Study Management Templates and Guidance

Overview

The study management templates are adaptable and downloadable templates that can be used to organize and maintain research study documentation as you would include in a regulatory binder. 

The templates can also help you adhere to high standards of practice in the conduct of studies involving human participants. The study management templates are a University of Michigan resource available to all study team members.

These templates are designed to help meet requirements for FDA-regulated clinical trials. They may be useful, but not required, to organize study documentation for other studies as well.

Please customize the templates to match your study-specific requirements.

Guidance documents are also provided to assist you with study management.


Downloads

Templates:

Note-to-File.doc To document the reason for missing, delayed or erroneous documents, procedures, etc., in the site master file or in participant data. This template will assist in explaining protocol deviations or investigator site practices that differ from the norm or from what is prescribed in the protocol.

Protocol Deviation Tracking Log.doc This template lists all of the protocol deviations from a particular study. The template may also be used to submit accumulated deviations to the IRB at the time of a continuing review for a study.

Protocol Training Log.doc When conducting a clinical trial, it is the investigator’s responsibility to ensure each member of the study team is trained on the protocol as it applies to their job function. This template can be used to keep track of protocol training.

Screening and Enrollment Log.docx This log documents and tracks the status of each potential or enrolled participant in a study.

Document Tracking Log.docx This template tracks versions, approval dates, and the location of important documents during initiation through close-out of a research study.

eResearch Submissions Log.xlsx Use this log to document IRB submissions, descriptions of submissions, and dates of submissions and approvals.

Study Member Tracking Log.xlsx Track study team members’ study requirements such as updated CVs, signed Delegation of Authority Log, human participant training, financial disclosure, and other requirements per protocol.

Delegation of Authority Log.doc This template records all assigned study-related responsibilities.

Study Participant Withdrawal and Termination Log.docx This log may be used to document the number of participant withdrawals and terminations, as well as the reasons for withdrawal or termination. A participant may withdraw their consent to participate in the study, or the principal investigator may terminate a participant based on safety issues or other factors.

Monitor Visitor Log.docx This log should provide a comprehensive list of all monitoring visits. This template records all monitoring visits beginning with set-up.

Site Initiation Visit Agenda.doc This template serves to organize a Site Initiation Meeting to guide the content of the meeting in order to ensure the site is prepared for the proper conduct of the study.

Contacts Reference List.docThis template ensures that necessary staff and others can be contacted when needed. Use it to create a record of contact information for research team members and other parties that are involved in the study.

Study Participant Visit Checklist.doc This template helps track a research participant’s study visit to ensure that protocol-designated procedures for each visit are completed.

Eligibility Checklist.docx This checklist documents and tracks a participant’s eligibility to take part in a study according to the criteria specified in the IRB approved protocol or research plan.

Participant Identification Code Key.docx This template will link the assigned study identification number to the actual patient identity. It can be used to link enrolled participant identity or protected health information to their research data.

Participant Contact Information Form.doc This template assists the study team in contacting study participants.

Chain__Cust__FINAL_02Jun2017 v 2_1.doc This template is intended for use in tracking the dispensing to and return of study drug from research participants, after they have been given by the Research Pharmacy to the research team.

Device Accountability Log.doc This template allows the principal investigator and study team to fulfill their responsibilities regarding device accountability record maintenance for significant risk devices.

Documentation of the Informed Consent Process for Research Participation.docx This template is one way to document the initial consenting process, along with the informed consent document.

Study Participant Telephone Call Log.docx This template can be used to document study-specific conversations with or about a study participant.

Unblinding Study Article Form.doc This form, used in those studies where the study article is blinded, tracks when a participant’s study article is unblinded.

Document Inventory at Study Termination.docx This template assists the principal investigator and study team in fulfilling their responsibilities regarding study close-out when all study activities are terminated.

Guidance Documents:

Sponsor Communication.docx This document provides guidance on communication with your sponsor.

Drug Accountability.docx This document provides guidance on study drug accountability.

Questions and Disclaimer

For questions about regulatory requirements, please contact the Office of Regulatory Affairs UMMS-RegAffairs@med.umich.edu.

Resources on this page may not be an exhaustive list. If you know of other resources in this category, please let us know using the "Suggest a Resource" link at the bottom of the page.

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