SOCRA CCRP Practice Exam

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What does a Phase 2 and 3 study protocol need to outline according to the FDA?

Detailed budget
Outline of study protocol
Endorsements
Insurance policies

The correct answer is: Outline of study protocol

A A detailed budget is not required to be outlined in a Phase 2 and 3 study protocol, as this is typically handled by the sponsor or project team responsible for funding the study. C: Endorsements are not a necessary component of a Phase 2 and 3 study protocol as they are not directly related to the research and scientific aspects of the study. D: Insurance policies also do not need to be outlined in a Phase 2 and 3 study protocol as they are not directly related to the study design and objectives. Overall, a Phase 2 and 3 study protocol should outline the specific details of the study design, methodology, and objectives, including timelines, inclusion and exclusion criteria, and data collection and analysis processes. This information is crucial in ensuring the safety and efficacy of the research and is required by the FDA for approval.