation and submission of

application to IRB, as agreed within the research team.

3. Research associate will assist the Research team in administration and supervisory

aspects and clinical research activities, in-terms of supervising research assistants,

technologists, research technicians and research coordinators in the absence of the

immediate supervisor.

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 4. Research assistant (RA) is responsible for performing, assisting, participating and

working on clinical research projects related to improvement of health outcomes in

compliance with the institutional policies and procedures. RA is with higher level

compared with CRC or RT, yet is less than research associate in the HR ladder.

5. Research Technician (RT): To perform and report a variety of laboratory procedures as

assigned and as needed for research and diagnostics.

6. Research Aide will work under general direction by the Researchers/Principal

Investigators to support all technical and administrative operations in accordance with

the institutional policy and procedure.

Third: Research consulting team

Research consulting team are consultants individual that have the ability to provide a

consultation to a research project such Biostatistician, Epidemiologist, consultant or professor

from the same field. These individuals have minor impact(s) on the research project yet their

value is very high. It is important to list their fees in the budget preparation and if there is a

contract or a word of mouth between the PI and any of the consultant(s).

Research Project Human Resource Management processes, which are as follows:

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1. Plan Human Resource Management: The process of identifying and documenting

project roles, responsibilities, required skills, reporting relationships, and creating a

staffing management plan. PI and CRM will assign roles and responsibilities to research

team, research supporting team and research consulting team. CRM will work as a team

builder, assess and improve research support team.

2. Acquire Research Project Team: The process of focused on implementing human

resource availability and obtaining the right people working on the research project till

complete research activities. Right people mean individuals with the right knowledge

skills and experience that are available to carry out the work assignments within a given

time frames.

3. Develop Research Project Team: The process of team building and overall team

environment to enhance research project performance. Although it should be

presumed that research support team are the right people (above) where they should

have excellent information and experience yet this is a research project where most

things are for discovery and innovation which should be need training for the tools or

technique. This will be definitely resulting to a high efficient research team.

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 4. Manage Research Project Team: The process on how to track research team member

how is their performance, how to provide feedback, and resolving and managing

changes to get precise performance for the research project. CRM must be sure that

the research support team perform exactly according to the research project

management plan.

Research communication management

Research Communications Management includes the processes to ensure smooth flow

information between one or a group of the research team and the others in a subject related

to the research project. This process needs appropriate planning, collection, creation,

distribution, storage, retrieval, management, control, monitoring, and the ultimate disposition

of research information.

Effective communication creates a bridge between research team who may have different

cultural and organizational backgrounds, different levels of expertise, and different

perspectives and interests. Research Communications have an influence upon the research

execution and outcome.

Research Communications Management include the following processes:

1. Plan Communications Management: The process to find how and when the research

team receive information, and communicate with each other based on research team
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 needs and requirements. Plan Communications process involves determining what kind

of information should be shared with or between the whole research team. The

standard methods of communication that are widely used across the world are either

written or oral methods.

The communication activities involved in these processes may often have many potential

dimensions that need to be considered, including, but not limited to:

• Internal (within the research team) and external (customer, vendors, other research org);

• Formal (reports, minutes, emails, memos) and informal (briefings, ad-hoc discussions);

• Vertical (up and down the organization) and horizontal (with peers);

• Official (newsletters, annual report) and unofficial (off the record communications); and

• Written and oral, and verbal (voice inflections) and nonverbal (body language).

2. Manage Communications: The process of creating, collecting, distributing, storing,

retrieving and the ultimate disposition of research information. Communication

between research team should be continuous, particularly during periods of change in

the research process or adverse drug reaction.

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 3. Control Communications: The process of monitoring and controlling communications

throughout the entire research life cycle to ensure the exchanged information of the

research team are met. Effective management is to document the issues and monitor

its resolutions

Research risk management

Research Risk Management includes the processes of conducting risk management planning,

identification, analysis, response planning, and controlling risk on a research project. The main

objectives for risk management is to identify, assess, and prioritize of risk. The objectives of

research risk management are to increase the likelihood and impact of positive events, and

decrease the likelihood and impact of negative events in the research project. The impact of

positive effect in the clinical trials show the pharmaceutical product efficacy, while the

negative impact is the adverse drug reaction of the same pharmaceutical product.

Research Risk Management include the following processes:

1. Plan Risk Management: The process of defining how to establish risk management

activities for a research project.

2. Identify Risks: The process of determining which risks may affect the research project

and documenting their characteristics. Identifying risks may depend on the product,

practice and patient compliance. The identification methods for most of adverse event

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 came from nurses and confirm by the responsible physician. All adverse drug reactions

(ADRs) that are both serious and unexpected are subject to expedited reporting.

3. Perform Qualitative Risk Analysis: The process of prioritizing risks by a second

confirmation if the adverse drug reaction is unexpected. Fatal or life-threatening,

unexpected ADRs occurring in clinical investigations qualify for very rapid reporting.

Regulatory agencies should be notified (e.g., by telephone, facsimile transmission, or in

writing) as soon as possible but no later than 7 calendar days after first knowledge by

the sponsor that a case qualifies, followed by as complete a report as possible within 8

additional calendar days. This report must include an assessment of the importance and

implication of the findings, including relevant previous experience with the same or

similar medicinal products.

4. Perform Quantitative Risk Analysis: The process of numerically analyzing the effect of

identified risks on overall research objectives. Many terms and scales are in use to

describe the degree of causality between a medicinal product and an event, such as

certainly, definitely, probably, possibly or likely related or not related.

