During the consent process, confirmation of the participant's identity must be completed in accordance with regulatory requirements.

• A. True
• B. Not required
• C. False
• D. Only for minors

Answer: (A)

Verifying the participant’s identity during the consent process is essential to ensure the right person is giving consent and that the consent is valid under regulatory and ethical standards. Regulators and ICH GCP guidelines expect that the person signing the consent form is the actual participant or their legally authorized representative, and sites often implement identity checks as part of this process. This helps protect participants and maintain the integrity of the trial. Therefore, this statement is true. It’s not limited to minors or optional, and it isn’t false.