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Protocol and Its Components-1

The document outlines the essential components and rationale for a clinical research protocol, which serves as a comprehensive study plan for clinical trials. It details the necessary sections including general information, background, trial objectives, design, subject selection, treatment, safety and efficacy assessments, statistical methods, ethical considerations, data handling, financing, and references. The protocol is crucial for clarifying research questions, ensuring ethical conduct, and guiding the research team throughout the trial process.

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18 views19 pages

Protocol and Its Components-1

The document outlines the essential components and rationale for a clinical research protocol, which serves as a comprehensive study plan for clinical trials. It details the necessary sections including general information, background, trial objectives, design, subject selection, treatment, safety and efficacy assessments, statistical methods, ethical considerations, data handling, financing, and references. The protocol is crucial for clarifying research questions, ensuring ethical conduct, and guiding the research team throughout the trial process.

Uploaded by

tambolit2
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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PROTOCOL

INTRODUCTION

• Protocol is a document that describes the background, rationale, objectives,


design, methodology, statistical considerations, and organization of a clinical
research project.
• The protocol contains a study plan on which the clinical trial is based.
WHY A PROTOCOL IS NEEDED?

• To clarify the research question.


• To compile existing knowledge.
• To formulate a hypothesis.
• To decide about the study design.
• To clarify ethical consideration.
• To have a guideline for the research team.
COMPONENTS OF THE PROTOCOL
1.GENERAL INFORMATION

• Details of the protocol : Protocol title, protocol identifying number, date, and any
amendments.
• Details of the sponsor, investigators, and sponsor's medical expert.
• Details of the persons authorized to sign the protocol.
• Details of the qualified physician who is responsible for trial-site related medical
decisions.
• Details of the clinical laboratories and other medical and technical departments and
institutions involved in the trial.
2.BACKGROUND INFORMATION

• Details of the investigational products.


• Summary of findings from non-clinical studies and clinical trials.
• Summary of the known and potential risks and benefits to human subjects.
• Description of dosage and dosage regimen.
• Statement that trial is conducted according to GCP.
• Description of the population to be studied.
• References to literature and data that are relevant to the trial.
3.TRIAL OBJECTIVE AND PURPOSE

• A detailed descriptions of the objectives and the purpose of the trial.


4.TRIAL DESIGN

Includes-
• Primary and secondary endpoints.
• Design of the study (double-blind, placebo controlled, etc.).
• Measures taken to minimize bias (randomization, blinding).
• Study treatments or interventions.
• Expected duration of subject participation (what is done and when).
• Stopping rules or discontinuation criteria.
5.SELECTION AND WITHDRAWAL OF SUBJECTS

• Include subjects inclusion criteria.


• Include subjects exclusion criteria.
• Include subjects withdrawal criteria.
6.TREATMENT OF SUBJECTS

• The treatment to be administered, including the name of all the products,


dose, the dosing schedule, the route/mode of administration and the
treatment period.
• Medication/ treatment permitted and not permitted before and/or during
the trial.
7.ASSESSMENT OF SAFETY

• Specification of safety parameters.


• The methods and timing for assessing, recording, and analyzing safety
parameters.
• Procedure for eliciting reports of and recording and reporting adverse event
and, inter current illnesses.
8.ASSESSMENT OF EFFICACY

• Specification of the efficacy parameters.


• Methods and timing for assessing, recording, and analyzing of efficacy
parameters.
9.STATISTICS

• A description of Statistical methods.


• Criteria for the termination of trial.
• Level of significance to be used.
• Procedure for accounting for missing, unused,and spurious data.
• Procedures for reporting any deviation.
• Selection of subjects to be included in the analyses.
10.ETHICS

• The research protocol should also describe the ethical considerations


relating to the study.
• It should not only be limited to providing ethics approval, but also the issues
that are likely to raise ethical concerns.
• Additionally, the ethics section must also describe how the investigator(s)
plan to obtain informed consent from the research participants.
11.DIRECT ACCESS TO SOURCE DATA/DOCUMENTS

• Sponsor ensures that it is specified in the protocol or other written


agreement that the investigator will permit trial related monitoring, audits,
IEC review, and regulatory inspection by providing direct access to source
data/documents.
12.DATA HANDLING AND RECORD KEEPING

• Describe procedures for data collection and recording.


• Detail methods implemented to ensure validity and quality of data.
• Confidentiality.
• How long and where will the data from the study be kept and who will be
responsible for its safekeeping.
13.FINANCING AND INSURANCE

It must include :
• Budget, financial aspects
• Sources of economic support
• Subject payments
• Reimbursement to team members
• Insurance details of study subjects
14.PROJECT TIMETABLE /FLOWCHART.

15.REFERENCES.

• References must be cited for any statement that can be attributed to a specific
source.
• They should be numbered consecutively throughout the protocol.

16.SUPPLEMENTS /APPENDICES.
• Based on the protocol, relevant appendices as elaborated should be attached:
- Patient consent form
- Data collection forms (case report form)
- Summary of product (test, procedure characteristics)
-Patient information sheet
THANK YOU

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