ACR634

Implement clinical quality control measures.

Manage the risks to the conduct and completion of a study as well as the safety, health, and well-being of subjects.

Develop, implement, and evaluate corrective and preventive actions (CAPA).

Manage adverse events, protocol deviations, and safety issues.

Describe monitoring and auditing processes, how they differ, and how to use them to help assess and ensure clinical trial safety and compliance.

Differentiate between critical clinical research advisory boards, including a Data Safety Monitoring Board (DSMB) and a Clinical Events Committee (CEC).

Manage negative information, including communication to and from regulatory bodies, ethics review committees, investigators, subjects, and internal and external stakeholders.

Explain the requirements of clinical trial registration.