Study Management Templates and Guidance

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

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This resource may be used by anyone at U-M.


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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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