When submitting a request for special protocol assessment, the sponsor should present targeted questions related to specific aspects of the protocol, such as its design (including the proposed size), study conduct, study objectives, and data analysis for the proposed investigation. While these questions should be directly related to the protocol and not encompass overall development strategies, it is important that the role of the study within the broader development plan is clear to the Agency, enabling them to effectively address the protocol-specific questions.

Read the original FDA guidance on Special Protocol Assessment requests.