5. Plan Risk Responses: The process of developing options and actions to enhance

opportunities and to reduce threats to research objectives. Serious, unexpected

reactions (ADRs) that are not fatal or life-threatening must be filed as soon as possible

but no later than 15 calendar days after first knowledge by the sponsor that the case

meets the minimum criteria for expedited reporting.

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 6. Control Risks: The process of implementing risk response plans, tracking identified risks,

monitoring residual risks, identifying new risks, and evaluating risk process effectiveness

throughout the research project. Information for final description and evaluation of a

case report may not be available within the required time frames for reporting outlined

above. Nevertheless, for regulatory purposes, initial reports should be submitted within

the prescribed time as long as the following minimum criteria are met: an identifiable

patient; a suspect medicinal product; an identifiable reporting source; and an event or

outcome that can be identified as serious and unexpected, and for which, in clinical

investigation cases, there is a reasonable suspected causal relationship.

Research procurement management

Research Procurement Management includes the processes necessary to purchase or acquire

products, services, or results needed from outside the institution to perform a research. It

involves considering whether to procure, how to procure, what to procure, how much to

procure, and when to procure. Research Procurement Management includes purchase orders,

the contract management and change control processes required to develop and administer

contracts or purchase orders issued by authorized research team members.

Research Procurement Management also includes controlling any legal contracts issued by an

outside contract research organization or pharmaceutical companies such as “clinical trials”,

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that will require outside resources, services, products to be able to meet the research

objectives. The scope statement of procurement is to provide the product description,

acceptance criteria, delivery, and constrain about the project.

Research Procurement Management include the following processes:

1. Plan Procurement Management: The process of documenting research procurement

decisions, specifying the approach, and identifying potential sellers. Procurement officer

needs to have skills in understanding social, political, legal, and financial implications to

manage procurement process; also should have direct communication with the CRM.

2. Conduct Procurements: The process of obtaining seller responses, selecting a seller, and

awarding a contract. Direct procurement occurs in should be consider all the research

life cycle. It is not acceptable to stop methodology process of a research.

3. Control Procurements: The process of managing procurement relationships, monitoring

contract performance, and making changes and corrections as appropriate.

Subsequence to any changes will lead to purchasing more

4. Close Procurements: The process of completing each research procurement. It is the

responsibility of the CRM to keep all manuals, invoices, and records until the end of the

research life cycle. Closed Procurements involves reviewing the payment invoices,

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 contract, and providing a formal written intimation to the seller. Department of

property should record all purchased equipment during the research processes as assets

to the organizational. The CRM should ensure that all payment were received by

vendors.

Research team management

Research Team Management includes the processes required to be able to administer and

organize the whole research team. CRM should have the impact to analyze research team

expectations and their impact on the research project, and to how develop appropriate

management strategies for effectively engaging research teams in research project decisions

and execution. Principle investigator and CRM are also focus on continuous communication

with research teams to understand their needs and expectations, addressing issues as they

occur, managing conflicting interests and fostering appropriate research team engagement in

research project decisions and activities. CRM will first evaluate the objective of the research

team to understand what is needed to accomplish the task. Then, the CRM should identify the

strengths and weaknesses and to ensure that all research team members know what each

other’s responsibilities are to avoid confusion and to create an effective channels of

communication.

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For a clinical research, the principle investigator and CRM processes that include the following:

1. Identify Research teams: The process of identifying the people, groups, or organizations

that could impact or be impacted by a decision, activity, or outcome of the research

project; and analyzing and documenting relevant information regarding their interests,

involvement, interdependencies, influence, and potential impact on research success.

2. Plan Research team Management: The process of developing appropriate management

strategies to effectively engage research teams throughout the research life cycle, based

on the analysis of their needs, interests, and potential impact on research success.

3. Manage Research team Engagement: The process of communicating and working with

research teams to meet their needs/expectations, address issues as they occur, and

foster appropriate research team engagement in research activities throughout the

research life cycle.

4. Control Research team Engagement: The process of monitoring overall research team

relationships and adjusting strategies and plans for engaging research teams.

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References:
1. Robert S. Redmount; New Dimensions of Professional Responsibility: The Journal of the
Legal Profession 43-56.
2. Stephanie Reid, Demand Media; What Is Professional Responsibility in Nursing?
3. Ian Dalling “Integrated Management Definition”, Chartered Quality Institute Integrated
Management Special Interest Group, Issue 2.1 (2007:3).
4. Harald A. Mieg, Wilfried Endlicher, and Hadia Köhler; Four types of knowledge
integration management in interdisciplinary research on cities and the environment.
Cities and the Environment 1(1):2008
5. Paul Newton. Managing Project Scope - Free Management eBooks, 2015 www.free-
management-ebooks.com/dldebk-pdf/fme-project-scope.pdf
6. Cynthia Snyder Stackpole; Validate Scope Basics and the Flow of Deliverables for the
PMP Certification Exam, from PMP Certification All-in-One For Dummies, 2nd Edition.
7. Project Time Management – TutorialsPoint
www.tutorialspoint.com/management.../project_time_management.htm
8. Robin Henderson; Research Project Management Key Concepts
[email protected] ; My consultant, 2010
9. Shannon W. Managing Costs and Cost Structure throughout the Value Chain: Research
on Strategic Cost Management. In: Chapman, C., Hopwood, A. and Shields, M. (2006)
Handbook of Management Accounting Research. Vol 2. Oxford: Elsevier.
10.Qun Gao; Research on Cost Control and Management of Real Estate Project.
International Journal of Business and Management. Volume 4, No. 12 December, 2009.
School of Business Administration, Nanjing Institute of Industry Technology Nanjing
210046, China
11.Vinod Kumar, Dong-Young, and Uma Kuma; Quality management in research and
development.
12.International Journal of Quality and Service Sciences Vol. 4 No. 2, 2012 pp. 156-174.
13.Barbara B. Flynn, Roger G. Schroederb, and Sadao Sakakibara. A framework for quality
management research and an associated measurement instrument. Journal of
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14.Quality Management - Harvard School of Public Health
www.hsph.harvard.edu/clarc/quality_management.pdf

