SOCRA CCRP Practice Exam

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What are the responsibilities of an investigator as per 21 CFR 312.60?

Conduct investigation per protocol, Protect subjects, Obtain informed consent
Financing the study, Publication of results, Ethical assurance
Handling of data, Monitoring the study, Auditing
Training staff, Reporting adverse events, Ensuring IRB compliance

The correct answer is: Conduct investigation per protocol, Protect subjects, Obtain informed consent

One major responsibility of an investigator as per 21 CFR 312.60 is to conduct the investigation according to the approved protocol. This means following the study procedures and collecting accurate data. Option B is incorrect because financing and publication are not listed as specific responsibilities in 21 CFR 312.60. Option C is also incorrect because handling data and auditing the study are not mentioned as responsibilities for investigators under this regulation. Option D is incorrect because the training of staff and ensuring IRB compliance are not listed as responsibilities under 21 CFR 312.60. Another important aspect of an investigator's responsibilities is protecting the subjects' rights and welfare, as well as obtaining informed consent from them.