It is well known fact that these dictionaries come at a price and the organisations that perform medical coding activity should posses appropriate valid licences. However for a coder it is a challenging task to ensure that the term recorded/reported on data collection instrument (CRF/eCRF) is coded appropriately.

To maintain uniformity in reporting a term is next to impossible in any given clinical trial. Out of the above five, two widely used medical coding dictionaries used for coding medical terms generated in clinical trials are MedDRA and WHO-DDE. WHO-DDE - World Health Organisation Drug Dictio-nary Enhanced WHO-ART - World Health Organisation Adverse Reac-tions Terminology MedDRA - Medical Dictionary for Regulatory Activities ICD9CM - International Classification of Diseases 9 Revision Clinical Modification There are several standardized medical coding dictionaries in the market however five dictionaries listed below are used for coding:ĬOSTART - Coding Symbols for Thesaurus of Adverse Reaction Terms To describe process of medical coding and also to share some of the common problems that a coder faces during medical coding. To describe in brief two most extensively used dictionar-ies by most of the regulatory offices and majority of pro-fessionals in Pharmaceutical/CRO industry and

To explain how medical coding is performed in clinical trial using Standardised medical coding dictionaries. However coding AEs, SAEs and CM is mandate in any given clinical trial. Data listed above like AEs, SAEs, MH, CM and any other category generally are coded. Hence medical coding is required by using standardize medical dictionaries. It is very essential that this data gets interpreted uniformly in a standardized format. All data generated in these trials are ultimately subjected to further analysis. It is anticipated that due to involvement of investigators and clinical research professionals from different countries/region there is a possibility of recording medical/scientific data in different fashion. In a multicentric clinical trial there are many trial sites, which involve different investigator with different ethnic backgrounds. In these trials information on Adverse Events (AE), Medical History (MH), and Concomitant Medications (CM) used in addition to the study medication are collected and recorded on relevant DCIs. Data generated in all clinical trials is recorded on data collection instruments (DCIs) called as Case Record Forms / Report Forms (CRFs) in respect of paper based trials or as electronic Case Record/ Report form (eCRF) in respect of web based clinical trials.

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