SOCRA CCRP Practice Exam

What are an investigator’s responsibilities regarding the protocol?

1. Develop study protocol, Conduct trial per FDA 1572, Submit protocol changes

2. Report adverse events, Protect subjects, Obtain informed consent

3. Ensure IRB compliance, Maintain records, Properly train staff

4. Ethical assurance, Financing assurance, Publication rights

The correct answer is: Report adverse events, Protect subjects, Obtain informed consent

The investigator's primary responsibilities regarding the protocol center around the safety and rights of the study subjects, which is clearly reflected in the correct answer. Reporting adverse events is crucial as it ensures that any unexpected or harmful effects experienced by participants are communicated promptly, allowing for necessary adjustments to be made to protect participants and the study's integrity. Protecting subjects is a fundamental responsibility that encompasses various aspects of the research process, ensuring their well-being and ethical treatment throughout the study. Obtaining informed consent is also a critical element, as it involves providing potential participants with comprehensive information about the study, allowing them to make an informed choice about their participation. In terms of the other options, while they each contain important aspects of an investigator's role, they do not specifically focus on the protocol's responsibilities in the same way. Developing the study protocol and conducting trials per FDA 1572 is certainly part of an investigator's role, but these tasks extend beyond mere protocol compliance. Ensuring IRB compliance, maintaining records, and properly training staff are also essential responsibilities but again do not directly relate to the protocol in the ethical and subject-focused context that the correct answer addresses. Ethical assurance, financing assurance, and publication rights, while relevant in the broader scope of research, do not