ORQA Study Tools & Templates

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
• FDA Inspection Preparation Guide and Resources

Templates

• Adverse Event Log
• Concomitant Medication Log
• Site eISF template from MAGI
• Joint GU/MHRI Clinical Research Policies and SOPs Training Log