Good Clinical Practice (GCP) Practice Exam

What must a subject do to provide informed consent for participation in a clinical trial?

1. Sign and date a consent form

2. Discuss risks with the investigator only

3. Receive verbal consent without documentation

4. Meet with an ethics committee

The correct answer is: Sign and date a consent form

Providing informed consent for participation in a clinical trial is a crucial process that ensures the subject understands the nature of the study, including its purpose, procedures, risks, and potential benefits. The correct answer emphasizes the importance of obtaining a formal record of this understanding. When a subject signs and dates a consent form, they are indicating that they have received comprehensive information about the trial and have voluntarily agreed to participate. This documentation serves as evidence that the informed consent process was conducted properly and that the subject understood what participation entails. The use of a written consent form also helps protect both the rights of the subject and the integrity of the trial. The other options do not adequately fulfill the requirements of informed consent. Discussing risks with the investigator is part of the process, but it does not by itself constitute informed consent without the formal agreement documented in writing. Verbal consent without documentation is insufficient, as it lacks the necessary record to demonstrate that informed consent has been obtained in a way that is compliant with regulatory and ethical standards. Meeting with an ethics committee is essential for the oversight and review of the trial protocol but is not directly related to the individual subject's consent process. Thus, signing and dating a consent form is the appropriate action for ensuring informed consent is obtained.