To document informed consent, which documents are described as used?

• A. Signed Protocol and Amendments and Sample CRF
• B. Informed Consent Form only
• C. Financial agreement document
• D. Advertisement for recruitment

Answer: (A)

The main idea here is how consent is evidenced in a study. Informed consent is documented by the signed Informed Consent Form, which shows that the participant received the study information, understood it, and agreed to participate. This form includes the participant’s signature and date, and the person who obtained consent signs as well. The protocol with its amendments and the sample CRF are study documents that describe how the study is conducted and how data are collected, but they do not serve as evidence that consent was given. Financial agreements and recruitment advertisements are not the documents used to document consent. Therefore, the appropriate document to document informed consent is the Informed Consent Form.