Clinical Data Management (CDM) & Electronic Data Capture (EDC)

Module 1: Introduction to Clinical Data Management

• Importance of Data Management in Clinical Trials
• Overview of CDM Processes & Life Cycle
• Regulatory Guidelines (ICH-GCP, FDA, EMA)

Module 2: Study Design & Case Report Form (CRF) Development

• Protocol & Study Design Basics
• Paper vs. Electronic Case Report Forms
• CRF Annotations & Database Design

Module 3: Data Collection & Electronic Data Capture (EDC)

• Overview of EDC Systems (Medidata, Oracle Clinical)
• Data Entry, Validation, & Query Management
• Ensuring Data Integrity & Security

Module 4: Data Cleaning & Quality Control

• Discrepancy Management & Query Resolution
• Data Validation & Edit Check Programming
• Database Lock & Data Freezing Procedures

Module 5: Regulatory Compliance & Audit Readiness

• FDA 21 CFR Part 11 Compliance
• Good Documentation Practices (GDP)
• Audit Trails & Inspection Readiness

Module 6: Career Opportunities & Industry Trends

• Roles in CDM & Career Pathways
• Future Trends in Clinical Data Management
• Certification & Training Programs