Who conducts external regulatory inspections of clinical trials?

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External regulatory inspections are conducted by regulatory authorities—the official agencies empowered to oversee clinical trials and enforce relevant laws and guidelines. Their role is to verify that trials are run in accordance with Good Clinical Practice, regulatory submissions, informed consent, safety reporting, and accurate data records. These inspections can target trial sites, sponsor offices, or contract research organizations and involve reviewing documents, interviewing staff, and observing procedures. Because the inspecting body has formal authority and comes from outside the sponsor or site, the process is considered external regulatory oversight. Internal audits by sponsors or QA teams occur, but they are internal checks, not external regulatory inspections, and participants do not have the authority to perform official inspections.