SOCRA CCRP Practice Exam 2025 – 400 Free Practice Questions to Pass the Exam

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What are an investigator’s responsibilities regarding safety reports for drug studies?

Report SAEs immediately, Record and report non-serious AEs, Report SAEs to IRB

An investigator's responsibilities regarding safety reports for drug studies include reporting Serious Adverse Events (SAEs) immediately, recording and reporting non-serious Adverse Events (AEs), and reporting SAEs to the Institutional Review Board (IRB). Option B is incorrect because it does not mention the specific responsibilities regarding safety reports. Option C is incorrect because it focuses on the overall responsibilities of an investigator in a drug study, rather than specifically addressing safety reports. Option D is incorrect because it does not mention the reporting of SAEs to the IRB, which is a crucial responsibility. Therefore, A is the most accurate and comprehensive answer.

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Ensure IRB compliance, Develop ICFs, Submit protocol changes

Conduct study per investigational plan, Protect subjects, Obtain informed consent

Conduct according to current protocol, Train staff, Maintain adequate records

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