Tools and Checklists
Quality and Compliance Documentation:
- Quality Management Plans (HUB)
- Delegation of Authority Documentation Log
- Drug or Biologic Dispensing / Accountability Log
- Screening / Enrollment / Withdrawal Log
- UCSF Corrective and Preventative Action (CAPA) Training Log
- Device Dispensing / Accountability Log
- Example: Study Events Tracking Form
- Example: Tracking System for Deadlines and Reporting
- On-site assessment assessment and training for researchers: Routine Site Audit Request
- FDA and OHRP Inspections: Please notify UCSF upon receiving the call or letter to schedule the inspection. See the OEC's Inspection website for more information about whom to contact and how to prepare for the inspection.
FDA and OHRP Inspections
- FDA and OHRP Inspections: Please notify UCSF upon receiving the call or letter to schedule the inspection. See the OEC's Inspection website for more information about whom to contact and how to prepare for the inspection.