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Protocol Template: Retrospective Descriptive Study

This document provides a template for a retrospective descriptive study protocol. It includes sections for the title, investigators, table of contents, abbreviations, background/rationale, objectives, investigation plan, study procedures, statistical considerations, data collection/management, recruitment, consent, publication plans, and references. The template can be used to develop a protocol for a retrospective study using existing medical records and specimens to study outcomes, prevalence, or complications of a particular condition.

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overmega
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© © All Rights Reserved
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47 views

Protocol Template: Retrospective Descriptive Study

This document provides a template for a retrospective descriptive study protocol. It includes sections for the title, investigators, table of contents, abbreviations, background/rationale, objectives, investigation plan, study procedures, statistical considerations, data collection/management, recruitment, consent, publication plans, and references. The template can be used to develop a protocol for a retrospective study using existing medical records and specimens to study outcomes, prevalence, or complications of a particular condition.

Uploaded by

overmega
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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PROTOCOL TEMPLATE: RETROSPECTIVE DESCRIPTIVE STUDY

Sections that are not applicable can be deleted.

Complete Title:
Short Title:
Drug or Device Name(s):
FDA IND/IDE (if applicable):
Sponsor:
Protocol Date:
Amendment 1 Date:
Amendment 2 Date:
Amendment 3 Date:
Amendment 4 Date:

Sponsor (IND or IDE holder, if applicable)


Sponsor Name
Address
City, State, Zip
Country

Study Principal Investigator (if multicenter study with UNC PI responsible)


Office Address
City, ST, ZIP
Phone XXX-XXX-XXXX
email: [email protected]

Retrospective _descriptive protocol template_Draft_29AUG2016


EXAMPLE: Protocol Signature page for Multicenter research where the PI at UNC is the overall PI.

PROTOCOL TITLE: XXXXXX

Short Title: XXXXX

Lead Investigator:

XXX XXXX, M.D.

University of North Carolina at Chapel Hill

Protocol Version: XX.XX

Version Date: XXX XX, 201X

I confirm that I have read this protocol and understand it.

Principal Investigator Name:

Principal Investigator Signature:

Date:

Retrospective _descriptive protocol template_Draft_29AUG2016


TABLE OF CONTENTS

Table of Contents..................................................................... 0
Abbreviations and Definitions of Terms.....................................0
Protocol Synopsis....................................................................0
1 BACKGROUND AND RATIONALE.................................................................................0
2 STUDY OBJECTIVES..................................................................................................... 0
3 INVESTIGATIONAL PLAN.............................................................................................. 0
4 STUDY PROCEDURES................................................................................................... 0
5 STATISTICAL CONSIDERATIONS...................................................................................0
6 DATA COLLECTION AND MANAGEMENT.......................................................................0
7 RECRUITMENT STRATEGY............................................................................................ 0
8 CONSENT PROCESS..................................................................................................... 0
9 PUBLICATION............................................................................................................... 0
10 REFERENCES............................................................................................................... 0
Appendix................................................................................. 0

Retrospective _descriptive protocol template_Draft_29AUG2016


ABBREVIATIONS AND DEFINITIONS OF TERMS
Insert and delete terms as relevant

Abbreviation Definition

Retrospective _descriptive protocol template_Draft_29AUG2016


1 BACKGROUND AND RATIONALE
(Can refer to the grant proposal.)
1.1 Introduction
Describe the setting and rationale for the study.
1.2 Potential Risks and Benefits

1.3 Relevant Literature and Data


Include literature and data that provide background for the study and established validity for scales
and evaluation tools.

2 STUDY OBJECTIVE
Example: “The purpose of the study is to determine the (outcomes, prevalence, complications) of ….”
2.1 Primary Objective
2.2 Secondary Objective

3 INVESTIGATIONAL PLAN (brief overview)


3.1 Study Design
Type of design: (cohort study, descriptive, case control, etc.)
3.2 Study Duration, Enrollment and Number of Subjects
3.3 Study Population
-Inclusion and Exclusion Criteria

4 STUDY PROCEDURES (what will be done)


Describe review of existing medical records and/or use of existing biological specimens.
4.1 Sources
4.2 Data elements abstracted

Retrospective _descriptive protocol template_Draft_29AUG2016


5 STATISTICAL CONSIDERATION
Ensure that data is coded in such a way that it can be readily analyzed and ensure that sample size
will be appropriate.
5.1 Primary Endpoint
5.2 Secondary Endpoint
5.3 Statistical Methods
5.4 Measures to Avoid Bias
5.5 Sample Size and Power
- Sample size should be justified based on study objectives.
- If sample size is limited, determine the effective size that you can reasonably expect to detect.

6 DATA COLLECTION AND MANAGMENT


-Case report forms?
-How will confidentiality be maintained?
-Anonymization, de-identification or destruction after publication?

7 RECRUITMENT STRATEGY
8 CONSENT PROCESS
Describe the procedure that will be used to obtain informed consent/HIPAA authorization and assent
(if applicable).
-Who will obtain consent/assent?
-Where will consent /assent process take place?
-How will investigator assure that subjects comprehend the nature of the study, procedures, the risks
and benefits?
9 PLANS FOR PUBLICATION
10 REFERNECES
11 APPENDIX

Retrospective _descriptive protocol template_Draft_29AUG2016

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