SOCRA CCRP Practice Exam

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Which responsibility is NOT listed for monitors per ICH GCP 5.18?

  1. Ensure investigator and staff adequately trained/informed

  2. Provide financial support to the trial

  3. Verify protocol compliance

  4. Report recruitment rate

The correct answer is: Provide financial support to the trial

One responsibility not listed for monitors per ICH GCP 5.18 is providing financial support to the trial. This is because the role of a monitor is to oversee and ensure the conduct of the trial, rather than provide financial support. The other options listed, A, C, and D, are all responsibilities that are included in the ICH GCP guidelines for monitors. They involve ensuring proper training and communication with the investigator and staff, verifying protocol compliance, and reporting recruitment rate.

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