Certified Clinical Research Associate (CCRA) Practice Exam 2025 – All-in-One Guide to Master Your Certification!

When an Investigator assesses an event as related to the study drug or intervention and the Sponsor disagrees, the Sponsor has an obligation to ensure that the event is reported appropriately. This includes expedited reporting because this assessment holds significance for patient safety and regulatory compliance.

Expedited reporting is required for serious adverse events that are determined to be possibly related to the investigational product, regardless of differing opinions on the relationship. The need for expedited reporting is rooted in the principles of ensuring participant safety and allowing regulatory authorities to monitor any potential risk associated with the investigational product.

While it might seem logical for the Sponsor to report the event as unrelated or downgrade the relatedness assessment, such actions could compromise patient safety and violate regulatory requirements that mandate full and transparent reporting of adverse events. Ignoring the Investigator's assessment would be irresponsible and could lead to severe consequences in terms of both ethics and compliance with clinical trial regulations. Therefore, the most appropriate course of action for the Sponsor is to ensure expedited reporting of the event, reflecting the importance of safeguarding participant welfare and providing accurate data to regulatory agencies.