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

An investigator must promptly notify the trial participants and the regulatory authorities if a clinical trial is prematurely terminated or suspended. This is crucial for several reasons.

First, notifying trial participants is essential to ensure their safety and well-being. Participants have volunteered for the study and have a right to understanding the reasons for the stoppage, especially if it may affect their health or ongoing treatment. Providing them with clear communication helps maintain trust and allows them to make informed decisions regarding their health care moving forward.

Second, informing regulatory authorities is a requirement under clinical trial regulations to ensure transparency and accountability. Authorities need to be aware of any changes in the trial status to monitor compliance with regulatory standards and to protect the integrity of the clinical research process. Regulatory bodies may also have the responsibility to oversee the continuation of participant safety and to investigate the reasons behind the termination or suspension.

While notifying the media might be important for public disclosure in some circumstances, it is not typically a priority or requirement in the immediate context of a trial suspension. Similarly, while the sponsor and funding agency should be informed, the requirement emphasizes the notification of trial participants and regulatory authorities due to their direct interest and concern in the outcomes and safety involved. Thus, this dual notification ensures proper management and resolution of issues surrounding