Human Research Protection Program
Good Clinical Practice
Guidance for Investigators
Research Protocol Template:
Biomedical Sample #2
GUIDANCE FOR INVESTIGATORS
Biomedical Research Template
This Protocol Template serves as a guide to assist you in the development of your protocol. NOT ALL
COMPONENTS WILL BE APPLICABLE TO YOUR STUDY.
 Items in RED/italicized are instructional and should be populated or deleted.
 Items in PURPLE are recommended language that should be inserted into your protocol at the
indicated location.
Insert Title of Protocol
The title should be descriptive and concise. It provides the first impression and a lasting reminder of the
content and design of the study.
Example title:
A Comparison of Open, Hand-assisted and Laparoscopic Bowel Resection with Regards to the Incidence
of Small Bowel Obstruction and Ventral Hernia
Authors:
Insert the Full Name of Each Investigator and Degree(s)
Program:
Insert the Name of Program the Author(s) Represent; use footnotes to link
authors with programs
Insert the Name of Institution the Author(s) Represent; use footnotes to link
authors with institutions
Insert the Full Name of Investigator and Degree(s)
Insert Department Name
Insert Address
Insert Phone; Insert Fax
Insert Email
Institutions:
Corresponding
Author:
Current Version Date:
Previous IRB Approved Version Dates:
CONFIDENTIAL
This document is confidential and the property of individual. No part of it may be transmitted,
reproduced, published, or used by other persons without prior written authorization from the
author.
SEQuR-Guidance For Investigators - Protocol Template: Biomedical Research – Sample #2
Page 1 of 5
Effective Date: 05/01/2013
Supersedes NA
Human Research Protection Program
Good Clinical Practice
Guidance for Investigators
Research Protocol Template:
Biomedical Sample #2
Table of Contents
(***Notice*** Table of Contents will update automatically)
1
INTRODUCTION/SIGNIFICANCE ............................................................................................... 3
2
STUDY OBJECTIVES ...................................................................................................................... 3
3
PATIENTS AND METHODS ........................................................................................................... 3
3.1
STUDY DESIGN ............................................................................................................................ 3
3.1.1 GENERAL DESIGN ...................................................................................................................... 3
3.1.2 PRIMARY OUTCOME VARIABLE ................................................................................................... 3
3.1.3 SECONDARY OUTCOME VARIABLES ............................................................................................ 3
3.2
SUBJECT SELECTION AND WITHDRAWAL ....................................................................... 3
3.2.1 INCLUSION CRITERIA.................................................................................................................. 3
3.2.2 EXCLUSION CRITERIA................................................................................................................. 4
3.3
STUDY PROCEDURES .............................................................................................................. 4
3.4
STATISTICAL PLAN ................................................................................................................. 4
3.4.1 SAMPLE SIZE DETERMINATION ................................................................................................... 4
3.4.2 STATISTICAL METHODS .............................................................................................................. 4
4
DATA HANDLING AND RECORD KEEPING ............................................................................ 4
4.1
4.2
4.3
CONFIDENTIALITY ....................................................................................................................... 4
RECORDS RETENTION .................................................................................................................. 5
REGULATORY BINDER .................................................................................................................. 5
5
AUDITING AND INSPECTING ...................................................................................................... 5
6
BUDGET ............................................................................................................................................. 5
7
PUBLICATION PLAN ...................................................................................................................... 6
8
REFERENCES ................................................................................................................................... 6
9
ATTACHMENTS............................................................................................................................... 6
SEQuR-Guidance For Investigators - Protocol Template: Biomedical Research – Sample #2
Page 2 of 5
Effective Date: 05/01/2013
Supersedes NA
Human Research Protection Program
Good Clinical Practice
Guidance for Investigators
Research Protocol Template:
Biomedical Sample #2
1
Introduction/Significance
The introduction should open with remarks that state this document is a clinical research protocol and
the described study will be conducted in compliance with the protocol, Good Clinical Practices standards
and associated Federal regulations, and all applicable MMC IRB research requirements. The following
text is recommended for all research protocols:
This study is to be conducted according to US and international standards of Good Clinical Practice (FDA
Title 21 part 312 and International Conference on Harmonization guidelines), applicable government
regulations and Institutional research policies and procedures.
The remaining paragraphs in this section should contain a background discussion of studies relevant to
the research question(s). References should be cited throughout. The cited literature will be included in
the Reference section.
2 Study Objectives
Describe the specific aims for the study.
This should include both primary and any secondary objectives, as illustrated:
Primary Objective
To assess the efficacy of XXXX on decreasing infarct size as measured by Sestamibi scanning.
Secondary Objective
To assess the safety and tolerability of two doses of XXXX in subjects with acute myocardial infarction.
