Monitoring and Auditing Bootcamp Session 2: FDA Inspections - Getting Ready (2016)

In this series, we will discuss regulatory complexities regarding clinical trials.


Course Syllabus/Topics

  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

Recommended Reading and Resources


Acknowledgement

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


NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.