Regulatory Affairs Certification (RAC) Practice Exam

Which type of protocol is NOT eligible for a Special Protocol Assessment review process with the FDA?

1. A Animal carcinogenicity protocols

2. B Stability protocols

3. C Phase 3 protocols

4. D Dose ranging protocols

The correct answer is: D Dose ranging protocols

The designation of protocols eligible for a Special Protocol Assessment (SPA) by the FDA focuses on specific types of clinical trials that aim to provide essential data for regulatory submissions. The SPA is designed primarily for Phase 3 clinical trial protocols, which are critical for the evaluation of drug efficacy and safety. Phase 3 protocols, as indicated in the response option, are subject to SPA because they are typically the last significant stage of clinical testing before a drug is submitted for approval. They are constructed to confirm the findings from earlier phases and provide the comprehensive evidence necessary for regulatory review. On the contrary, protocols such as animal carcinogenicity studies, stability studies, and dose-ranging studies serve different purposes and are not designed for a regulatory submission as definitive evidence of a drug's efficacy or safety. Animal carcinogenicity protocols are generally associated with non-clinical safety assessments, stability protocols are related to the product's shelf life and storage conditions, and dose-ranging protocols help determine the optimal dosing for further studies rather than meeting the criteria for SPA. Thus, dose-ranging protocols are not eligible for the SPA review process, confirming that these studies do not provide the same level of clinical evidence necessary for regulatory submission consideration as Phase 3 clinical trials.