Regulatory Science Symposium: Monitoring and Auditing Session 2: FDA Inspections - Getting Ready (2016)

1. Background and the regulations
   • Bioresearch Monitoring Inspections (BIMO) objectives are (1) to protect the rights, safety and welfare of human research subjects and (2) to assure the quality, reliability, and integrity of data collected
   • FDA inspections are data driven while EMA inspections are process driven 
   • FDA inspections are sponsored by triggers
     • NDA/BLA submission
     • Sites high enrolling
     • Conducting trials in multiple therapeutic areas
     • Outliers
     • Study closure due to noncompliance
     • Unusual data
     • Subject complaints
     • Whistleblowers
2. Preparation of a clinical site
   • Logistics
     • Process handling document requests
     • Tour
     • Sponsor assistance
   • Document Retrieval
     • Study Files, records and patient charts.
     • Being proactive in retrieval of records
   • Document Review
     • Documentation should be in order and up to date
     • Any changes in protocol should be incorporated
   • Staff Preparation
     • BIMO compliance manual
     • inspection etiquette
     • handling request for documents
   • External Assistance
     • Listen carefully
     • Answer honestly
3. Preparation of a sponsor
   • Logistics
     • Inspection room, QA representative, Scribes, Subject matter experts
     • Prep Room, QC Personnel, Document Management
     • Quiet Room, Briefing subject matter experts
     • Tools like storyboards, BIMO Checklist, Distribution Lists, Contact Lists, templates, databases, readiness guide to be prepared
     • Supplies preparation
     • Interview Practice Sessions, Management, Monitoring and Quality Assurance
4. General information
   • Interview Advice
   • Mock Inspection: Executed using inspection room
   • BIMO inspections are pre-announced- Investigators provide IRB# and FDA Form 482.
   • Delays in scheduling or refusal can result in product to be deemed adulterated

• Division of Bioresearch Monitoring
• Device advice
• FDA GCP programs
• Application Integrity Policy list
• Disqualification List

Accompanying text created by Amelia Spinrad | Regulatory Knowledge Support Specialist | spinrad@usc.edu