Ten domains, twenty competencies, twelve role families.

The ten domains

1. D01

   Participant Rights, Ethics, and Informed Consent

   • C01. Protect participant rights, safety, well-being, privacy, and confidentiality.

     Recognize and act on circumstances that could compromise voluntary participation, safety, privacy, confidentiality, or equitable treatment.

   • C02. Conduct or evaluate the informed-consent process.

     Apply approved consent requirements, confirm that consent precedes trial participation, identify consent defects, and escalate or remediate within role authority.

2. D02

   Protocol Interpretation, Eligibility, and Study Planning

   • C03. Translate the protocol and schedule of activities into operational requirements.

     Identify required procedures, time windows, dependencies, prohibited actions, decision points, and documentation expectations.

   • C04. Evaluate eligibility and protocol compliance.

     Apply inclusion and exclusion criteria, distinguish facts from unresolved questions, avoid unauthorized medical decisions, and document the appropriate determination or escalation.

3. D03

   Participant Safety and Safety Reporting

   • C05. Recognize and characterize safety information.

     Identify information requiring clinical evaluation, obtain role-appropriate detail, distinguish urgency, and avoid delaying participant protection.

   • C06. Escalate, document, and follow safety-reporting requirements.

     Use the protocol, investigator direction, sponsor process, and applicable requirements to support timely and traceable safety action.

4. D04

   Study Conduct and Operational Execution

   • C07. Perform or oversee trial activities according to approved requirements.

     Coordinate visits, procedures, vendors, participants, and staff while maintaining protocol and role boundaries.

   • C08. Manage operational exceptions and continuity.

     Recognize missed windows, unavailable resources, scheduling conflicts, process failures, and other exceptions; document and escalate them appropriately.

5. D05

   Source Documentation and Data Integrity

   • C09. Create or evaluate attributable and contemporaneous source records.

     Ensure that records support what occurred, who performed it, when it occurred, and how the information can be verified.

   • C10. Maintain accurate, complete, consistent, and traceable data.

     Apply appropriate corrections, preserve audit trails, reconcile discrepancies, and avoid obscuring original information.

6. D06

   Clinical Systems and Data Workflow

   • C11. Perform or oversee role-appropriate work in clinical systems.

     Use EDC, CTMS, eTMF, safety, randomization, document, or related systems within assigned access and procedural controls.

   • C12. Resolve data and document workflow issues.

     Investigate queries, missing data, inconsistent records, reconciliation gaps, access problems, and workflow exceptions without creating unsupported information.

7. D07

   Investigational Product, Device, and Specimen Accountability

   • C13. Maintain or evaluate custody and accountability.

     Apply requirements for receipt, storage, access, dispensing or use, return, destruction, shipment, and reconciliation.

   • C14. Recognize and respond to accountability exceptions.

     Identify excursions, discrepancies, missing records, broken custody, dosing or use concerns, and other exceptions; protect safety and evidence integrity.

8. D08

   Regulatory and Essential Records

   • C15. Maintain or evaluate required approvals and essential records.

     Confirm that records are current, complete, appropriately authorized, accessible, and consistent with trial conduct.

   • C16. Assess inspection and audit readiness.

     Identify material gaps, reconstruct the evidence trail, distinguish missing documentation from missing activity, and support timely remediation.

9. D09

   Quality, Risk, Monitoring, and Corrective Action

   • C17. Identify and prioritize quality risks and findings.

     Evaluate impact on participant protection, data reliability, protocol compliance, and trial continuity.

   • C18. Investigate causes and develop proportionate corrective and preventive action.

     Separate immediate correction from root cause, define ownership and due dates, and evaluate whether action was effective.

10. D10

    Communication, Collaboration, and Professional Judgment

    • C19. Communicate effectively with relevant trial parties.

      Tailor accurate, respectful, role-appropriate communication to participants, investigators, site staff, sponsors, CROs, vendors, and oversight bodies.

    • C20. Document and escalate decisions with professional judgment.

      Recognize the limit of personal authority, communicate uncertainty, preserve the decision trail, and escalate before risk becomes harm.