A major part of the case management process is to ensure that every adverse event term is coded appropriately to the medical dictionary MedDRA.
Oracle’s Argus Safety makes coding verbatim terms quite simple. The system integrates very smoothly with the medical dictionaries MedDRA and WHO Drug. Per current MSSO Points to Consider (MSSO, 2014), adverse event terms should be matched to the most clinically appropriate lowest level term (LLT). The screenshot below (Classifying Medical Terms in Argus Safety) demonstrates the MedDRA Browser window in Argus Safety that allows a user to search the hierarchy of the MedDRA dictionary so that we may locate the appropriate LLT to select.
Classifying Medical Terms in Argus Safety
In addition to integrating with the drug dictionary WHO Drug, products are typically matched to the most appropriate medicinal product available in the WHO Drug Dictionary with the appropriate Anatomical Therapeutic Chemical (ATC) classification. The screenshot below (WHO Drug Browser) demonstrates the WHO Drug Browser window in Argus Safety that allows a user to search the hierarchy of the WHO Drug Dictionary, so that we may locate the appropriate medicinal product and ATC pair to select.
WHO Drug Browser
When a medicinal product has multiple ATC options attached, they are split up into separate lines, each referencing different routes of administration or indications of use (the concepts that loosely equate to different ATC options). The appropriate record and resulting ATC can be selected based on the appropriate clinical information in the case.
Additionally, in Argus Safety, there is a feature that allows you to locate and access a single entry screen displaying all of the case’s coding fields. This screen gives you the opportunity to perform all of the coding in one place without having to open up the case and go to each coding field on various tabs within the case.
Central event and drug coding interface is available without accessing the actual case entry form
This type of feature can be helpful to a central coding group that may be responsible for coding multiple cases at the same time. And, it’s also just a more pleasant way to view the case data when you have your coding hat on.
NOTE: Argus Safety can also integrate with any external dictionary management tool using web services. Oracle TMS and Cerner’s dsNavigator are two such options.
Visit our blog soon to learn about attaching files to cases in Argus Safety. And, feel free to register for our upcoming webinar Features of a World-Class Safety System.
To read past posts in our Argus Safety features series, click here.
References:
MSSO. (2014). Retrieved on January 7, 2015 from http://www.meddra.org/how-to-use/support-documentation
[pardot-form id=”34376″ title=”Life Sciences: 2015-1-29: Webinar BLOG Form: Features of a World-Class Safety System”]
