Regulatory Affairs Certification (RAC) Practice Exam

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Prepare for the Regulatory Affairs Certification (RAC) Exam. Use our study flashcards and multiple choice questions, each featuring hints and explanations. Enhance your readiness for the certification!

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What is the minimum time allowed to submit a request for a Special Protocol Assessment for a clinical trial?

30 days
60 days
90 days
120 days

The correct answer is: 90 days

The minimum time allowed to submit a request for a Special Protocol Assessment (SPA) for a clinical trial is 90 days before the planned start of the trial. This timeline is explicitly stipulated by the FDA to ensure that sponsors have ample opportunity to receive feedback on the trial design, endpoints, and analysis plans before the clinical trial commences. The SPA process is critical as it allows the FDA to provide binding agreements on the study design and clinical endpoints, thus contributing to the trial's efficiency and ensuring that the development program is aligned with regulatory requirements. Understanding this time frame is crucial for regulatory affairs professionals, as it impacts planning and coordination for submitting trials for review. Knowing the 90-day requirement allows sponsors to adequately prepare their submission materials and receive validation from the FDA, which is essential for regulatory compliance and successful trial outcomes.