US FDA Inspections of Clinical Investigators of a Clinical Trial
US FDA has a program to help ensure the protection of the rights, safety, and welfare of human research subjects involved in FDA-regulated clinical trials, to verify the accuracy and reliability of clinical trial data submitted to FDA in support of research or marketing applications, and to assess compliance with statutory requirements and FDA’s regulations governing the conduct of clinical trials. Among other activities, it involves site visits to clinical investigators, sponsors, monitors, contract research organizations, Institutional Review Boards (IRBs), nonclinical (animal) laboratories, and bioequivalence analytical laboratories. This document addresses site visits to clinical investigators who conduct clinical investigations that are regulated by FDA under 21 USC 355(i) or 21 USC 360j(g).
Clinical investigators either conduct a clinical trial or are the responsible party of a team of investigators. See 21 CFR 312.3 and 812.3(i). The clinical investigator is responsible for protecting the rights, safety, and welfare of subjects under the investigator’s care. See 21 CFR 312.60 and 812.100.
This series of articles is intended to provide information about US FDA inspections of clinical investigators conducted under US FDA’s Bioresearch Monitoring (BIMO) Program, in accordance with the US FDA’S regulations and Good Guidance Practices (21 CFR 10.115).
WHEN ARE CLINICAL INVESTIGATOR INSPECTIONS CONDUCTED?
US FDA conducts clinical investigator inspections to determine if the clinical investigators are conducting clinical studies in compliance with applicable statutory and regulatory requirements. Clinical investigators who conduct US FDA-regulated clinical investigations are required to permit FDA investigators to access, copy, and verify any records or reports made by the clinical investigator with regard to, among other records, the disposition of the investigational product and subjects’ case histories. See 21 CFR 312.68 and 812.145. The FDA investigator typically performs this oversight function through on-site inspections designed to document how the study was actually conducted at the clinical investigator’s site. For investigational drug studies, clinical investigators must retain study records for a period of two years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until two years after the investigation is discontinued and FDA is notified. See 21 CFR 312.62(c). For investigational device studies, clinical investigators must retain study records for a period of two years after the latter of the following two dates: The date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol. See 21 CFR 812.140(d).
FDA conducts both announced and unannounced inspections of clinical investigator sites, typically under the following circumstances:
• to verify the accuracy and reliability of data that has been submitted to the agency;
• as a result of a complaint to the agency about the conduct of the study at a particular investigational site;
• in response to sponsor concerns;
upon termination of the clinical site;
during ongoing clinical trials to provide real-time assessment of the investigator’s conduct of the clinical trial and protection of human subjects;
Also see US FDA requirements of reporting of adverse events in a clinical trial US FDA has recently updated its requirement.
• at the request of an FDA review division; and
• related to certain classes of investigational products that FDA has identified as products of special interest in its current work plan (i.e., targeted inspections based on current public health concerns).
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