Monday, January 25, 2016
Dear WHODrug User,
The dictionaries of WHODrug has been around for thirty years and has constantly evolved to meet users’ needs and modern standards. We are now at another critical stage in its development: WHODrug is now required or strongly recommended by leading national authorities for the reporting of concomitant medications in clinical trials and postmarketing safety surveillance.
It is a big step for all users and for us at UMC and due to this we are in the process of improving the product to further increase the analysis capacities for both industry and national authorities. We are now introducing an improved version of the B2- and C-formats: the B3 and C3-formats which are going to be released in March 1, 2017.
Everyone is convinced of the benefits, in terms of science and regulatory requirements, though we know it will demand careful planning and considerable resources. I and the UMC team hope to provide you and all our users with the best possible guidance and support for the transition.
Attached is a document describing the B3- and C3- formats. This document is accompanied by another: How to use WHODrug for compliance with CM domain in CDISC SDTM standard. These are the core texts for understanding and managing the upcoming changes.
There will be resources available to facilitate the transition, such as webinars and other UMC resources described in the implementation guide.
We hope you will feel confident joining us in this big step forward and will continue to keep us on the ball with your active involvement and feedback.
Malin Jakobsson and all of the WHODrug team of Uppsala Monitoring Centre
Please read our latest B3/C3 documents.