Data Collection, Monitoring & Data Management in Clinical Research

This course traces the flow of data from source to database lock. Learners explore source data collection, eCRF/CRF entry, validation, Source Data Verification (SDV), monitoring plans and responsibilities, clinical data management workflows, and introductory statistical analysis planning.

Course Benefits & Career Prospects

• Distinguish between source data, CRFs/eCRFs, and validated study databases.
• Perform or support Source Data Verification and query resolution.
• Understand monitoring plans, on‑site and remote monitoring activities.
• Follow basic clinical data management (CDM) workflows through database lock.
• Job placement assistance: data coordinator, monitoring support, or CDM trainee roles.

Modules

• Clinical Data Collection, Entry & Validation
• Source Data Verification (SDV)
• Monitoring Plan Development, Monitor Responsibilities & Site Monitoring Visits (SMV)
• Clinical Data Management (CDM) Workflow
• Statistical Analysis Plans (SAPs) & Fundamentals of Data Interpretation