User Guide for E2E meta data management Project

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Project Overview

The project will be initiated in June and intends to develop a practical guide on how to implement clinical metadata management within an organization (including use cases and data standards governance framework). The project will gather a set of requirements for metadata management tools that fulfill the needs for an E2E process within an organization, as well as support data consistency for cross-trial analysis. At a high level, an E2E lifecycle means from Trial Design upstream through Submission downstream. The particular processes involved within each lifecycle stage will be identified during project execution, to the extent this is needed. This 12+ months project will initially meet bi-weekly for one hour, (opposite weeks from the Metadata Definition project), for the first three months)

Project Leads

Name Role Organization E-mail
Terek Peterseon Industry Co-Lead PRA International PetersonTerek@PRAIntl.com
Jason Industry Co-Lead

Project Members

Name Organization E-mail
Terek Peterseon PRA International PetersonTerek@PRAIntl.com
Yun Oldshue Takeda yun.oldshue@takeda.com
Barry Cohen Accenture barry.r.cohen@accenture.com
Marcelina Hungria Dicore Group mhungria@dicoregroup.com
Kenneth Stolzfus Accenture kenneth.m.stoltzfus@accenture.com
Julie James Blue Wave Informatics julie_james@bluewaveinformatics.co.uk
John Leveille d-wise jleveille@d-wise.com
Laura Kelly Quintiles Laura.Kelly@Quintiles.com
Gregory Steffens Novartis Pharmaceutical Corp. Gregory.steffens@novartis.com
Praveeb gard IconPlC Praveen.Garg@iconplc.com
Eileen Gardenhire Celgene egardenhire@celgene.com
Steve Ward Eli Lilly stw@lilly.com
Greg Fuller fuller.greg@gmail.com
John Hunter hunterjohnr@gmail.com

Project Updates

Teleconference: Will be Kicked Off in June 2013
WebEx Details:
Call-in Numbers:


Objectives and Timelines

Project Activities


Meeting Materials

Date Document Type Document



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