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15.Adams C, Cammann K, HA Deckers, et al. Quality Assurance for Research and
Development and Non-routine Analysis. October 1998 . www.citac.cc/rdguide.pdf
16.Project Human Resources Management -
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International Journal of Project Management. Vol 10 No 2 May 1992 .
18.Communication: - Project Management Institute
https://www.pmi.org/~/media/.../Communications_whitepaper_v2.ashx
19.Mary Young, and James E. Managing to communicate, communicating to manage: How
leading companies communicate with employees.
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Taylor & Francis Group.
21.Human Resource Development Quarterly. 2008. Defining Team Roles and
Responsibilities. [Instructor Guide]. Pennsylvania: Human Resource Development
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(External Consultant). Good Practice in Leading and Supporting a Research Team: A
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Second Edition.

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 Questions – Methodology/ Execution

1. Project methodology or project execution phase is defined EXCEPT:

a. The third phase in the clinical research project management
b. The phase where only PI oversee and manage the resources
c. The phase where tasks defined in the plans, processes and implementing procedures will be
executed
d. The longest phase in the research life cycle

2. In this stage, which among the below statements is INCORRECT:

a. PI and CRM have overall responsibility for ensuring the accuracy and completeness of the data
entry.
b. Any variation or adverse event(s) should be reported in accordance with the GCP standards.
c. Routine requirements particularly those relating to the treatment given to the subject are met.
d. PI and CRM may partially record in the CRF their findings.

3. It is defined as the ethical and moral duty of a researcher to what has to be done, how and when or an
ethical consideration permitting the researchers to work according to specific standards.
a. Professional Manner
b. Moral Integrity
c. Professional Responsibility
d. Moral Responsibility

4. The terminology that can be defined as incorporating the effective direction of research methodology
so that needs and expectations of all research team are equitably satisfied by the best use of all
resources is called ____________________________________?
a. Research Integrated Management
b. Professional Responsibility
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 c. Research Project Integration Management
d. None of the Above

5. What process in the research project integration management pertains to the process of tracking all
essential documents, reviewing changes & reporting project progress against the objectives?
a. Collect all essential documents.
b. Direct and manage project work.
c. Monitor and control project work.
d. Perform integrated change control.

6. What process in the research project integration management that process is defined, prepared, and
coordinated all subsidiary plans and integrated them into a comprehensive research project
management plan?
a. Monitor and control project work.
b. Develop project management plan.
c. Direct and manage project work.
d. Close project or phase.

7. The following processes are included in Research Project Scope Management, EXCEPT:
a. Evaluate Scope
b. Plan Scope Management
c. Control Scope
d. Define Scope

8. In the creation of work breakdown structure (WBS), what do you call each of the phases that are
decomposed into tasks or groups of tasks?
a. Work Breakdown Structure
b. Deployment Activities
c. Research Project Phase
d. Research Work Packages

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9. What should be the main concern to be considered at the Research Project Time Management phase?
a. The time of the whole research team , of the research support team and of the Clinical
Research Project Manager
b. Just the time of the Clinical Research Project Manager
c. The time of the Principal Investigator and Clinical Research Project Manager
d. None of the above

10. What is considered as the main output of the Time Management Process?
a. Deliverable Tasks
b. Estimate Activity Durations
c. Sequence Activities
d. Control Schedule

11. What do you call the costs over the life of the research project that determines the quarterly and total
funding requirements?
a. Cost Performance
b. Cost Estimates
c. Budget
d. None of the Above

12. Who should be familiar with how quality will be planned, assured and controlled in a research project?

a. Principal Investigator and Clinical Research Project Manager

b. Clinical Research Project Manager and the Management

c. Principal Investigator and Sub-investigator

d. All Research Team

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13. What should the quality manager do during occurrence of discrepancy or variance in a research
project?
a. Meet with the Project Manager to review and verify the identified discrepancy.
b. Meet with the Principal Investigator to review and verify the identified discrepancy or variance.
c. Meet with the Research Team to review and verify the identified discrepancy or variance.
d. Meet with the Project Manager to set procedures to ensure compliance.

14. Which of the following aspects is not being considered in Human Resources Management of a research
study:
a. Human Resource Planning
b. Estimate Activity Resources
c. Job Analysis
d. Performance Assessment

15. The following team made up the complete research team, EXCEPT:
a. Research Team
b. Research Support Team
c. Administration Team
d. Research Consulting Team

16. How does an occurrence of serious but non-fatal adverse drug reaction should be handled?
a. Report to the regulatory agencies as soon as possible or not later than 7 working days.
b. Must be reported as soon as possible but not later than 15 working days after first knowledge
by the PI that the case meets the minimum criteria for expedited reporting.
c. Must be reported as soon as possible but not later than 15 working days after first knowledge
by the research team that the case meets the minimum criteria for expedited reporting.
d. Must be reported as soon as possible within 15 calendar days after first knowledge by the
sponsor that the case meets the minimum criteria for expedited reporting.

