Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam 2026 - Free ACRP Practice Questions and Study Guide

Informing the Sponsor according to protocol is the first action an investigator must take when a Serious Adverse Event (SAE) occurs. The reason this is the correct first step is that the Sponsor has the ultimate responsibility for the oversight of the clinical trial and must be informed of any significant safety concerns immediately. The protocol typically outlines the specific timelines and procedures for reporting SAEs to ensure compliance with regulatory requirements and participant safety.

This prompt notification allows the Sponsor to take necessary actions, including assessing the impact of the SAE on the study, notifying regulatory authorities if required, and determining if any changes to the study protocol or additional safety measures are needed to protect participants. Ensuring that the Sponsor is informed promptly helps maintain the integrity of the clinical trial and supports the overall safety monitoring process.

Other actions, such as documenting the SAE in the case report, notifying trial subjects, or conducting a meeting to discuss the SAE, are important but typically follow the immediate notification to the Sponsor. These actions may be part of the subsequent response to manage the event appropriately within the context of the study.