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
• Source Data Identification Form (New!)

Templates

• Adverse Event Log
• Concomitant Medication Log
• Site eISF template from MAGI
• Joint GU/MHRI Clinical Research Policies and SOPs Training Log
• Clinical Research Staff Training Log (New!)
• Drug Dispensation and Accountability Log (Subject-Specific) (New!)
• Protocol Portfolio Tracker (New!)