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17. What do you call the document that provides the product description, acceptance criteria, delivery and
constraint about the project?
a. Legal Contracts
b. Purchase Orders
c. Scope Statement of Procurement
d. Procurement Management

18. Who should have the skills in understanding social, political, legal and financial implications to
management the procurement process?
a. Principal Investigator
b. Procurement Officer
c. Clinical Research Project Manager
d. Vendor

19. The following are the reasons why Principal Investigator and Clinical Research Project Manager should
also focus on continuous communication with research team, EXCEPT:
a. To convey the demands and expectations of the sponsor
b. To understand their needs and expectations
c. To address issues as they occur
d. To manage conflicting interests and to foster appropriate research team engagement

20. What phase of this chapter that has influence on the execution and outcome of the research study?
a. Research Quality Management
b. Research Risk Management
c. Research Cost Management
d. Research Communications Management

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 ANSWERS
1. b. Project execution phase is the third phase, it is the longest phase in the research and will execute
the tasks described in the plans, processes, and implement procedures.
2. d. One of the research support team should do the recording in the CRF.
3. c. Professional responsibility.
4. a. Research Integrated Management.
5. c. The process tracking all essential documents is Monitor and control project work.
6. b. The process defined, prepared, and coordinated all subsidiary plans and integrated them into a
comprehensive research project management plan is Develop project management plan.
7. a. Evaluate Scope.
8. d. Research Work Packages.
9. a. The time of the whole research team is the main concern.
10. b. The main output of the Time Management Process is to Estimate Activity Durations.
11. c. Budget is the costs over the life of the research project.
12. d. All research team should be familiar with how quality will be planned, assured and controlled in a
research project.
13. a. The quality manager should meet with the Project Manager to review and verify the identified
discrepancy.
14. b. Estimate Activity Resources.
15. c. Administration team.
16. d. An occurrence of serious but non-fatal adverse drug reaction must be reported as soon as possible.
17. c. Scope Statement of Procurement provides the product description, acceptance criteria, delivery and
constraint about the project.
18. b. Procurement Officer should have the skills in understanding social, political, legal and financial
implications to management the procurement process.
19. a. To convey the demands and expectations of the sponsor.
20. d. Research Communications Management.

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 Chapter 5.
Monitoring and
Controlling
Research Project Manager

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RESEARCH PROJECT MONITORING AND CONTROLLING

The Monitoring and Controlling is the process to confirm that all tasks of the research project

that was approved by the IRB and regulatory authorities and getting authorized for conduction

should be within scope, on time, and on budget so that the research project proceeds with

minimal risk. This process encompasses comparing tangible performance with planned

performance baseline and taking corrective action to get the desirable research. Monitoring

and Controlling process is continuous assessment throughout the life cycle of the research

project. It aims to provide the sponsor with early detailed information on the progress or

delay of the clinical research.

The research project control is a key member of the project management and works directly

with the research project manager (CRM) to help define the project's goals and objectives;

create and maintain a project's budget and schedule, analyze progress reported against the

work schedules; and recommend actions to improve progress. Planning and control are at the

opposite sides of the same coin. In order to ensure accurate documentation and reporting on

a consistent basis, many organizations are positioning the project manager and project

controller as part of a centralized project support organization.

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Monitoring and controlling processes is to observe research project execution in order to

identify any problem or variance from the proposed methodology and find ways for corrective

action. The key benefit of monitoring and controlling is that project performance is observing

and measuring regularly to identify variances from the project management plan. The

monitoring and control process should implement corrective or preventive actions to bring the

project into compliance with the project management plan. Monitoring the research project

variables against the project management plan and the project performance baseline is

important to justify a potential research outcomes.

Project monitors should ensure that the clinical trial is conducted and documented properly,

including laboratories. Project monitors should also ensure that equipment are adequate to

safely and properly conduct the trial throughout the trial period. Moreover, verifying that the

investigational product(s) are supplied and stored in acceptable conditions. Project manager

on the other hand, pays particular attention to unacceptable variances in the protocol and

those that cannot be tolerated, such as in case adverse drug reaction for an investigational

drug. Important question(s) should always be asked in clinical trials involving drugs, such as:

Can we live with a side effect of a medication? Or: Can we live without this medication? This is

exactly similar to the argument of the IRB committee to make their decision to eliminate an

immediate hazard(s) to trial subjects in case of clinical trials.

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Project monitors should has an ongoing responsibility for the ethical conduct of research, and

therefore must be informed of all subsequent amendments to the protocol and if there is any

serious adverse events occurring during the trial, or other new information likely to affect the

safety of the subjects or the conduct of the trial. Monitors should convey their opinion(s) and

advice(s) in writing to the IRB within a reasonable time, clearly identifying the trial protocol,

itemizing the documents studied and stating the date of review.

Monitors should consider the following:

1. The acceptability of the investigators qualifications, experience, availability for the

duration of the study, supporting staff and available facilities and to comply with the

SFDA guidelines and the applicable regulatory requirements.

2. The suitability of the protocol including the objectives of the study and the justification

of predictable risks and inconveniences weighed against the anticipated benefits for the

subjects and/or others, and the efficiency of its design.

3. To ensure the way of recruitment used as subjects and how appropriate information will

be given, and consent will be obtained.

4. Provision, if any, for compensation or treatment in the case of death or other loss or

injury of a subject, if attributable to a clinical trial, and details of any insurance or

indemnity (a source of legal and financial support) to cover the liability of the

investigator(s) and sponsor.

