Ace the SOCRA CCRP Exam 2026 – Become a Clinical Superstar!

Question: 1 / 400

What are an investigator’s responsibilities regarding the protocol?

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

Report adverse events, Protect subjects, Obtain informed consent

The responsibilities of an investigator regarding the protocol primarily center on the protection and well-being of study participants. Reporting adverse events is critical as these may have implications for participant safety and require immediate attention and reporting to regulatory authorities and ethics committees. Protecting subjects aligns with the fundamental principle of ensuring their safety and rights throughout the research process, which is also reflected in the requirement for informed consent. Obtaining informed consent is essential as it ensures that participants are fully aware of the study's purpose, procedures, risks, and their right to withdraw at any time without penalty.

While other options mention certain important aspects related to research conduct, they do not focus as comprehensively on the direct responsibilities tied to the protocol in relation to participant welfare. Developments such as changes to the study protocol (mentioned in another option) do indeed fall under an investigator’s responsibilities, but they are secondary to ensuring participant protection and informed consent as the primary obligations.

Focusing on the safety and rights of participants is paramount in clinical research, making this the most appropriate choice for the investigator's core responsibilities regarding the protocol.

Get further explanation with Examzify DeepDiveBeta

Ensure IRB compliance, Maintain records, Properly train staff

Ethical assurance, Financing assurance, Publication rights

Next Question

Report this question

Subscribe

Get the latest from Examzify

You can unsubscribe at any time. Read our privacy policy