Regulatory Affairs Certification (RAC) 2025 – 400 Free Practice Questions to Pass the Exam

The minimum time allowed to submit a request for a Special Protocol Assessment (SPA) for a clinical trial is 90 days. This requirement is established by regulatory guidelines, designed to ensure that sponsors have sufficient time to prepare a comprehensive and legally sound protocol submission for assessment. The SPA process allows the sponsor to discuss the design and planned analysis of the trials with the FDA before the trial begins, ensuring that critical aspects meet the necessary scientific and regulatory standards.

The timeframe is important because it facilitates thorough review and feedback from the FDA. It allows both the agency and the sponsor to clarify expectations and requirements, minimizing the risk of misalignment regarding study objectives.

The other options reflect shorter durations that do not align with the established regulatory standards, which emphasize the need for a more extensive review period to ensure the rigor and integrity of the clinical trial design before initiation.