FREQUENTLY Asked Questions
What supporting information is necessary for FDA acceptance of a foreign clinical studies not conducted under an IND?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

Sections include:

  • Investigator qualifications
  • Description of the research facilities
  • Detailed summary of the protocol and study results and, if requested, case records or additional background data
  • Description of the drug substance and drug product, including the components, formulation, specifications, and, if available, the bioavailability of the drug product
  • Information showing that the effectiveness study is adequate and well controlled under 21 CFR 314.126
  • The name and address of the IEC that reviewed the study and a statement that the IEC meets the definition in 21 CFR 312.3(b)
  • Summary of the IEC’s decision to approve or modify and approve the study, or to provide a favorable opinion
  • Description of how informed consent was obtained
  • Description of what incentives, if any, were provided to subjects to participate
  • Description of how the sponsor monitored the study and ensured that the study was carried out consistently with the study protocol
  • Description of how investigators were trained to comply with GCP and to conduct the study in accordance with the study protocol, and written commitments by investigators to comply with GCP and the protocol

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