Study Management Templates and Guidance
A guide to regulatory documentation and maintaining high standards in human participant research
Who?
When?
How much?
Free
Questions
Contact us at [email protected]
Downloads
- Delegation of Authority Log
- Contacts Reference List
- Investigator Chain of Custody Log for Study Drug
- Electronic Regulatory Binder Example for Single Site Studies
- Electronic Regulatory Binder Example for Multi-Site Studies
- Documentation of the Informed Consent Process for Research Participation
- Document Inventory at Study Termination
- Eligibility Checklist
- eResearch Submission Tracking Log
- Monitor Visit Log
- Note-to-File
- Study Participant Withdrawal and Termination Log
- Participant Contact Information Form
- Participant Identification Code Key
- Protocol Deviation Tracking Log
- Protocol Training Log
- Screening and Enrollment Log
- Site Initiation Visit Agenda
- Sponsor Communications
- Study Participant Telephone Call Log
- Study Participant Visit Checklist
- Table of Contents for Electronic Regulatory Binder Example for Single Site Studies
- Table of Contents for Electronic Regulatory Binder Example for Multi-Site Studies
- Unblinding* Study Article Form
- Device Accountability Log
- Study Team Member Tracking Log
- Drug accountability Language
What is this resource?
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.
How this advances translational science
Implementing operations that facilitate and support the quality and impact of research.
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