Study Management Templates and Guidance

A guide to regulatory documentation and maintaining high standards in human participant research

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.