Clinical Data Management (CDM) Online Course

Learn what the clinical data management system (CDMS) is, how vendors provide configurable tools with validation and SOPs, and how database design choices shape workflow.

Explore how medical coding translates clinical data into standardized terms using dictionaries like ICD-10 and MedDRA, enabling consistent safety and efficacy analysis for regulatory submissions.

Data capture compiles investigator observations from the clinical trial site into a centralized database, improving consistency and retrievability as technology advances enable remote entry and OCR-based automation.

Explore how clinical trial data are planned, collected, and captured using paper forms, electronic medical records, central web based systems, and electronic data capture, including patient-reported outcomes via handheld devices.

Data validation in clinical data management ensures high-quality data for regulatory decision making by validating source data against the eight characteristics of good clinical data.

Explore central, local, virtual, core, and specialty labs in clinical trials, and how data from labs is captured, managed, validated, and reported through queries, reconciliation, and CSR.

Learn how query management works in clinical data management, including auto, manual, coding, source data validation, and external queries, and how to frame clear, non-leading queries to resolve data inconsistencies.

This lecture explains the electronic case report form as the primary data collection instrument, detailing design, data flow, field placement, and testing to ensure high quality data.

Discover how quality management strengthens clinical data integrity through quality assurance, standard operating procedures, and audits that verify trial activities align with GCP and regulatory requirements.

Explore India’s regulatory system for drugs and devices, led by the central drug standard organization and ministry of health, detailing good clinical practice and the new drug approval process.