Quality Management Services

Study Tools

• ALCOA-C Checklist
• Consideration for Re-consenting
• CRC Hand-Off Checklist for CRC Handing-Off Studies
• CRC Hand-off Checklist for CRC Receiving Studies
• Weekly Team Meeting Checklist
• Internal QA Review
  • Regulatory Documents Review
  • Subject Chart Review
• Source Data Identification Form 

Study Templates

• Adverse Event Log
• Concomitant Medication Log
• Site eISF template from MAGI
• Clinical Research Staff Training Log 
• Drug Dispensation and Accountability Log (Subject-Specific) 
• Protocol Portfolio Tracker 
• Deviation Tracker 
• Joint GU/MHRI SOP Training Log 
• Delegation of Authority Log
• Guidance for using eISF BOX template (New!)
• Eligibility Checklist Template (New!)

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