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Sunday, November 7, 2010



Upon arrival at the clinical investigator study site, the US FDA investigator displays his/her FDA credentials and issue a completed Form FDA 482 (Notice of Inspection) to the clinical investigator or appropriate study staff. FDA is authorized at reasonable times to access, inspect, and copy any required records related to the clinical investigation. See section 704 of the Federal Food, Drug, and Cosmetic Act (21 USC 374), 21 CFR 312.68, and 21 CFR 812.145.
During an inspection at the site of a clinical investigator, the FDA investigator typically verifies compliance with the regulations governing the use of investigational products and human subject protections at 21 CFR parts 50, 56, 312, and/or 812, by inspecting records and talking to individuals involved in the conduct of the study to ascertain:
• who performed various aspects of the protocol for the study (e.g., who verified inclusion and exclusion criteria, who obtained informed consent, who collected adverse event data);
whether the IRB approved the protocol, informed consent form, and any amendments to the protocol prior to implementation;
whether the clinical investigator and study staff adhered to the sponsor’s protocol and investigational plan and whether protocol deviations were documented and reported appropriately;
whether informed consent documents were signed by the subject or the subjects’ legally-authorized representative prior to entry in the study (i.e., performance of any study-related procedures);

• whether authority to conduct aspects of the study was delegated, and if so, how the conduct of the study was supervised by the clinical investigator;
• where specific aspects of the investigation were performed;
• how the study data were obtained and where the study data were recorded;
• accountability for the investigational product, including shipping records and disposition of unused investigational product;
whether the clinical investigator disclosed information regarding his financial interests to the sponsor and/or interests of any subinvestigator(s), spouse(s) and dependent children;

• the monitor’s communications with the clinical investigator;
• the monitor’s evaluations of the progress of the investigation; and
corrective actions in response to previous FDA inspections, if any, and regulatory correspondence or sponsor and/or monitor correspondence.

The FDA investigator also may audit the study data by comparing the data filed with the agency or the sponsor, if available, with records related to the clinical investigation. Such records may include the case report forms and supporting source documentation including signed and dated consent forms and medical records including, for example, progress notes of the physician, the subject’s hospital chart(s), and the nurses’ notes. These records may be in hard copy and/or an electronic format. For electronic records and/or electronic signatures, the FDA investigator may gather information to determine whether 21 CFR part 11 requirements have been met FDA may also examine subjects’ medical records that are part of the clinical investigation and predate the study to verify whether the condition under study was in fact diagnosed, the study eligibility criteria were met, and whether the subject received any potentially interfering medication prohibited by the protocol. The FDA investigator may also review subjects’ records covering a period after completion of study-related activities to determine if there was proper follow-up as outlined in the protocol, and if the clinical investigator submitted all reportable adverse events (including all clinical signs and symptoms). See 21 CFR 312.64(b) and 812.150(a).

Requiremets US FDA Inspections of Clinical Investigators of Clinical Trials



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