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What are some common deficiencies that have been observed by FDA investigators during a clinical investigator inspection?

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Some common deficiencies observed by FDA investigators include:

  • Failure to follow the investigational plan and signed investigator statement/agreement (e.g., failure to conduct or supervise the study in accordance with the relevant, current protocol(s)). See 21 CFR 312.60 and 812.110(b).
  • Protocol deviations (e.g., failure to appropriately document and report any medically necessary protocol deviations). See 21 CFR 312.66 and 812.150(a)(4).
  • Inadequate record keeping. See 21 CFR 312.62 and 812.140(a).
  • Inadequate accountability for the investigational product. See 21 CFR 312.62(a) and 812.140(a)(2).
  • Inadequate subject protection, including informed consent issues. See 21 CFR part 50, 312.60, and 812.100.

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