Uniform Coding among Studies and Sites, and Analytical Reporting

The EDC system provides access to the Medical Dictionary for Regulatory Activities (“MedDRA”) and WHO Drug Dictionary Enhanced as provided by Uppsala Monitoring Centre (“UMC”) to facilitate coding of events and medications within a clinical trial. 

Highlights of this module include:

• Single-system consistency for all users with roles that are permissions based and flexible.
• Access new or legacy versions of MedDRA and WHO Drug dictionaries for easy up-versioning, a valuable feature for longer studies.
• Eliminate dictionary maintenance by managing the addition of new versions to the system.
• Help ensure codes align with FDA and regulatory requirements through updated dictionaries.
• Check entries against the dictionary and approved study coding using the auto-coding feature.
• Import synonym and auto-coding rules between study databases to maintain consistency and reduce coding efforts.
• Ease-of-analysis coding reports that enable new medical insights.