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
- Guidelines: Study Documentation for FDA Regulated Research and Clinical Trials
- ALCOA-C Printable Quick Reference
Human Research Study Start-Up
Subject File Documentation Templates
- Adverse Events Log
- Adverse Events (Serious Adverse Event) Report
- Concomitant Medications Log
- Eligibility Checklist
- Informed Consent Process Documentation
- Child Informed Consent Process Documentation
- Phone Screening Log
- Progress Note
- Study Disposition Form
- Study Communication Log
- Visit Checklist
Regulatory File Documentation Templates
- Data Safety and Monitoring Minutes Form
- Investigational Drug Accountability Record
- Investigational Device Accountability Log
- Delegation of Authority Log
- Training Log
- Wet-Ink Signature Log
- Pre-Screening Log
- Enrollment Log
- Noncompliance / Deviations Log
- Monitoring Visit Log
- Source Data Identification Log
- Electronic Regulatory File Organization
- Study Close Out Checklist
National Institutes of Health (NIH) GCP Toolboxes
- National Institute of Aging
- National Institute of Mental Health
- National Center for Advancing Translational Sciences
- National Institute of Neurological Disorders and Stroke
- National Center for Complementary and Integrative Health Research Toolbox
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.