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Regulatory Document Management

Study Administrative Files

Federal regulations require the existence and maintenance of documents relating to a study. These documents, when properly maintained, provide clear evidence that the study has been conducted according to federal regulations and GCP guidelines. The Study Administrative File is the central file for all of these critical regulatory documents. Guidance on the Study Administrative File and study document management is provided in the Study Documentation Management section of the Penn Manual for Clinical Research
The Study Administrative File template provides a framework for what regulatory documents should be filed in each section. Click on a type of human research below for information on applicable documents, and for instructions on downloading the template.