Medical coding is the classification of multiple similar verbatim terms, using a validated medical (or medication-based) dictionary supplied by the customer, or under licence by the relevant licensing bodies (MSSO, Uppsala), in order to produce a statistically quantifiable count of all similar terms in a given database.
Along with data entry, validation, data processing, reconciliation, external data load, and many more clinical data management related activities performed in Clinical Data Management systems (CDMS), medical coding is performed to facilitate the summarizing and analysis of certain sets of data (e.g. Adverse Events, Medical History records, Concomitant Medications etc.). To provide control and consistency, a variety of medical coding dictionaries may be used to process, analyse, and report collected data. The coded variables/terms are used by sponsors/medical monitors to review the events and medications throughout the study as appropriate.
Study statisticians and medical writing groups use the coding reports to get the quantitative numbers which is included in the corresponding sections of the TLFs (Tables, Listings & Figures) generated for the study which is eventually reflected in the Clinical Study Report (CSR) created for regulatory submission.
With multiple versions of medical dictionaries released by the managing bodies every year, processes must be established for managing the release of multiple versions of the same dictionary, handling different dictionaries or versions that have been used, and integrating data coded with different dictionaries or versions.