FREQUENTLY Asked Questions
If a sponsor chooses to conduct a foreign clinical study under an IND and the investigators comply with ICH E6 GCP Consolidated Guidance, would non-US investigators also be in compliance with FDA’s IND requirements?
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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.

Yes, but with two exceptions:

  • The FDA requirements involving Investigational Review Boards (IRBs) is rather different with respect to membership and function under 21 CFR 56. To address these differences, the FDA provides a waiver from IRB requirements of part 56 and allows for Independent Ethics Committee (IEC) that complies with good clinical practices (GCPs) to replace IRB.
  • The informed consent requirements for special clinical trials (such as emergency research under 21 CFR 50.23, clinical investigations involving pediatric subjects under Subpart D) are more extensive in regards to IRB responsibilities. Since such trials are very uncommon and has not caused conflicts in the past, the FDA will discuss resolutions with the respected sponsors on case-by-case basis. If the investigator or sponsor sense conflicting requirements, the sponsor can request a waiver from the FDA from specific requirements under 21 CFR 312.10.

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