Introduction to CODING

CODING is an application of the eClinical suite designed for the standardization of medical terms through precise coding using WHODrug and MedDRA dictionaries. The primary purpose of CODING is to translate verbatim terms into standardized dictionary terms to ensure consistency in medical data documentation within a specific clinical study.

Unlike the other eClinical applications, the CODING application is divided into two interconnected modules: Medical Coding and Coding Admin.

Figure 1. CODING application architecture

The Medical Coding module is a study-level system where users actually code medical terms within the context of specific studies, ensuring that all terms are standardized accurately according to the relevant medical dictionaries. In addition, users can manage coding batches to process multiple terms simultaneously, and generate delta change reports to track and document changes in coding over time, thereby maintaining a clear audit trail and ensuring data integrity.

The Coding Admin module, on the other hand, is an admin-level system designed for company-wide configuration management. From this module, administrators can set up and manage the configurations necessary for the studies' coding processes, including synonyms. This ensures that the Medical Coding module operates correctly and efficiently within the parameters defined by the organization.

Both modules are interdependent, working together to provide a comprehensive solution for medical coding.