This guide explains how to use the OpenClinica Code module within OpenClinica 4 for collecting and coding adverse event (AE) and medical event data.
MedDRA (Medical Dictionary for Regulatory Activities) is a standardized, hierarchical medical terminology used globally in clinical trials and pharmacovigilance. It standardizes terminology and enables consistent analysis and monitoring of medical events.
ℹ️ For more information on MedDRA, refer to the Official MedDRA website.
OpenClinica 4 supports the integrated medical coding of adverse events (AEs). This module enables both manual and automated coding of AEs. To use this feature, you must activate and configure it with valid MedDRA credentials. This functionality streamlines the coding process, ensuring faster, more accurate data entry and regulatory compliance.