Good Clinical Practice (GCP) Practice Exam

How is informed consent documented?

1. A verbal agreement documented by the investigator

2. A printed form that is signed and dated by the subject

3. Consultation notes detailing the subject's agreement

4. A witness statement affirming participation

The correct answer is: A printed form that is signed and dated by the subject

Informed consent is a critical component in clinical trials and research, ensuring that participants understand what they are agreeing to before participating. The correct documentation of informed consent is through a printed form that is signed and dated by the subject. This process serves several important purposes. First, the signed and dated printed form provides tangible evidence that the participant has received all necessary information about the study, including its purpose, potential risks, benefits, and alternatives, and that they agree to participate based on this understanding. It also signifies that the participant was provided an opportunity to ask questions and had that query addressed satisfactorily. Second, having a written document protects both the participant and the investigators. The participant’s signature indicates their voluntary consent, while the researcher has a legal and ethical record confirming that consent was obtained appropriately. Regulations often stipulate the necessity of a written informed consent as part of Good Clinical Practice (GCP) guidelines, as this practice helps to uphold the integrity of the research process and supports the rights and welfare of participants. While verbal agreements and consultation notes may provide insight into discussions between the investigator and subject, they do not offer the solid evidence that a signed form does, which is essential for compliance and for ensuring that participants can refer back to the disclosed information at