Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

What document must be updated if there are revisions to safety information during a clinical trial?

1. Study protocol

2. Informed Consent Document

3. Regulatory submission

4. Monitoring report

The correct answer is: Informed Consent Document

The informed consent document must be updated to ensure that participants are fully aware of any changes in safety information during a clinical trial. This document serves to inform participants about the risks and benefits associated with the study, and any revisions to safety data could directly impact their willingness to continue participation. Maintaining an accurate and current informed consent document is crucial in upholding ethical standards and ensuring that participants are making informed decisions based on the most recent and relevant information. If safety information changes, it is imperative that this information is communicated to participants promptly, as it may affect their understanding of the trial's risks. The study protocol primarily outlines the overall plan for the clinical trial and may not specifically require updates for minor safety information changes unless they impact the study design or objectives. Regulatory submissions are important but they pertain to the information sent to regulatory bodies for oversight rather than directly to the participants. Monitoring reports are focused on overseeing trial conduct and participant safety but they do not serve the purpose of informing participants directly about safety changes.