All data generated in Clinical trials are ultimately subjected to further analysis. It is very essential that this data gets interpreted uniformly in a standardized format.Medical coding is performed in clinical trial using Standardised medical coding dictionaries.Data listed above like AEs, SAEs, MH , CM and any other category generally are coded. However coding AEs, SAEs and CM is mandate in any given clinical trial.
There are several standardized medical coding dictionaries in the market; however five dictionaries listed below are used for coding:
1. COSTART - Coding Symbols for Thesaurus of Adverse Reaction Terms
2. ICD9CM - International Classification of Diseases 9 Revision Clinical Modification
3. MedDRA – Medical Dictionary for Regulatory Activities
4. WHO-ART – World Health Organisation Adverse Reactions Terminology
5. WHO-DDE– World Health Organisation Drug Dictionary Enhanced
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.
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