CCRA Practice Questions - ACRP Certified Clinical Research Associate Exam

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During a routine monitoring visit, a CRA discovers that the investigator has not been reporting adverse events within the protocol-specified timelines. The CRA should FIRST:

Report the finding to the IRB/IEC directly Document the finding and discuss it with the investigator to understand the cause and develop a corrective action plan Immediately close the site to further enrollment Ignore the issue if the adverse events are not serious

Correct Answer:

Document the finding and discuss it with the investigator to understand the cause and develop a corrective action plan

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