Pooling WHODrug B3 Format

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Project Overview

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.

Project Deliverables

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

Name Role Organization E-mail
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 Manager PhUSE wendy (at) phuse.eu

Project Members

Name Organization E-mail
Amy Klopman Genentech klopman.amy (at) gene.com
Changhong Shi Merck changhong_shi (at) merck.com
Deb Bauer Sanofi deborah.bauer (at) sanofi-synthelabo.com
Diane Piper Shire dpiper (at) shire.com
Greg Campbell Gilead gregory.campbell (at) gilead.com
James Zuazo Chiltern James.Zuazo (at) chiltern.com
Shannon Labout CDISC Shannon.Labout (at) gmail.com
Siva Vobhilineni Biogen sivaprakash.vobhilineni (at) biogen.com
Sussan Kenny Maxlikelihood susankenny (at) maxlikelihood.com
Sybille Goetz ​​Boehringer Ingelheim sybille.goetz (at) boehringer-ingelheim.com
Vera Voloshin JNJ vvoloshi (at) its.jnj.com
Mercy Navarro Genentech navarro.mercy (at) gene.com
Laura Savard Beigene laura.savard (at) beigene.com
Lori VanMeter Janssen lvanmet (at) its.jnj.com
Malin Jakobsson Uppsala Monitoring Centre malin.jakobsson (at) umc-products.com
Mary Bethala-Pinninti Merck mary.a.bethala-pinninti (at) merck.com
Maryann Huffert Otsuka maryann.huffert (at) otsuka-us.com
Nikolaos Sitaridis Boehringer Ingelheim nikolaos.sitaridis (at) boehringer-ingelheim.com
Veena Nataraj Shire vnataraj (at) shire.com

Project Updates

  • This project kicked off in September 2017. Draft White Paper Recommendations for Pooled Submissions with WHODrug B3 Format Data were completed in April. The Final White Paper Recommendations for Pooled Submissions with WHODrug B3 Format Data were published in June. Please contact one of the project co-leads for any additional information.

Objectives and Timelines

Objective Timeline
Draft White Paper (Recommendations for Pooled Submissions with WHODrug B3 Format) March 29, 2018
White Paper Public Review May 1-31 2018, Closed
Final White Paper June 2018

Project Content and Activities

Reference Information

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

Meeting Minutes