Which statement best describes a monitor's responsibility regarding informed consent?

• A. Verifying that the sponsor approves all consent forms
• B. Verifying that written informed consent is obtained before each subject's participation
• C. Ensuring consent is documented only once per subject
• D. Verifying that consent forms are stored without dates

Answer: (B)

The fundamental idea is that the participant must give written informed consent before any trial-related procedures occur, and that this consent is properly documented. A monitor’s job is to verify that the consent process happened for each subject—signatures and dates present, and the form used is the one approved by the ethics committee—so that participation is truly voluntary and based on an understanding of the study. This means consent isn’t something checked once and then forgotten; it must be in place before every subject’s participation and remain appropriate if the study changes or procedures are added. It’s not the monitor’s role to confirm sponsor approval of consent forms, since those forms are ethics-approved documents, and it’s not acceptable to document consent only once or to store forms without dates, both of which would undermine the integrity and traceability of the consent process.