There are 8 competency domains:
- Scientific concepts and research design: Knowledge of scientific concepts related to the design and analysis of clinical trials
- Ethical and participant safety considerations: Care of patients, aspects of human subject protection and safety in the conduct of a clinical trial
- Medicines development and regulation: Knowledge of how drugs, devices, and biologicals are developed and regulated
- Clinical trial operations: Study management, GCP compliance, safety management, and handling of investigational product
- Study and site management: Site and study operations
- Data management and informatics: How data are acquired and managed during a clinical trial
- Leadership and professionalism: The principles and practices of leadership and professionalism in clinical research
- Communication and teamwork: All elements of communication within the site and between the site and sponsor. Teamwork skills necessary for conducting a clinical trial.