Research Tools and Checklists

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Tools and Checklists

FDA and OHRP Inspections

 

Tools and Checklists

Below is a collection of tools to assist in the conduct and management of clinical research:

UCSF Routine On-Site Review Form

Quality Management Plans

Regulatory Binder Requirements

​​Standard Operating Procedures

Delegation of Authority Documentation Log

Drug or Biologic Dispensing / Accountability Log

Screening / Enrollment / Withdrawal Log

Device Dispensing / Accountability Log

FDA and OHRP Inspections

Please notify UCSF upon receiving the call or letter to schedule the inspection. See the UCSF Clinical Research HUB for more information about whom to contact and how to prepare for the inspection.