Resource Library

The Office of Human Research Affairs aims to provide the research community with up to date guidance and tools to assist with the development and execution of all research projects. The Resources Library is updated on an ongoing basis based on recognized needs. All the templates and guidance posted here are available for public download.

The forms and documents below are available for download.

Clinical Trials.gov

U.S. Department of Health and Human Services (DHHS) Regulations

U.S. Food and Drug Administration

FDA Device Advice

FDA Regulatory Guidance

Office for Human Research Protections (OHRP)