Regulatory Science Symposium: Clinical Trials Hurdles Session 3 - FDA GCP Inspections (2015)

• FDA Administration

  
  

  • FDA’s mission is to be responsible for protecting public health
  • Interstate jurisdiction
  • Compliance secured through programs like BIMO
• Bioresearch monitoring programs (BIMO)
  • Clinical investigators (CIs)
  • Institutional review boards (IRBs)
  • Sponsors/Monitors/CROs
  • Radioactive drug research committee
  • In-vivo bioequivalence
  • Good laboratory practices (GLP)
• Clinical investigator commitments on drugs & devices
• The consent process
  • Informed consent
  • Basic elements of the consent process
  • Non-English speaking process
• Clinical investigator and their responsibilities
  • All changes
  • All unanticipated problems
  • Safety reports
  • Report days
• Inspection assignments
  • Issued by FDA centers to field
  • Duration: 7 days or longer
• Inspection assignment: site selection
  • More inspections while trials are on-going
  • “Risk-based” site selection
• FDA investigator’s background
  • Field investigators – minimum 4 years college degree
  • FDA trained to conduct inspections of clinical investigations
  • Experience in conducting inspections of clinical investigators
• Inspection activates
  • Announce inspection
  • Opening interview
  • Interviewing staffs
  • Reviewing study documents – informed consents, administrative records, etc.
  • Critical issues
  • Study supervision
  • Exit interview – may issue an FDA-483
• Post Inspection
  • Establishment inspection report (EIR)
  • EIR reviewed by FDA HQ staff
  • Final classification sent to field office
  • Reviewing FDA center sends letter to clinical investigator after review
  • Field sends FMD-145 letter with copy of report to clinical investigator
  • Also available to anyone through FOIA
• Possible outcomes of FDA clinical investigator inspections
  • Administrative actions:
    • Warning letters
    • Clinical holds
    • Rejection of data
    • Etc.
• Common deficiencies at clinical sites
  • Failure to follow the protocol and/or regulations
  • Protocol deviations
  • Inadequate and inaccurate records
  • Inadequate accountability
  • Inadequate communication with the IRB
  • Inadequate subject protection
• Tips for a successful study
  • Enhance study adherence
  • Simple protocol design
  • Essential data points
  • Avoid ambiguity and vagueness
  • Fully understand protocol limits
  • All records should meet the ALCOA test
  • Enhancing record quality
  • Understand regulatory responsibility
  • Communication is important 

Accompanying text created by Annie Ly | Undergraduate Research Associate and Provost's First Generation Research Fellow | lyannie@usc.edu