3
Patients and Methods
3.1
Study Design
3.1.1 General Design
Describe the study design of the study (e.g. case series, case-control, retrospective cohort, nested
case-control, prospective cohort)
3.1.2
Primary Outcome Variable
Describe the primary outcome variable to be analyzed in the study (e.g. could be length of stay or
mortality, depending upon the primary objective of the study).
3.1.3
Secondary Outcome Variables
Describe any secondary outcome variables to be analyzed in the study.
3.2
Subject Selection and Withdrawal
3.2.1
Inclusion Criteria
Create a list of criteria subjects must meet to be eligible for study inclusion (e.g. age, gender,
target disease, concomitant disease if required, etc.).
SEQuR-Guidance For Investigators - Protocol Template: Biomedical Research – Sample #2
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Effective Date: 05/01/2013
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Human Research Protection Program
Good Clinical Practice
Guidance for Investigators
Research Protocol Template:
Biomedical Sample #2
3.2.2
3.3
Exclusion Criteria
Create a list of criteria that would exclude a subject from the study.
Study Procedures
In this section, describe what data will be accessed, and how they will be obtained. All variables to
be extracted must be identified. The variables should all be listed on your data sheet and included in
this protocol. The time period for the charts to be reviewed, as well as the institutions, repository,
database from which the records will be acquired, should also be listed in this section. If you do not
have access to these records by your mentor or employer you must provide a letter of support with
this protocol from the division/department.
3.4
Statistical Plan
3.4.1
Sample Size Determination
Describe how the sample size was determined for this study. The sample size should be based upon
the primary outcome variable. If the authors have determined that a sample size estimation was
not necessary, please provide the rationale.
3.4.2
Statistical Methods
Describe how the data will be summarized (ie, mean+SD, medians and ranges, percentages with
95% confidence intervals, etc). Identify the statistical test for the analysis of the primary outcome
variable. Define the tests for the analysis of the secondary outcome variables. Set the level of
significance, ie, significance will be assessed at p < 0.05. If no statistical tests are planned, denote
that only summary statistics will be used.
4
4.1
Data Handling and Record Keeping
Confidentiality
The following text is required for all protocols submitted:
Information about study subjects will be kept confidential and managed according to the requirements
of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
Add the following if you have received a waiver of Informed Consent:
Those regulations require that the MMC IRB grant approval of an authorization to collect the
Protected Health Information (PHI) without written consent from the participant for research
purposes.
4.2
Records Retention
Summarize the record retention plan applicable to the study. The following sample language is
appropriate for retrospective studies:
The correlation tool/ key linking data to PHI will be destroyed at the completion of the study in
accordance with the MMC documentation destruction policy.
SEQuR-Guidance For Investigators - Protocol Template: Biomedical Research – Sample #2
Page 4 of 5
Effective Date: 05/01/2013
Supersedes NA
Human Research Protection Program
Good Clinical Practice
Guidance for Investigators
Research Protocol Template:
Biomedical Sample #2
4.3
Regulatory Binder
The investigators are required to maintain a regulatory binder containing all information pertinent
to the study. This may be in paper or electronic format accessible for review. Please refer to
MMCRI/HRPP SECuR website link for regulatory binder info. The following text is recommended
for all retrospective protocols:
A regulatory binder will be maintained for this study. This will include items such as this protocol,
the letter of approval from the IRB, the Waiver of Authorization form, communication with the IRB,
documentation of investigator training, delegation of responsibilities for research staff and all other
information pertinent to this study.
5
Study Auditing and Inspecting
The following text is recommended for all study protocols:
The investigator will permit study-related monitoring, audits, and inspections by the MMC IRB,
the sponsor (if applicable), government regulatory bodies, and MMC IRB research compliance and
quality assurance (SEQuR) of all study related documents (e.g. source documents, regulatory
documents, data collection instruments, study data etc.).
Participation as an investigator in this study implies acceptance of potential inspection by
government regulatory authorities and applicable MMC IRB compliance and quality assurance
offices.
6
Budget
This section should provide a brief summary of the expenses estimated for the study, as well as the
projected funding source.
7
Publication Plan
Describe the plan for publication. The following text is recommended for all protocols:
Findings will be shared and discussed with all of the investigators for the study. An estimated
timeline for creation of an abstract will be defined at that time. An abstract of the completed study,
after input from all of the authors, will be submitted to (meeting of choice, date of meeting). A
manuscript of the study, having received input from all of the authors, is tentatively scheduled for
submission on (date).
8
9
References
This is the literature cited section for any information referenced in the protocol. It should be
organized as found in a medical journal such as JAMA or the NEJM.
Attachments
This section should contain all pertinent documents associated with the management of the study
(i.e., waiver of authorization/consent, data sheet, etc).
SEQuR-Guidance For Investigators - Protocol Template: Biomedical Research – Sample #2
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Effective Date: 05/01/2013
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