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When will waivers be needed for 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
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

FDA believes that many sponsors and applicants will be able to comply with 21 CFR 312.120, and therefore will not request waivers, because many foreign clinical investigations are conducted in accordance with GCP principles. For this reason, when publishing the rule, FDA anticipated relatively few waiver requests. Experience to date has confirmed that waiver requests are rare. Sponsors or applicants may nonetheless ask FDA to waive any applicable requirements under 21 CFR 312.120(a)(1) and (b) by submitting a waiver request under 21 CFR 312.120(c). FDA will decide whether to grant or deny waivers on a case-by-case basis, taking into account all appropriate circumstances.

FDA anticipates that waivers may be sought, for example, in the following circumstances:

  • To allow for acceptance of a non-IND foreign clinical study conducted before the effective date of the revised 21 CFR 312.120 (April 28, 2008). The sponsor or applicant may submit a request for waiver if the study was in compliance with the provisions of 21 CFR 312.120 at the time it was conducted but was out of technical compliance with the terms of the revised 21 CFR 312.120.
  • If FDA requests case records maintained by the investigator or additional background data, such as hospital or other institutional records, but these documents cannot be provided as required by 21 CFR 312.120(b)(3) because disclosure is prohibited by governing law. In this case, the sponsor or applicant should document this disclosure prohibition by the foreign entity (e.g., the countries that prohibit such disclosure, the nature of the prohibitions, and the extent to which these prohibitions may impede sponsors in carrying out other obligations requiring record access). The sponsor or applicant can then submit such information in a waiver request to FDA. For FDA to rely on the affected data, the sponsor and FDA would need to agree on an alternative validation procedure.
  • If the sponsor or applicant cannot obtain IEC member names as required by 21 CFR 312.120(b)(6), because of governing law relating to privacy concerns. In this instance, FDA recommends that the sponsor or applicant clearly document attempts made to obtain the names along with an explanation as to why the names cannot be obtained. Such information can be submitted to FDA in a waiver request.

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