CRCM Final Competency Assessment
Equivalent in difficulty to the baseline, with deeper scenarios. Submissions enter independent human review. Training completion alone never results in verification.
5 scored items, 90 minutes.
- Regulatory and GCP judgment 25% of the scoreICH GCP principles, applicable regulations and sponsor or IRB obligations.
- Informed consent and participant protection 20% of the scoreConsent process, re-consent, vulnerable participants and documentation.
- Source documentation and data quality 20% of the scoreSource records, query handling, ALCOA principles and timeliness.
- Safety reporting 20% of the scoreAdverse events, serious adverse events, causality language and timelines.
- Professional communication 15% of the scoreWritten clarity, escalation to the right party and factual tone.
Site-to-CRA Final Competency Assessment
Equivalent in difficulty to the baseline, with deeper monitoring scenarios. Submissions enter independent human review. Completion of training alone never results in verification.
5 scored items, 90 minutes.
- Monitoring strategy and visit conduct 25% of the scoreVisit preparation, monitoring plan adherence, SIV, IMV and COV activities.
- Source data review and verification 20% of the scoreSDR and SDV judgment, sampling, and what a finding actually is.
- Deviations, CAPA and escalation 20% of the scoreClassifying deviations, root cause thinking and correct escalation.
- Investigational product accountability 15% of the scoreAccountability records, storage excursions and reconciliation.
- Trip reports and follow-up 20% of the scoreFindings written so a reader can act, with clear ownership and dates.
