The ten domains of the standard

Each domain has two competencies. Open one to see what it looks like on a normal working day.

• D01Participant Rights, Ethics, and Informed ConsentC01 Protect participant rights, safety, well-being, privacy, and confidentiality.C02 Conduct or evaluate the informed-consent process.
• D02Protocol Interpretation, Eligibility, and Study PlanningC03 Translate the protocol and schedule of activities into operational requirements.C04 Evaluate eligibility and protocol compliance.
• D03Participant Safety and Safety ReportingC05 Recognize and characterize safety information.C06 Escalate, document, and follow safety-reporting requirements.
• D04Study Conduct and Operational ExecutionC07 Perform or oversee trial activities according to approved requirements.C08 Manage operational exceptions and continuity.
• D05Source Documentation and Data IntegrityC09 Create or evaluate attributable and contemporaneous source records.C10 Maintain accurate, complete, consistent, and traceable data.
• D06Clinical Systems and Data WorkflowC11 Perform or oversee role-appropriate work in clinical systems.C12 Resolve data and document workflow issues.
• D07Investigational Product, Device, and Specimen AccountabilityC13 Maintain or evaluate custody and accountability.C14 Recognize and respond to accountability exceptions.
• D08Regulatory and Essential RecordsC15 Maintain or evaluate required approvals and essential records.C16 Assess inspection and audit readiness.
• D09Quality, Risk, Monitoring, and Corrective ActionC17 Identify and prioritize quality risks and findings.C18 Investigate causes and develop proportionate corrective and preventive action.
• D10Communication, Collaboration, and Professional JudgmentC19 Communicate effectively with relevant trial parties.C20 Document and escalate decisions with professional judgment.