SOCRA CCRP Practice 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
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

The correct answer is: 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.