SOCRA CCRP Practice Exam

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Which regulation dictates that investigators and staff should be adequately trained?

  1. ICH GCP 5.14.3

  2. ICH GCP 5.18.4

  3. FDA 1572

  4. ICH GCP 5.1.1

The correct answer is: ICH GCP 5.18.4

All of the options listed refer to different guidelines and regulations related to clinical trials. However, only option B specifically addresses the requirement for adequate training for investigators and staff. Option A discusses the reporting of adverse events, option C refers to the submission of Form FDA 1572, and option D pertains to the qualifications of investigators. Therefore, option B is the most appropriate and relevant answer to the question.

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