ACRP-PM Practice Questions - ACRP Project Manager Exam

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A clinical research project manager discovers that a study participant was enrolled without providing proper informed consent. What should be the project manager's FIRST action?

Continue the participant in the study while documenting the oversight Immediately notify the IRB/Ethics Committee and the sponsor Remove the participant from the study without notification Wait until the next scheduled monitoring visit to address the issue

Correct Answer:

Immediately notify the IRB/Ethics Committee and the sponsor

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