CCDM
Society for Clinical Data ManagementCertified Clinical Data Manager
The gold standard certification for Clinical Data Managers. Validates expertise across the full CDM lifecycle — from protocol review and CRF design to database lock and regulatory submission. Authored and curated by a practising CCDM-certified professional.
Exam Duration
3 hours
Exam Questions
100 MCQs
Passing Score
70%
Practice Q&A
70 Questions
Eligibility: 2 years CDM experience + relevant education (Bachelor's degree or higher in a scientific field)
Independent content. ClinPath is NOT affiliated with or endorsed by SCDM. CCDM® is a registered trademark of SCDM. This content is independently authored by a CCDM®-certified professional.
Practice Topics
3 free · 4 proClinical Data Management Fundamentals
FreeCore CDM concepts: DMPs, database lock, audit trails, data quality standards, and the CDM professional's role in clinical trials.
Protocol Review & CRF Design
FreeHow CDM reviews protocols, designs Case Report Forms, annotates CRFs, and creates data collection instruments that minimise errors.
Electronic Data Capture (EDC) Systems
FreeEDC system setup, validation (UAT), 21 CFR Part 11 compliance, role-based access, hard vs. soft edit checks, and CDASH standards.
Data Validation & Quality Assurance
ProRange checks, consistency checks, ALCOA+ principles, source data verification, risk-based monitoring, and CAPA management.
Medical Coding (MedDRA & WHO-DD)
ProMedDRA hierarchy, WHO Drug Dictionary, verbatim-to-PT coding, autocoders, version management, and ATC classification.
Regulatory Compliance & ICH Guidelines
ProICH E6 (R2) GCP, 21 CFR Part 11, GDPR, EU CTR 536/2014, Trial Master File requirements, and inspection readiness.
Safety Data & SAE Reporting
ProSAE criteria, expedited reporting timelines, SUSAR reporting, AE vs. ADR, SAE reconciliation, DSUR, and CDISC safety submissions.