Pooling WHODrug B3 Format
In a March 2015 Federal Register Notice, the FDA encouraged sponsors to provide WHODrug Dictionary codes for concomitant medication data in investigational studies provided in regulatory submissions. The request indicated that codes should include the drug product trade name (where available), the active ingredient(s) and the Anatomical Therapeutic Chemical (ATC) Class. As indicated in the May 2015 Data Standards Catalog, the expectation for it's requirement begins March 2018. Additional information was provided in the October 2015 Study Data Technical Conformance Guide. Other regulatory agencies have communicated similar notices. In order to facilitate the population of active ingredients, the Uppsala Monitoring Centre, who maintains the WHODrug Dictionary, updated the dictionary (B3 and C3 formats) to improve the structure for multi-ingredient drugs. While this change will greatly improve the efficiency of reviewing, analysing and reporting medication data, it introduces several challenges when creating an integrated database.
This project team will create a white paper outlining best practices for creating an integrated database with medication data collected in different formats (B3 format and whatever format was applied previously).
Project Leadership Team
|Marlo Searcy||Project Co-Leader||Genentech||searcy.marlo (at) gene.com|
|Joyce Leflar||Project Co-Leader||Janssen Pharmaceutical Companies of Johnson & Johnson||JLeflar (at) its.jnj.com|
|Wendy Dobson||PhUSE Project Co-ordinator||PhUSE||wendy (at) phuse.eu|
- This project kicked off in September 2017. Please contact one of the project co-leads to be added to the meeting invite.
Objectives and Timelines
|Draft White Paper (Recommendations for Pooled Submissions with WHODrug B3 Format)||March 29, 2018|
|Final White Paper||Target June 2018|
Project Content and Activities
UMC WHODrug B3/C3 Implementation Guide
UMC How to use WHODrug for compliance with CM domain in the CDISC SDTM standard
FDA Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Notices
FDA Data Standards Catalog Version 4.10
FDA Study Data Technical Conformance Guide October 2017