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: Program: Institutions: Corresponding Author:

Insert the Full Name of Each Investigator and Degree(s) 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

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) 1.1 STUDY DESIGN......................................................................................................................................................3 1.1.1 General Design............................................................................................................................................ 3 1.1.2 Primary Outcome Variable.......................................................................................................................... 3 1.1.3 Secondary Outcome Variables.....................................................................................................................3 1.2 SUBJECT SELECTION AND 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

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

1.1 Study Design
1.1.1 General Design
Describe the study design of the study (e.g. case series, case-control, retrospective cohort, nested case-control)

1.1.2 PrimaryOutcomeVariable
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).

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

Version Date

Page 3 of 6

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 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.

1.4 Statistical Plan

1.4.1 SampleSize 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.

1.4.2 StatisticalMethods
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.

Version Date

Page 4 of 6

4.2 Records Retention

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.

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 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.

Version Date

Page 5 of 6

7 Publication Plan
Describe 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. 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).

Version Date

Page 6 of 6