SOCRA CCRP Practice Exam

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What is the role of a sponsor in clinical trials per 21 CFR 312.3?

The regulatory authority approving the drug
The individual who reviews trial outcomes
The person responsible for initiating the clinical investigation
The participant volunteering for trials

The correct answer is: The person responsible for initiating the clinical investigation

The sponsor is responsible for initiating the clinical investigation, meaning they provide the financial and operational support for the trial. This includes selecting the study site, overseeing the conduct of the trial, and reporting its results to the regulatory authority (A) for approval (not necessarily approving the drug themselves). The individual responsible for reviewing trial outcomes (B) is typically the principal investigator. The participant (D) is not the sponsor, but rather the subject of the trial.