Advanced Course in Medical Coding (MedDRA & WHODD) in Clinical Trials

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. Hence medical coding is required by using standardized medical dictionaries. The two main dictionaries used for coding are MedDRA and WHODD. AEs (Adverse Events), SAEs (Serious Adverse Events), MH (Medical History) and CM (Concomitant Medication) are generally coded. The coding tool which is integrated with CDMS is Thesaurus Management System(TMS).

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Created By Cliniversity Global Last Updated Sun, 17-Mar-2019 English
What will i learn?
  • Learner's / aspirants will get a practical understanding of how the medical coding is performed in the clinical trial's using the standard Medical Coding dictionaries (MedDRA & WHODD) and understand the significance of medical coding in Clinical Data Management and Statistical Data Analysis.

Curriculum for this course
0 Lessons 00:00:00 Hours
Requirements
  • Doctor's (BDS, BAMS, BHMS, BUMS, MBBS)
  • B.Pharm, M.Pharm, Master's ( Biotechnology, Biochemistry, Microbiology, Bioinformatics etc..)
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Description
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.
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