Certified Clinical Research Coordinator (CCRC) Practice Exam

Informed consent is documented by which of the following?

1. A verbal agreement

2. A consent binder

3. A written, signed, and dated informed consent form

4. An electronic signature

The correct answer is: A written, signed, and dated informed consent form

Informed consent is a critical component of clinical research, as it ensures that participants are fully informed about the nature of the study, including any risks and benefits, before agreeing to take part. The correct response indicates that informed consent is formally documented through a written, signed, and dated informed consent form. This document serves several important functions: it confirms that the participant has received and understood the relevant information, it provides a record of the consent for both the participant and the research team, and it upholds ethical standards and regulatory requirements. The written consent form is essential not just for legal and ethical transparency but also to protect the rights of the participants. A signed and dated document indicates that the participant has actively consented to participate in the study, which is vital in maintaining compliance with institutional review board (IRB) requirements and good clinical practice (GCP) guidelines. Alternative methods like verbal agreements or informal documentation do not provide the same level of assurance or accountability as a formal consent form. While electronic signatures may sometimes be considered valid in certain contexts, they still need to follow specific regulations to ensure compliance with policies regarding informed consent. However, the standard practice remains to utilize a written, signed, and dated consent form as the definitive means of capturing informed consent