Good Clinical Practice (GCP) Practice Exam

The primary duty of a Clinical Research Associate (CRA) is to monitor the progress of clinical trials. This involves ensuring that the trial is conducted in compliance with the study protocol, Good Clinical Practice (GCP) guidelines, and regulatory requirements. The CRA plays a crucial role in overseeing the data collection process, verifying that the data being entered into the study database is accurate, and ensuring that the rights and welfare of trial participants are protected.

Monitoring responsibilities also include conducting site visits, identifying and resolving any issues that arise during the trial, and maintaining communication between the sponsor, the investigative sites, and the study team. This oversight is vital to maintaining the integrity of the clinical trial and ensuring that it runs smoothly and efficiently.

While conducting clinical trials, analyzing trial results, and recruiting participants are important aspects of clinical research, these tasks typically fall to other professionals, such as principal investigators, biostatisticians, or recruitment specialists. The CRA’s specialized focus on monitoring positions them as a critical point of oversight in clinical research projects.