retrospective protocol template

7/30/2019 Retrospective Protocol Template

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This Retrospective Protocol Template serves as a guide to assist you in thedevelopment of your protocol. NOT ALL COMPONENTS WILL BE APPLICABLE TOYOUR 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 atthe indicated location.

Residents or students, who need assistance with retrospective protocol developmentand discussion of funding options, please contact the GRMERC Research Departmentat 616-732-6223, or by email at [email protected]. For others, contact the SpectrumHealth 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 thecontent and design of the study.

When applying for funding, the choice of words in the title is particularly important because it influencesthe 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 Incidenceof 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 programsInstitutions: Insert the Name of Institution the Author(s) Represent; use

footnotes to link authors with institutions

CorrespondingAuthor:

Insert the Full Name of Investigator and Degree(s)Insert Department NameInsert AddressInsert Phone; Insert FaxInsert Email

CONFIDENTIALThis 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.

Current Version Date:Previous IRB Approved Version Dates:
mailto:[email protected]:[email protected]


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Table of Contents(***Notice*** Table of Contents willupdate automatically)

1.1 STUDY DESIGN......................................................................................................................................................3

1.1.1 General Design............................................................................................................................................ 3

1.1.2 Primary Outcome Variable..........................................................................................................................3

1.1.3 Secondary Outcome Variables.....................................................................................................................31.2 SUBJECT SELECTIONAND WITHDRAWAL.............................................................................................................4

1.2.1 Inclusion Criteria.........................................................................................................................................4

1.2.2 Exclusion Criteria........................ .............. .............. ............... .............. .............. .............. .............. ............. 4

1.3 STUDY PROCEDURES.............................................................................................................................................4

1.4 STATISTICAL PLAN............................................................................................................................................... 4

1.4.1 Sample Size Determination............. .............. .............. .............. ............... .............. .............. .............. .......... 4

1.4.2 Statistical Methods.......................................................................................................................................4

1.5 REGULATORY BINDER.......................................................................................................................................... 5

Version Date Page 2 of 6


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1 Introduction/SignificanceThe introduction should open with remarks that state this document is a clinicalresearch 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 allretrospective protocols submitted through Spectrum Health:

This study is to be conducted according to US and international standards of GoodClinical Practice (FDA Title 21 part 312 and International Conference on Harmonizationguidelines), applicable government regulations and Institutional research policies andprocedures.

The remaining paragraphs in this section should contain a background discussion ofstudies relevant to the research question(s). References should be cited throughout.The cited literature will be included in the Reference section.

2 Study ObjectivesDescribe the specific aims for the study.

This should include both primary and any secondary objectives, as illustrated:Primary ObjectiveTo assess the efficacy of XXXX on decreasing infarct size as measured by Sestamibiscanning.

Secondary Objective

To assess the safety and tolerability of two doses of XXXX in subjects with acutemyocardial infarction.

3 Patients and Methods

1.1 Study Design

1.1.1 General Design

Describe the study design of the study (e.g. case series, case-control, retrospectivecohort, nested case-control)

1.1.2 PrimaryOutcomeVariableDescribe the primary outcome variable to be analyzed in the study (e.g. could belength of stay or mortality, depending upon the primary objective of the study).

1.1.3 SecondaryOutcomeVariables

Describe any secondary outcome variables to be analyzed in the study.



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1.2 Subject Selection and Withdrawal

1.2.1 InclusionCriteria

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.).

1.2.2 ExclusionCriteria

Create a list of criteria that would exclude a subject from the study.

1.3 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 listedon your data sheet. The time period for the charts to be reviewed, as well as theinstitutions from which the records will be acquired, should also be listed in thissection.

1.4 Statistical Plan

1.4.1 SampleSize Determination

Describe how the sample size was determined for this study. The sample sizeshould be based upon the primary outcome variable. If the authors havedetermined that a sample size estimation was not necessary, please provide therationale.

1.4.2 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 theanalysis of the primary outcome variable. Define the tests for the analysis of thesecondary outcome variables. Set the level of significance, ie, significance will beassessed at p < 0.05. If no statistical tests are planned, denote that only summarystatistics 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 tothe requirements of the Health Insurance Portability and Accountability Act of 1996(HIPAA). Those regulations require that the Spectrum Health Privacy Board grantapproval of an authorization to collect the Protected Health Information (PHI) withoutwritten consent from the participant for research purposes.



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4.2 Records Retention

For retrospective studies, summarize the record retention plan applicable to thestudy. The following sample language is appropriate:

The correlation tool will be destroyed at the completion of the study in accordancewith the Spectrum Health documentation destruction policy.

1.5 Regulatory Binder

The investigators are required to maintain a regulatory binder containing all

information pertinent to the study. Please refer to [SH website link toregulatory binder info]for more information pertaining to required elementsfor a regulatory binder for a retrospective study. The following text is required for allretrospective protocols submitted through Spectrum Health:

A regulatory binder will be maintained for this study. This will include items such asthis 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 InspectingThe following text is required for all retrospective protocols submitted throughSpectrum Health:

The investigator will permit study-related monitoring, audits, and inspections by theSpectrum Health IRB, the sponsor, government regulatory bodies, and Spectrum

Health research compliance and quality assurance groups of all study relateddocuments (e.g. source documents, regulatory documents, data collectioninstruments, study data etc.).

Participation as an investigator in this study implies acceptance of potentialinspection by government regulatory authorities and applicable Spectrum Healthcompliance and quality assurance offices.

6 Budget

Resident and medical student researchers please contact the GRMERCResearch Department (616-732-6223 [email protected]) for assistancein securing funding for the project.

This section should provide a brief summary of the expenses estimated for thestudy, as well as the projected funding source.

mailto:[email protected]:[email protected]


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7 Publication PlanDescribe the plan for publication. The following text is required for all retrospective

protocols submitted through Spectrum Health:

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. Anabstract of the completed study, after input from all of the authors, will be submittedto (meeting of choice, date of meeting). A manuscript of the study, having receivedinput from all of the authors, is tentatively scheduled for submission on (date).

8 ReferencesThis is the literature cited section for any information referenced in the protocol. Itshould 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 themanagement of the study (i.e., waiver of authorization/consent, data sheet, etc).


retrospective protocol template

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