Appendix 2- Questions Frequently Asked During FDA Inspections

Overview of the study

  1. Provide an overview of the study including background, objectives, study design, duration of the study, subject population, and number of subjects enrolled.
  2. What responsibilities are delegated to other members of study team?
  3. How are potential subjects identified?
  4. Who screens and recruits subjects?
  5. Were all methods and materials used for recruitment IRB approved?
  6. Who verifies inclusion and exclusion criteria?
  7. Who obtains consent/assent?
  8. Was written documentation of consent required?
  9. Is the informed consent process documented in the medical record?
  10. Was assent required? (Include age of assent)
  11. Were there any research participants who were wards of the state?
  12. How are screening/enrollment logs used and maintained during the conduct of the study?
  13. Where were study procedures conducted? (e.g., inpatient or outpatient)
  14. What are the study start and/or completion dates?
  15. How do you communicate protocol or study design changes to study staff, pharmacy, and/or ancillary department staff?
  16. How do you obtain, record, secure, and retain data?
  17. What do you use as source documentation (study specific source documents, separate research chart, shadow chart, CRFs, lab data, imaging or diagnostic data)?
  18. Do you use electronic records?
    1. How are records validated?
    2. Do you use electronic signatures?
    3. What are the data security/controls?
    4. Is there an inspection trail?
  19. Was data transferred or transmitted outside the institution?
  20. What is your record retention policy?
  21. Were there any protocol deviations or exemptions?
  22. Who is responsible for receipt, distribution, administration and accountability of test articles?
  23. Who are the investigational pharmacists?
  24. How is the test article stored?
  25. Describe procedures for destruction and/or return of the test article.
  26. Where and how are specimens stored?
  27. Describe your procedure for maintaining and documenting storage of specimens.
  28. Describe maintenance of temperature logs and how you deal with temperature excursions, including:
    1. Frequency of temperature monitoring (manual check or electronic monitoring)
    2. Frequency of quality control checks
  29. Was the study routinely monitored?
    1. Documentation of monitoring communications and evaluations
    2. Frequency of monitoring
    3. Was the study team satisfied with overall monitoring of the study?
  30. Did study team receive study-specific training?
    1. Documentation of training
    2. Study team training, pharmacy
  31. Did any unanticipated problems occur (AEs, SAEs or deaths)?
    1. Were events reported to the IRB, Sponsor, IRB, regulatory agency in a timely manner?
    2. Were the event related to the test article?
    3. Did the subject require any intervention/treatment as the result of the event?
    4. What was the intervention/treatment?
  32. Are there any study specific standard operating procedures (SOPs) for this study?
  33. Is the study registered with or equivalent registry?