US FDA INSPECTION OF CLINICAL INVESTIGATORS OUT OF UNITED STATES OF AMERICA (INTERNATIONAL INSPECTIONS OF CLINICAL INVESTIGATORS)
FDA’s inspection of clinical investigators is not limited to the United States (U.S.). International inspections are generally conducted when the studies are part of a marketing application submitted to FDA and provide data critical to decision-making on product approval. “Clinical Investigators and Sponsor-Investigators.” Such assignments include studies that are conducted under an FDA investigational new drug application (IND), as well as studies at non-U.S. sites that are not conducted under an IND or under an investigational device exemption (IDE).
Studies Involving Investigational Drugs and Biologics
FDA inspects clinical investigators conducting foreign trials, either under an IND or in support of an IND, a new drug application (NDA) or a biologics license application (BLA). Although sponsors of clinical trials conducted outside the U.S. are not required to file an IND, sponsors submitting foreign clinical studies not conducted under an IND to FDA must comply with requirements in 21 CFR 312.120. If a clinical investigator conducts a study under an IND outside of the U.S., the clinical investigator is subject to FDA regulations, including applicable provisions in 21 CFR parts 50, 56, and 312. FDA validates the authenticity and accuracy of data and confirms compliance during an inspection, which is performed under the circumstances listed above in section III.
When FDA considers whether to accept non-U.S., non-IND clinical studies in support of an IND, NDA, or BLA, an FDA inspection may help in determining whether the study was conducted in accordance with 21 CFR 312.120. Specifically, the inspection will evaluate whether the following criteria are met:
*The study is well-designed and well-conducted.
*The study is conducted in accordance with Good Clinical Practice (GCP), which is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that provides assurance that the data and reported results are credible and accurate and that the rights, safety, and well-being of trial subjects are protected.
*The study has been reviewed and approved (or provision of a favorable opinion) by an independent ethics committee (IEC) prior to study initiation, continuing review of an ongoing study by an IEC, and the freely given and documented informed consent of the subject (or the subject’s legally authorized representative if the subject is unable to provide consent) prior to any study-specific procedures.
Studies Involving Investigational Devices
FDA’s inspection of clinical investigators conducting foreign trials includes device trials in support of a premarket approval application (PMA) or a premarket notification (510(k)) submission.
For device studies conducted outside the U.S., FDA will accept research in support of a PMA, but which has not been conducted under an IDE, if certain conditions are met. An FDA inspection may help in determining whether the study was conducted in accordance with 21 CFR 814.15. Specifically, the inspection will evaluate whether the following criteria are met: the data are valid; and the studies are conducted in conformance with the laws and regulations of the country in which the research is conducted, whichever affords greater protection to the human subjects.
US FDA validates the authenticity and accuracy of data and confirms compliance during an inspection, which is performed under the circumstances listed above in section III. The FDA investigator may request documentation as to whether the study was conducted under the laws and regulations of the non-U.S. country and/or the Declaration of Helsinki, whichever accords greater protection to human subjects.
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