This Retrospective 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 required language which must be inserted into your protocol at
the indicated location.
Residents or students, who need assistance with retrospective protocol development
and discussion of funding options, please contact the GRMERC Research Department
at 616-732-6223, or by email at research@grmerc.net. For others, contact the Spectrum
Health research department for assistance at 616-391-3050.
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.
When applying for funding, the choice of words in the title is particularly important because it influences
the decision on which study section (or review group) will receive the protocol.
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.
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 W ITHDRAWAL ................................................................................... 4
3.2.1 INCLUSION CRITERIA................................................................................................................... 4
3.2.2 EXCLUSION CRITERIA ................................................................................................................. 4
3.3
STUDY PROCEDURES.................................................................................................................. 4
3.4
STATISTICAL PLAN ....................................................................................................................... 4
3.4.1
3.4.2
4
SAMPLE SIZE DETERMINATION .................................................................................................... 4
STATISTICAL METHODS ............................................................................................................... 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
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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 Spectrum Health research requirements. The following text is required for all
retrospective protocols submitted through Spectrum Health:
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)
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.
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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.).
3.2.2 Exclusion Criteria
Create a list of criteria that would exclude a subject from the study.
3.3 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. The time period for the charts to be reviewed, as well as the
institutions from which the records will be acquired, should also be listed in this
section.
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 Data Handling and Record Keeping
4.1 Confidentiality
The following text is required for all retrospective protocols submitted through
Spectrum Health:
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). Those regulations require that the Spectrum Health Privacy Board 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
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For retrospective studies, summarize the record retention plan applicable to the
study. The following sample language is appropriate:
The correlation tool will be destroyed at the completion of the study in accordance
with the Spectrum Health documentation destruction policy.
4.3 Regulatory Binder
The investigators are required to maintain a regulatory binder containing all
information pertinent to the study. Please refer to [SH website link to
regulatory binder info] for more information pertaining to required elements
for a regulatory binder for a retrospective study. The following text is required for all
retrospective protocols submitted through Spectrum Health:
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,
and all other information pertinent to this study.
5 Study Auditing and Inspecting
The following text is required for all retrospective protocols submitted through
Spectrum Health:
The investigator will permit study-related monitoring, audits, and inspections by the
Spectrum Health IRB, the sponsor, government regulatory bodies, and Spectrum
Health research compliance and quality assurance groups 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 Spectrum Health
compliance and quality assurance offices.
6 Budget
Resident and medical student researchers please contact the GRMERC
Research Department (616-732-6223 or research@grmerc.net) for assistance
in securing funding for the project.
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 required for all retrospective
protocols submitted through Spectrum Health:
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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 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.
9 Attachments
This section should contain all pertinent documents associated with the
management of the study (i.e., waiver of authorization/consent, data sheet, etc).
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