UPDATED: This post was updated in 2019 to reflect new information and more examples. Enjoy!
Medical coding software is a crucial but often overlooked component to a research team’s technology toolkit. Simply put, it helps to ensure data being collected in a clinical trial, such as concomitant medications and adverse events, is being treated in a standardized way at every stage of the trial. Coding dictionaries serve as a solution to unify spelling, abbreviation, or other common errors that occur in the data collection process.
As an example, if one researcher reports an adverse event one way and another researcher inputs the same adverse event in a slightly different way, they can both utilize medical coding software to adjust the data to meet the standardized terminology. Additionally, if there are common terms being reported which do not have exact matches to a standard dictionary, coders can grow their own synonym dictionaries for using across studies.
Below, we take a look at the information on the latest version releases of the industry’s popular coding dictionaries, MedDRA and WHODrug, and what it means for users.
Things to know about the most recent MedDRA dictionary version
The purpose of the MedDRA dictionary is to classify and code adverse events (AEs) and serious adverse events (SAEs). This dictionary experienced a version release on March 1st, 2019 – Version 22.0. MedDRA Version 22.0 incorporated 1,333 user change requests. This includes approved changes to Standardized MedDRA Queries (SMQs) and added new a SMQ for Hypokalaemia. Additionally, the SMQ spreadsheet was updated.
Proactivity requests resulted in a more optimal placement for anesthesia terms in the dictionary, as well as more consistent placement for existing chemical burn and corrosive injury terms. Lastly, updates were made in relation to the rename provision, which allows for the modification of preferred terms (PTs) and lowest level terms (LLTs).
What about the most recent WHODrug dictionary version?
The purpose of the WHODrug dictionary is to classify and code concomitant medications. On March 1st, 2019, the B2/C formats were completely phased out and replaced by B3/C3 formats. WHODrug launched this new and improved dictionary format to better comply with CDISC SDTM standards. According to the Uppsala Monitoring Centre (UMC), the B3/C3 formats are introduced to facilitate regulatory submissions of WHODrug data in a format meeting regulatory CDISC SDTM expectations, without the need of any workarounds.
UMC has made this recommendation for WHODrug dictionary users: companies planning to submit study data (to the U.S. FDA or other regulatory agencies) are recommended to make use the B3/C3 formats as soon as possible, to meet regulatory SDTM expectations and benefit from the improvements of the new formats. So, it is crucial for medical coding professionals to have a tool that is compatible with the most up-to-date WHODrug format.
We can expect the launch of UMC’s WHODrug Koda on March 19th. Koda is an automated coding engine that leverages machine learning to achieve more efficient and accurate coding. Not only will Koda be available as a web application and as an add-on to WHODrug subscriptions, it also boasts an API, which will allow for integration with existing coding tools.
Replacing dsNavigator, a popular medical coding tool
Users of dsNavigator, the coding platform created by Cerner, learned that this tool would stop receiving updates and support after 2017, thus making it defunct. Since B2 and C WHODrug formats are officially unavailable for use (and not adopting new MedDRA versions), dsNavigator can no longer be considered an accurate and effective solution for coding professionals. This has led many companies to transition to a new coding platform that is certified with the medical dictionaries they need for their data collection and analysis.
TrialKit Coder, our medical coding solution
The team behind the TrialKit platform has created a medical coding solution that makes the process secure and swift. TrialKit Coder is a fast and powerful coding platform functioning entirely in the cloud. TrialKit Coder is available on any web browser or iOS device. This gives medical coders the ability to code and approve at any time, from any place.
TrialKit Coder also operates in two ways:
- Automatically integrated with TrialKit, the data collection and study management platform, and
- As a standalone platform for those who do not have a need for electronic data capture (EDC) technology, or who have data from any external source that is now in need of coding and standardizing. TrialKit Coder is a certified vendor with both MedDRA and WHODrug (B3 format) and adheres to CDISC STDM standards.