Certified Clinical Research Associate (CCRA) Practice Exam 2025 – Complete Preparation Guide

The appropriate response when reporting adverse events post-study is to file a report on causality and unexpectedness. This requirement is critical because it allows the Sponsor to assess whether the adverse events observed during the study may be related to the experimental treatment or intervention. By detailing causality, the Sponsor can evaluate whether the adverse event was expected given the known effects of the treatment or if it was an unexpected outcome that warrants further investigation.

This report is an essential component of post-study safety monitoring and helps ensure that any risks associated with the research are adequately communicated to regulatory authorities and stakeholders. By understanding both causality and unexpectedness, the Sponsor can also contribute to ongoing safety evaluations for the drug or intervention in question.

Other options, while related to research and clinical trials, do not meet the specific requirement for reporting adverse events. Patient feedback surveys focus on participant experiences rather than safety data. A clinical trial registry entry is primarily concerned with the initial registration and summary of study details rather than post-study adverse events. A financial audit report deals with the financial aspects of the study rather than safety and health-related outcomes.