Which party is responsible for ensuring correct form and documentation related to consent?

• A. CRC.
• B. Principal Investigator alone.
• C. Sponsor only.
• D. Regulatory Authority.

Answer: (A)

The key idea is that the Clinical Research Coordinator at the study site is the person who handles the day-to-day management of informed consent documentation. This includes making sure the consent form version is the approved one, that the participant signs and dates all required fields, that any required witnesses are present, that a copy is given to the participant, and that the original is filed correctly in the trial records. The PI remains responsible for the overall conduct of the study and for protecting participants’ rights and welfare, but the practical task of ensuring the consent forms and related documentation are correct and complete is typically managed by the CRC. The sponsor provides the consent templates and monitors regulatory compliance, while regulatory authorities enforce rules rather than handling the documentation directly at the site.