SOCRA CCRP Practice Exam 2025 – 400 Free Practice Questions to Pass the Exam

The responsibility for ensuring that investigators and staff are appropriately trained falls primarily on the clinical trial manager or clinical research associate (CRA). These roles are essential in overseeing the conduct of the study, ensuring compliance with regulatory requirements, and fostering a thorough understanding of the study protocols among the staff.

The clinical trial manager or CRA is often involved in developing training plans and materials, organizing training sessions, and ensuring that the training is comprehensive and effective. They assess the staff's understanding of the protocol, Good Clinical Practice (GCP), and other relevant guidelines, making it critical for compliance and the overall success of the trial.

While sponsors have a role in providing resources and guidelines for training, and the principal investigator is ultimately responsible for the conduct of the study, the direct oversight and organization of training are key tasks designated to the CRA or clinical trial manager. In contrast, the FDA does not take on the role of training staff directly, as their focus is on ensuring that the regulatory framework is followed rather than overseeing training procedures.