CRC 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.