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 5. The acceptability of proposed amendments to the protocol that are likely to affect the

safety of the clinical trial subjects or to control the conduct of the trial.

6. To ensure that the investigator should promptly report to the IRB in case of:

 Deviations from, or changes of, the protocol to eliminate immediate hazards to the

trial subjects.

 Changes increasing the risk to subjects and/or affecting significantly the conduct of

the trial.

 All adverse drug reactions (ADRs) that are both serious and unexpected.

 New information that may affect adversely the safety of the subjects or the conduct

of the trial.

Responsibility of the Project Monitor

1. Assessment of the trial site

The monitor should assess the trial site prior to the clinical trial to ensure that the

facilities (including laboratories, equipment and staff) are adequate, and that an

adequate number of trial subjects is likely to be available for the duration of the trial.

The monitor should also assess the trial site during and after the trial to ensure that the

investigator complies with the protocol and that data are handled in accordance with

the predetermined set of standard operating procedures (SOP).

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2. Staff education and compliance

The monitor should ensure that all staff assisting the investigator in the trial have been

adequately informed about and will comply with the details of the trial protocol.

3. Data management

The monitor should assist the investigator in reporting the data and results of the trial to

the sponsor, e.g. by providing guidance on correct procedures for completion of case-

report forms (CRFs), and by verifying the accuracy of data obtained.

4. Case-report forms

The monitor is responsible for ensuring that all case-report forms (CRFs) are correctly

filled out in accordance with original observations. Any errors or omissions should be

clarified with the investigator, corrected, and explained on the CRF. Procedures should

be established for the investigator’s certification of the accuracy of CRFs by a signature,

initials or similar method. All procedures for ensuring accuracy of CRFs must be

maintained throughout the course of the clinical trial.

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5. Investigational product

The monitor should confirm that procedures for the storage, dispensing, and return of

investigational product(s) are safe, adequate, and properly documented in accordance

with local regulations and the trial protocol.

6. Communication

The monitor should facilitate communication between the investigator and sponsor. The

monitor (or some other responsible person designated by the sponsor and known to the

investigator) should be available to the investigator at all times for reporting of adverse

events or consultation on other trial-related matters.

7. Notification of the trial or submission to the drug regulatory authority

The monitor should assist the investigator in notifying the drug regulatory authority of

the clinical trial and submitting any necessary documentation.

8. Reports

The monitor should submit a written monitor report to the sponsor after each site visit

and after all relevant telephone calls, letters and other contacts with the investigator.

The report should include details of the findings and any actions taken and should
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 include a summary of what the monitor reviewed and the monitor's statements

concerning the significant findings/facts, deviations and deficiencies, conclusions,

actions taken or to be taken, and/or actions recommended to secure compliance.

Monitor is the key element that keeps the research projects on-track, on-time and within

budget. Monitors begins early in the project with planning and ends late in the project with

post-implementation review, having a thorough involvement of each step in the process.

Research projects may be audited or reviewed while the project is in progress. The main

difference between monitor and auditor is that auditor is independent of, and separate from

routine monitoring or quality control functions, should also evaluate clinical trial conduct and

compliance with the protocol, a standard operating procedures (SOPs), GCP, and the

applicable regulatory requirements.

Formal audits are generally risk or compliance-based and management that will direct the

objectives of the audit. Each research project should be assessed for the appropriate level of

control needed: too much control is too time consuming, too little control is very risky. If a

research project control is not implemented correctly, the cost to the sponsor should be

clarified in terms of errors and fixes. To preserve the independence and value of the audit

function, the regulatory authorities (such as SFDA) should not routinely request the audit

reports. Applicable regulatory authorities may seek access to an audit report on a case-by-case

150
basis, when evidence of serious GCP noncompliance exists, or if there is a violation to the

international standards, to be subjected to legal proceedings.

Change in research plan is a normal and expected part of the research process. Changes can be

the result of necessary design modifications, methodology, differing site conditions, material

availability, sponsor-requested changes, and impacts from third parties. Hence documentation

is essential to the IRB, and regulatory authorities whether if it is inside or outside the

institution. From a regular point of view, the PI or CRM should submit a final or updated

records to show any changes that modifies the research process until the research life cycle is

getting completed.

Variance is a set of procedures explaining how official project documents can be changed.

Keep in mind that no deviations from, or changes of, the protocol should be initiated without

prior written IRB approval of an appropriate amendment, except when necessary to eliminate

immediate hazards to the subjects or when the change(s) involves only logistical or

administrative aspects of the trial.

If there is a change during the research process, the practicability of the research project

needs to be reassessed. If the changes accumulated, the objective of the research project

could not be predicted as planned in the original proposal. Tracking and controlling the

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research process is a fundamental process to conduct a research progress so as to stay within

time and budget frames already outlined at the commencement of the project.

Research project controlling should be established as an independent function in research

project management. It implements verification and controlling function during the processing

of a research project in order to reinforce the defined performance and formal goals and in

the meantime to ensure the protection of the rights and welfare of human subjects

participating in clinical trials. The tasks of research project controlling are also:

 the creation of infrastructure for all procurement for a research project.

 variance analyses and generate for potential project changes regulations.

 creation of transparency among the project parameters and review amendment.

 Follow-up for an appropriate project structure, project workflow organization, project

control and governance

Project controls is defined as process on how to do data gathering, management and analytical

processes used to predict, understand and constructively influence the time and cost

outcomes of a project or program. Project control is essential to the research project

management process to facilitate sub-processes for safety, quality, organizational, behavioral,

and communications management.

