Certified Clinical Research Associate (CCRA) Practice Exam 2026 – All-in-One Guide to Master Your Certification!

For expedited reporting of an adverse event by the Sponsor, an investigator's assessment indicating that the event is 'possibly related' is crucial. This assessment signifies that there might be a connection between the adverse event and the investigational product or study intervention. Regulatory guidelines and sponsor obligations typically require that any event with a potential association to the study product be reported quickly to ensure participant safety and regulatory compliance. By receiving a 'possibly related' designation, the Sponsor can take necessary actions, such as notifying regulatory authorities or initiating further investigations, thereby maintaining participant safety and the integrity of the study.

In contrast, if the investigator assesses the event as 'not related,' it does not warrant expedited reporting since it implies that there is no connection to the clinical study. Compliance with previous studies alone does not dictate the necessity for expedited reporting, as each event should be evaluated based on the context of the current study. Lastly, the Sponsor’s own assessment is relevant for other reporting purposes, but expedited action is driven primarily by the investigator's evaluation of potential relationships.