ORQA Auditing

Auditing is a systematic, independent examination conducted to ensure compliance with regulations and standards at a given moment in the clinical trial. The focus of the audit is process based and involves corrective and preventative actions to ensure ongoing compliance.  

Monitoring, on the other hand, involves ongoing continuous oversight of study activities and data to ensure adherence to the protocol and identify issues in real-time.

Request an Audit

Please complete the ORQA Audit Request Form. An ORQA member will contact you shortly.

FDA Inspection Resources

• ORQA FDA Inspection Preparation Guide
  • APPENDIX A: FDA Inspection Initial Contact Form
  • APPENDIX B: Administrative Checklist
  • APPENDIX C: Regulatory Documents Review Tool
  • APPENDIX D: Subject Chart Review Tool
  • APPENDIX E: Daily Report Form
  • FDA Inspection Request Tracker
  • FDA Inspector PI Questions

External Audit Resources

• External Audit Request Tracker
• More resources coming soon!

Corrective Action/Preventive Action (CAPA) Resources

• 5 Whys Worksheet
• CAPA Explained
• Georgetown CAPA Template
  • if you need assistance in developing a CAPA plan, email ORQA at ORQA@georgetown.edu
• Georgetown CAP Template