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Control systems are needed for cost, risk, quality, communication, time, change, procurement,

and human resources. In addition, auditors should consider how important the projects are to

the financial statements, how reliant the sponsors are on controls, and how many controls

exist. Auditors should review the development process and procedures for how they are

implemented. The process of development and the quality of the final product may also be

assessed if needed or requested. A sponsor may want the auditing firm to be involved

throughout the research process to catch problems earlier on so that they can be fixed more

easily. An auditor can serve as a controls consultant as part of the development of the

research team or as an independent auditor as part of an audit.

Reference:
Project/programme monitoring and evaluation (M&E) guide. International Federation of
Red Cross and Red Crescent Societies, Geneva, 2011.
www.ifrc.org/Global/.../monitoring/IFRC

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 Questions about Monitoring and Controlling

1. What is the correct definition of Monitoring and Controlling Process?

a. Monitoring and Controlling is the process to confirm that some tasks of the research project
that was approved by the IRB and regulatory authorities were for conduction should be within
scope only.
b. Monitoring and Controlling is the process encompasses comparing tangible performance with
any performance baseline and taking corrective action to get the desirable research.
c. Monitoring and Controlling process is continuous assessment throughout the life cycle of the
research project.
d. Monitoring and Controlling process aims to provide the Principal Investigator with early partial
information on the progress of the clinical research.

2. The research project controller is a key member of the project management team and in the following
tasks, EXCEPT:
a. To help define the project’s goals and objectives
b. To create and maintain a project’s budget and schedule
c. To recommend actions to improve the progress of the research
d. To analyze progress report against the financial schedule

3. Who is responsible in giving attention to variances, which are unacceptable, those that cannot be
tolerated, such as in case adverse drug reaction for an investigational drug?

a. Project Manager

b. Principal Investigator

c. Monitor

d. Sponsor

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4. Who is responsible for the ethical conduct of a research?
a. Principal Investigator
b. Clinical Research Project Manager
c. Monitor
d. Sponsor

5. Monitor should consider ensuring that the investigator should promptly report to the IRB the following
cases, EXCEPT:
a. Some adverse drug reactions (ADRs) those are unexpected.
b. Changes increasing the risk to subjects and / or affecting significantly the conduct of the trial.
c. Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial
subjects.
d. New information that may affect adversely the safety of the subjects or the conduct of the trial.

6. What responsibility of Monitor where they should assist the investigator in reporting the data and
results of the trial to the sponsor?
a. Case-report forms
b. Communication
c. Investigational product
d. Data Management

7. How long Case-report forms (CRFs) must be maintained?

a. Throughout the course of the clinical trial
b. Six months after the clinical trial
c. After the clinical trial
d. Before the approval of the research

155
8. Which among the below statements in the communication responsibility of a monitor is CORRECT?
a. Sponsor should facilitate communication between the Clinical Research Project Manager and
Monitor
b. Monitor should facilitate communication between the Investigator and Sponsor
c. Monitor should facilitate communication between the Clinical Research Project Manager and
Sponsor
d. NONE OF THE ABOVE

9. Which of the following best describe the monitor report?

a. Monitor report should be verbally discussed to the sponsor after every other site visit and includes
monitor’s statements concerning all findings only.

b. Monitor report should be written and submitted to the Investigator after each site visit and all
communications with the Sponsor, which includes the details of the findings and any action taken
and the summary of what the monitor reviewed and his statements concerning the significant
findings/facts, actions taken or to be taken and/or recommended actions to secure compliance.

c. Monitor report should be written and submitted to the Sponsor after each site visit and all
communications with the Investigator, which includes the details of the findings and any action
taken and the summary of what the monitor reviewed and his statements concerning the
significant findings/facts, actions taken or to be taken and/or recommended actions to secure
compliance.

d. ALL OF THE ABOVE

156
10. Who is known as the element that keeps the research projects on-track, on-time and within the
budget and part in the early and post-implementation review of the project?

a. Monitor

b. Sponsor

c. Investigator

d. Auditor

11. Applicable regulatory authorities may seek access to an audit report on case-by-case basis or on
the following circumstances, EXCEPT:

a. Presence of evidence of serious Good Clinical Practice non-compliance

b. Existence of violation of the International Standards

c. Events that would be subjected to legal proceedings

d. NONE OF THE ABOVE

12. The following conditions suggest change in research project plan, EXCEPT:
a. Differing site conditions
b. Material Availability
c. Convenience of the Investigator
d. Design Modifications

13. What is the most important requirement for any deviations from or changes of the protocol?

a. Prior approval of the Sponsor

b. Prior written approval of IRB

c. Prior verbal approval of IRB

d. Prior approval of the Monitor

157
14. Which of the below statements define Research Project Controlling?

a. Research project controlling should be established as an independent function in research project

management.

b. Tasks of research project controlling includes the creation of in infrastructure for all procurement
for a research project, variance analyses and generate for potential project changes regulations,
creation of transparency among the project parameters and review amendment and follow-up for
an appropriate project structure, project workflow organization, project control and governance.

c. Research Project Controlling implements verification and controlling during the processing of a
research project in order to reinforce the defined performance and formal goals and in the
meantime to ensure the protection of the rights and welfare of human subjects participating in
clinical trials.

d. ALL OF THE ABOVE

15. Who should perform the review of the development process and procedures for how they were
implemented and may serve as controls consultant as part of the development of the research
team?

a. Auditor

b. Monitor

c. Investigator

d. Clinical Research Project Manager

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 ANSWERS
1. c. Monitoring and Controlling process is continuous assessment throughout the life cycle of the
research project.
2. d. To analyze progress report against the financial schedule
3. a. Project Manager is responsible in giving attention to variances.
4. c. Monitor
5. a. Some adverse drug reactions (ADRs) those are unexpected.
6. d. Data Management
7. a. Throughout the course of the clinical trial
8. b. Monitor should facilitate communication between the Investigator and Sponsor
9. c. Monitor report should be written and submitted to the Sponsor after each site visit and all
communications with the Investigator.
10. a. Monitor.

