FDA INSPECTION INTELLIGENCE · BIORESEARCH MONITORING

Most common FDA 483 observations in Bioresearch Monitoring

The observation types FDA cites most often on Form 483 in Bioresearch Monitoring inspections, ranked by how many times each has been written up. Every line is FDA's own citation text — select one to see what it means, why FDA cites it, and how to comply.

Top 50 observation types

  1. #1FD-1572, protocol compliance1,022 · 976 firms
  2. #2Case history records- inadequate or inadequate563 · 547 firms
  3. #3Accountability records134 · 132 firms
  4. #4Minutes of IRB meetings92 · 85 firms
  5. #5General responsibilities of sponsors88 · 81 firms
  6. #6Informed consent68 · 68 firms
  7. #7Consent form not approved/signed/dated66 · 66 firms
  8. #8Initial and continuing reviews53 · 48 firms
  9. #9List of members49 · 48 firms
  10. #10Safety reports47 · 47 firms
  11. #11Unanticipated problems44 · 44 firms
  12. #12Initial and continuing review43 · 42 firms
  13. #13Changes in research40 · 40 firms
  14. #14Members present for review36 · 34 firms
  15. #15Safety Reports - Serious Events35 · 35 firms
  16. #16Consent not obtained, exceptions do not apply29 · 29 firms
  17. #17Record retention28 · 28 firms
  18. #18Safety Reports - Non-Serious Events25 · 25 firms
  19. #19Ensuring compliance with plan and protocol24 · 23 firms
  20. #20Reasonably foreseeable risks or discomforts23 · 23 firms
  21. #21Prompt reporting of noncompliance19 · 19 firms
  22. #22Circumstances of obtaining consent18 · 17 firms
  23. #23Confidentiality, FDA inspection of records18 · 18 firms
  24. #24Failure to submit an IND17 · 17 firms
  25. #25ClincialTrials.gov statement15 · 15 firms
  26. #26Conflict of interest15 · 15 firms
  27. #27Method to keep members advised15 · 15 firms
  28. #28Investigator non-compliance14 · 13 firms
  29. #29Continuing review13 · 13 firms
  30. #30Monitoring investigations13 · 13 firms
  31. #31Procedures, identification of those which were experimental13 · 13 firms
  32. #32Written procedures per 56.108(a) and (b)13 · 12 firms
  33. #33Retention of records12 · 12 firms
  34. #34Copy of consent form not provided11 · 11 firms
  35. #35Investigator statement (FDA 1572)11 · 11 firms
  36. #36Records of continuing review11 · 11 firms
  37. #37Annual report10 · 10 firms
  38. #38Records of receipt, shipment, disposition10 · 10 firms
  39. #39Alternate procedures, courses of treatment9 · 9 firms
  40. #40Notification of FDA of termination of investigator9 · 8 firms
  41. #41Reporting9 · 9 firms
  42. #42Research not eligible for expedited review9 · 9 firms
  43. #43Understandable language9 · 9 firms
  44. #44One scientific and one non-scientific member8 · 8 firms
  45. #45Prompt reporting of unanticipated problems8 · 8 firms
  46. #46Reporting of suspension/termination8 · 8 firms
  47. #47Unused drug disposition (investigator)8 · 8 firms
  48. #48Changes in contact or chairperson information7 · 7 firms
  49. #49Copies of IRB/CI correspondence7 · 7 firms
  50. #50IRB approvals/disapprovals - general7 · 7 firms