Why This Course Matters

Clinical research depends on high-quality data to support regulatory submissions, product approvals, and evidence-based decisions. CDM professionals play a pivotal role in data collection, validation, discrepancy resolution, database lock, and compliance.

What You’ll Master

Module 1 — Introduction to Clinical Data Management

• Purpose of CDM and its role in clinical research


• CDM process and lifecycle overview


• Key terminology and role definitions


• Regulatory bodies and compliance standards

Module 2 — Clinical Trial Fundamentals

• Phases of clinical research and data flow


• Interaction between clinical teams and CDM


• Stakeholders: sponsors, CROs, investigators, RCAs

Module 3 — Data Management Planning

• Data Management Plan (DMP) essentials


• Designing a compliant DMP


• Documentation practices for audit readiness

Module 4 — CRF & Database Design

• Principles of CRF and eCRF development


• Database architecture and setup


• Variables, edit checks, and workflow considerations

Module 5 — Data Collection & EDC Tools

• Electronic Data Capture (EDC) systems and workflows


• Source verification and data entry best practices


• Multi-site data coordination strategies

Module 6 — Data Validation & Cleaning

• Edit checks and validation rules


• Query generation and resolution


• SAE and external data reconciliation

Module 7 — Quality, Compliance & Standards

• Regulatory compliance (e.g., ICH-GCP, 21 CFR Part 11)
  
  
• Audit trails, SOPs, and quality control workflows


• CDISC standards introduction (SDTM, ADaM)

Module 8 — Database Lock & Reporting

• Finalizing clinical datasets for analysis


• Database lock (DBL) procedures


• Archiving and data retention practices