Clinical Data Management Foundations for Trial Support Course
Master the end-to-end skills required to support clinical data management across the full trial lifecycle. This course covers everything from protocol interpretation and CRF design to EDC configuration, query management, and regulatory submission readiness. Whether you are entering the field or formalising your existing knowledge, you will gain the practical competencies that trial teams depend on.
4 to 360 hours flexible workload
valid certificate in your country
What will I learn?
You will learn how clinical data management operates within the regulatory framework of clinical trials, including Good Clinical Practice principles and data integrity requirements. The course walks you through protocol analysis, Data Management Plan development, and Case Report Form design. You will configure and validate Electronic Data Capture systems, write and test edit checks, and manage queries from generation to closure. You will also apply clinical data standards to produce submission-ready datasets and complete database lock and study closeout procedures. Advanced topics include risk-based quality management, external data integration, decentralised trial data handling, and emerging technologies such as AI-assisted data review.
Elevify advantages
Develop skills
- CDM Lifecycle Management: Execute every phase from study start-up through database lock.
- CRF and EDC Configuration: Design compliant case report forms and configure electronic data capture systems.
- Data Validation and Query Resolution: Build edit checks and manage the full query lifecycle to closure.
- Regulatory Submission Readiness: Map study data to standard domains and prepare define documents for agency review.
Suggested summary
Before starting, you can change the chapters and the workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.What our students say
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