NoyMed Academy Certified Data Manager
Own the clinical data lifecycle: CRF design, validation, query management, and database lock.
About this program
A full grounding in clinical data management: building the database, cleaning the data, and locking it for analysis.
Who it is for
Data coordinators, clinical programmers, and site staff moving into central data management.
Prerequisites
- Detail-oriented and comfortable with structured data
- Basic clinical trial knowledge
- Spreadsheet or database familiarity
Curriculum outline
1. The data management plan
Planning the data lifecycle.
Topics: DMP components · Roles · Timelines · System selection (EDC)
2. CRF and database design
Building the collection instrument.
Topics: CDASH-aligned CRFs · Edit checks · UAT · Go-live
3. Data cleaning
From data entry to a clean dataset.
Topics: Query management · Manual review · External data reconciliation · Medical coding (MedDRA/WHODrug)
4. Database lock
Freezing the data for analysis.
Topics: Lock checklist · SAE reconciliation · Soft vs. hard lock · Unlock procedures
5. Quality and standards
Keeping data management inspection-ready.
Topics: Audit trails · GCP for data management · Metrics
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