The terms to be coded in any project get coded by a process known as “auto coding”, the terms which fail to get “auto-coded” have to be coded “manually” by medical coder responsible for the project. Ideally coding is performed on validated and cleaned data by data managers responsible for “Data Review and Discrepancy Management”.
Prior to assigning a dictionary to a project/study, it is essential to check the following points as a prerequisite: If the same version of dictionary is to be used for any another project/study in future, then UAT needs to be repeated by members on the operational team assigned to the new project / Study. Once the operational team clears UAT, the selected dictionary is released for use for a particular project/study. After ensuring correct import tables and records in the tool by the programming team, the operational team performs user acceptance test (UAT) in which the members of operational team confirm that the dictionary which is loaded in the tool is giving the required output as expected. This process is performed only once for the given version of dictionary. Once the dictionaries are imported / loaded in the appropriate tool the programming team checks if all the tables/records are correctly loaded in the tool. In respect of Oracle Clinical (OC) the coding tool used is Thesaurus Management System (TMS). However coding AEs, SAEs and CM is mandate in any given clinical trial.Īny medical coding dictionary and all subsequent revisions have to be correctly imported / loaded in the appropriate coding tool by the database programming team. 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.
#Pharmaceutical dictionaries trial
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.
#Pharmaceutical dictionaries license
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