SOCRA CCRP Practice Exam

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Who is responsible for generating a trial protocol per regulations?

  1. Investigator

  2. Sponsor

  3. FDA

  4. ICH GCP

The correct answer is: Sponsor

A trial protocol is a document that outlines the objectives, methodology, and design of a clinical trial. It is a crucial document that must adhere to regulatory guidelines set forth by various organizations, including the FDA and ICH GCP. However, it is the responsibility of the sponsor to draft and develop the trial protocol. The investigator is responsible for conducting the trial according to the protocol, while the FDA and ICH GCP play a role in reviewing and approving the protocol. Therefore, the sponsor is ultimately responsible for generating the trial protocol per regulations.

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