11. d. Applicable regulatory authorities may seek access to an audit report on case-by-case basis,
when evidence of serious GCP noncompliance exist.

12. c. Convenience of the Investigator

13. b. The most important requirement for any deviations from or changes of the protocol is Prior
written approval of IRB

14. d. All are statements define Research Project Controlling.

15. a. Auditor should perform the review of the development process and procedures.

159
Chapter 5.
Closing
Research Project Manager

160
RESEARCH PROJECT CLOSING

Research closing is the process that include all final activities in the research project

management which mean that the research project is ending thereof. All technical and clinical

across all of the processes are completed. All administrative activities include the archiving of

the files and documentation are finished. It also includes the process of writing article(s) and

manuscript(s) and doing final touches. Final technical report to the sponsor, IRB and regulatory

authorities should be submitted during this phase.

Project closeout includes the following key elements:

1. Financial report showing that:

 All bills and final charges.

 Payment to vendors have been made.

 Payment to research team and research support team have been made.

 Completing, collecting, and archiving all research project records.

 Close all contract(s) including contract completion, early termination, or failure to be

performed; and to ensure that payment have been made (if any).

 Close all part-time contracts with research support team or personnel reassignment.

 Redistributing resources—staff, facilities, equipment, and automated systems.

 All equipment purchased during the research processes were received by the property

department (even if it is still in the PI research laboratory) as assets for the institution.
161
 Turnover of project deliverables to the property department to be assets to the

institution.

2. Submitting to the IRB the followings:

 Checklist showing the research study have been closed out.

 All subject’s signed informed consent form are filed.

 All adverse event follow-up is completed

 Investigational drug brochure are filed.

3. Sponsor:

 Checklist showing the research study have been closed out.

 All case report form (CRFs) are completed and send to sponsor.

 Study drug have been return to the sponsor.

 Final report has been made to the sponsor.

4. Writing manuscript

 Documenting the successes of the project.

 Documenting lessons learned.

 Planning for Post Implementation Review.

162
 5. Final remarks

 Giving credit to the research team through formal recognition and celebrating the

research project conclusion.

 Transfer successfully research outcome information for the use of future research

projects.

The minimum list of essential documents that has been developed for every phase during the

research processes. The various documents are grouped in three sections according to the

stage of the trial during which they will normally be generated:

 before the clinical phase of the trial commences,

 during the clinical conduct of the trial, and

 after completion or termination of the trial.

A description is given of the purpose of each document, and whether it should be filed in

either the investigational institution or sponsor files, or both. It is acceptable to combine some

of the documents, provided the individual elements are readily identifiable

Closing is the final phase in which gives the chance to capture and transfer successfully

research project information for the use of future research projects. Also included in closing

163
phase is the Post Implementation Review. This is a vital phase of the research project for the

project research team to learn from experiences and apply to future projects. Normally a post

implementation review consists of looking at things that went well and analyzing things that

went badly on the project to come up with lessons learned.

Put in mind that operational process is not similar to a project process. A project such as a

clinical research, should has a definite start and end date whereas, an operation process does

not have definite end date. Whether the project has been successful or is not, a project needs

to be closed! Although it is important to ensure that the research production is with the

desirable outcomes, it is normal to have negative expectation, or loose ends at the end of a

research project. The fact is there is no loose ends in research whether if the research

outcome is negative or positive.

Outcomes research is applied clinical and population based research that seeks to study and

optimize the end results of healthcare in terms of benefits to the patient and society. The

intent of ant particular research is to identify shortfalls in practice and to develop strategies to

improve care.

Outcomes research seeks to provide evidence about which interventions work best for which

types of patients and under what circumstances. However, the evaluation methodology of

outcomes research may include both experimental and non-experimental designs: further, the

"intervention" being evaluated is not limited to medications or new clinical procedures, but
164
may also include the provision of particular services or resources, or even the enforcing of

specific policies and regulations by legislative/financial bodies. Also, while traditional clinical

trials focus primarily on therapeutic efficacy and safety, outcomes research may consider

additional parameters such as cost, timeliness, convenience, geographical accessibility and

patient preferences. Consequently, the field is more multi-disciplinary, involving, in addition to

healthcare professionals and the manufacturers of medical devices or pharmaceuticals,

medical economists, sociologists, and public health researchers.

Clinical trial where the use of human as subjects are prone to adverse drug reaction or events

that could be endanger the health of the subjects, therefore it is important to ensure the

protection of the rights, safety, and well-being of human subjects involved in a trial. Efficient

monitoring, controlling, auditing, reviewing, approving, and providing continuing review of

trials is essential. “The Closing Process Group consists of those processes performed to

conclude all activities across all Project Management Process Groups to formally complete the

project, phase, or contractual obligations.” –A Guide to the Project Management Body of

Knowledge (PMBOK Guide) Fifth Edition.

