Good Clinical Practice (GCP) Toolbox

The following are some recommended documentation tools and general guidance.  Each study is unique and many of the tools provided below may require modification to capture protocol specific documentation. 

GCP Guidelines: Study Documentation 

Human Research Study Start-Up

Subject File Documentation Templates

Regulatory File Documentation Templates

National Institutes of Health (NIH) GCP Toolboxes

FDA Inspection Tools

For guidance on audits or inspections being conducted by federal regulatory agencies (e.g., FDA, NIH, DOD) visit the Human Research Protection Office (HRPO) website's Audit by Federal Agency page.