Good Clinical Practice (GCP) Practice Exam

Monitoring in clinical trials primarily focuses on participant safety and adherence to the protocol. This ensures that the rights, safety, and well-being of participants are prioritized throughout the study. By actively monitoring clinical trials, sponsors and investigators can identify any deviations from the protocol, such as non-compliance with the treatment regimen or changes in participant health, and take appropriate actions to protect participants.

Additionally, monitoring helps ensure that data collected during the trial is accurate and reliable, thereby maintaining the integrity of the study. This is crucial for producing scientifically valid results that can reliably inform further research and clinical practice. Ensuring participant safety is not just an ethical obligation but also essential for achieving valid and trustworthy outcomes, as any adverse events need careful documentation and response.

While other options, such as ensuring budget compliance or finalizing study design, may play roles in the overall management of a clinical trial, they do not reflect the primary purpose of monitoring, which is fundamentally centered on safety and proper protocol implementation.