165
References:
1. Project Close-Out Practices Guide
www2.cdc.gov/.../CDC_UP_Project_Close-Out_Practices_Guide.pd
2. Post Implementation Evaluation Report (PIER); Health and Human Services Agency,
Office of Systems Integration Project Management Office. August 2008
3. PROJECT MANAGEMENT GUIDELINE; SECTION 5 – PROJECT CLOSEOUT PHASE, 2006

166
 Research Study closeout “checklist”
Protocol ……………………
Sponsor ……………………..
Investigator …………………..
Date ……………

 Study documents file is completed

 Final report has been made to the IRB and the sponsor
 All case report forms (CRFs) are complete and have been submitted to the sponsor
 All CRFs correction / queries have been addressed
 Any patient diaries , etc. have been submitted, as required
 All adverse event follow-up is completed (if any)
 All source documentation is in order
 If not with study files , location of material is noted in the document file
 Study personnel form is complete
 Subjects' signed informed consent form are filed
 Drug dispensing and disposition forms are complete
 Study drug has been returned as per sponsor instructions
 All other study material (extra CRF, ETC.) have been returned to the sponsor
 Investigator brochure is filed with other study materials
 All study material are filed together as per archival procedures
 Location of materials is noted in site records
 All work order are completed
 All outstanding commitments are resolved
 All payment to vendors have been made
 All payment to research support team have been made
 All payment to research team have been made
 Financial report is closed

167
 168
Name of Research Institution
RESEARCH GRANT FINANCIAL REPORT
Protocol No: Res protocol No 1 P.I. : Dr. Xxxx Yyyy Zzzz
Title: Title of the Research Project Duration: 12 Months
APPROVED BUDGET ACTUAL DISBURSEMENTS
INV.NO / CASH FROM CASH DIRECT Special BALANCE
BUDGET ITEMS AMOUNT REF # DATE DATE PAYEE DESCRIPTION TOTAL
RECEIPT NO. ADVANCE ADVANCE PAYMENT Purchase
Principal Investigator 40,000 40,000
Sub-Investigator(s) 100,000 100,000
Scientific Consultant 25,000 Ref/fin/12 01/06/2016 Dr John Scientific consultaion 25,000 0
Biostatistician 15,000 Ref/fin/14 15/06/2016 Dr Hasan 1st Payment 5,000 10,000
Research Nurse 40,000 Ref/fin/17 01/09/2016 XX YY ZZ Payment for 6 nurses 12,500 27,500
150 patients (total of 250vists)
Technician 20,000 Ref/fin/15 01/08/2016 150 patints x50 7,500 12,500
Interviewer 48,000 Ref/fin/21 01/10/2016 150*12*10 18000 30,000
SUB-TOTAL 288,000 - - - 68,000 220,000
Continuous Gluco-monitor 200,000 Ref/fin/3 01/03/2016 Glu/M 06 01/04/2016 X Y Gluco manufacture SPR # 1234 200,000 0
Laptops 10,000 Ref/fin/5 01/017/2016LP/221 01/03/2016 Lap top and devices SPR # 1235 8500 1,500
Glucometers Free
SUB-TOTAL 210,000 - - - 208,500 1,500
Strips 240,000 Ref/fin/2 01/03/2016 Glu/M 05 01/04/2016 X Y Gluco manufacture SPR# 1233 120,000 120,000
SUB-TOTAL 240,000 - - - 120,000 120,000
Travelling 30,000 Ref/fin/6 12/04/2016 12400 17,600
Accommodation 20,000 Ref/fin/7 15/04/2016 6500 13,500
Advertisement 10,000 Ref/fin/13 14/06/2016 8000 2,000
Publication cost 10,000 10,000
SUB-TOTAL 70,000 - - - 26,900 43,100
Miscellanous 50,000 31900 18,100
Transportaion Ref/fin/9 15/05/2016 3400
Shipment Ref/fin/18 22/08/2016 1500
Training Ref/fin/21 27/09/2016 15,000
Meeting Ref/fin/23 03/10/2016 12000
SUB-TOTAL 50,000 - - - 63,800 18,100
GRAND TOTAL 858,000 487,200 402,700
 Work Breakdown Structure for writing a manuscript 1/2
manuscript title
authors and affiliations
Level
1 Abstract
1.1 Introduction
1.2 Method
1.3 Result
1.4 Conclusion

2 Introdcution
2.1 Project Summary
2.2 Background information
2.2.1 Reason for conducting Research
2.2.2 Current Situation
2.2.3 Definition of Key Concept
2.3 Litrature Review
2.3.1 Problem that basis of the Project
2.3.2 Cause of the problem
2.3.3 Possible Solution
2.4 Study Goals
2.4.1 Aims
2.4.2 Objective
2.4.3 Purpose

3 Methodology
3.1 Study Design and Participant
3.1.1 Type of the Study
3.1.2 Population
3.1.2.1 Participant Recruitment
3.1.2.2 inclusion criteria
3.1.2.3 exclusion criteria

169
 Work Breakdown Structure for writing a manuscript 2/2

3.2 Study outcomes

3.3 Study instrument
3.3.1 Observations
3.3.2 Instrument to collect Information
3.3.3 Laboratory investigation
3.3.4 Equipment needed
3.4 Data Collection
3.5 Etical Considerations
3.6 Data analysis

4 Results
4..1 Participants demographic characteristics
4.2 Outcomes
4.2.1 tables
4.2.2 figures and graphs

5 Discussion
5.1 Summary of results
5.2 comparison with similar literatures
5.3 strengths and limitations
5.4 implication in practice
5.5 recommendations

6 conclusion
7 Acknowledgments
8 conflect of intrest
9 source of funding
10 references
10.1 primary refrences
10.2 websites
10.3 books
11 appendices

170

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