Regulatory Science Symposium: Monitoring and Auditing 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


Accompanying text created by Amelia Spinrad | Regulatory Knowledge Support Specialist |

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