What is the CRC's role in the informed consent process?

• A. Approve the consent form.
• B. CRC role in informed consent: Support process, ensure correct form, documentation, and understanding.
• C. Collect consent only for data collection.
• D. Review safety data etc.

Answer: (B)

The key idea is that the CRC is there to support the informed consent process, not to approve the form or act as the decision-maker. The CRC helps ensure the right, IRB-approved consent form is used, that the consent is properly documented (with signatures, dates, and any required witness or time-stamps), and that the participant (or legally authorized representative) truly understands what they are agreeing to. This means answering questions, confirming that the participant has the capacity to consent, and providing translations or explanations as needed so understanding is clear. The CRC also helps maintain the study records by recording how the consent discussion occurred and ensuring any changes or re-consents are documented.

This role does not involve approving the consent form—that responsibility lies with the ethics board or IRB and the study team to ensure the form is appropriate and approved. It also isn’t limited to collecting consent for data collection only, since consent to participate in the study encompasses more than just data collection. Nor is the CRC primarily responsible for reviewing safety data; safety review is handled by the PI and the sponsor’s safety oversight, with the CRC facilitating the process rather than performing the review.