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Frequently Asked Questions

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What types of specific documents should the investigator retain at the completion of a clinical study with an IND (Investigational New Drug) Application?

All study documents should be retained by the Investigator, including, but not limited to:

  • all Case Report Forms (CRFs/eCRFs), data Clarification forms collected
  • complete subject identification list
  • audit certificate (if required)
  • Final trial close out monitoring report
  • Randomization/Treatment allocation and decoding document
  • IRB communications and Final report to IRB/IEC
  • Clinical study report
  • Records of disposition of drug, including dates, quantity, and use by subjects
  • Clinical case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation.
  • Any clinical records used to support billing submitted and payments received for protocol services


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