Proposed MedDRA Changes

Thursday, 10 September 2015

Comments due by September 25

Proposed MedDRA Changes

The MedDRA Maintenance and Support Services Organization seeks user community feedback on a series of proposed changes to be included in an upcoming release. You can get more information about the changes by downloading the change proposal from this page

I recently posted about Apelon's new and improved DTS representation of MedDRA. In that post, I highlighted things I like about MedDRA and some things I don't like.

The change management process here is something I definitely like. The MSSO has carefully worked out what they want to do, explained the proposed changes in a clear document, and asked for feedback from their customers while there's still enough time for the feedback to be meaningful. While that level of care may seem like "overkill" if you're used to managing your terminologies in spreadsheets (and most of you do...admit it!), it's absolutely essential if your users depend on terminology content for documenting important stuff... like, for instance, drug safety!

Furthermore, the changes proposed are pulling MedDRA's terminology in the right direction. The most significant proposed change is to create a new top-level hierarchy for "product issues". The new tree will group together a lot of things that are currently stuffed under the "general" category, and expand detailed term coverage for product issues over time. Other changes include refinements to existing terms designed to increase precision. Incremental change for the better.

To me, these changes all seem positive, but I wonder about your experiences? Is there a strong argument out there against the proposed changes? Let me know if you hear one!

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John Carter