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During a multi-site clinical study, who is responsible for reporting the subject recruitment rate?

The site investigator

The Clinical Research Associate (CRA)

In a multi-site study, recruitment metrics are monitored and reported by the Clinical Research Associate. The CRA conducts site monitoring visits, verifies that enrollment numbers in source documents match the electronic case report forms, and compiles recruitment data into reports for the sponsor or CRO. This role serves as the day-to-day link between individual sites and the sponsor, ensuring timely, accurate reporting of how many subjects have been screened and enrolled. The site investigator is responsible for conducting the trial at their site and enrolling subjects according to the protocol, but the formal reporting of recruitment rates to the sponsor comes from the CRA. The sponsor oversees the study overall and may request reports, but routine recruitment reporting is not their sole, day-to-day duty, and regulatory agencies do not handle ongoing site-by-site recruitment reporting.

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The study sponsor

The regulatory agency

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