SOCRA CCRP Practice Exam

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Who is responsible for ensuring investigators comply with GCP requirements?

  1. Investigators

  2. Sponsors

  3. FDA

  4. Regulatory Authorities

The correct answer is: Sponsors

Sponsors are responsible for ensuring investigators comply with GCP requirements. While investigators play an important role in conducting clinical trials, they are ultimately accountable to the sponsor. The FDA and regulatory authorities have oversight and enforcement responsibilities, but it is ultimately the sponsor's responsibility to ensure that their investigators are complying with GCP requirements. Therefore, options A, C, and D are incorrect.

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