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
Jason Industry Co-Lead

Project Members

Name Organization E-mail
Terek Peterseon PRA International
Yun Oldshue Takeda
Barry Cohen Accenture
Marcelina Hungria Dicore Group
Kenneth Stolzfus Accenture
Julie James Blue Wave Informatics
John Leveille d-wise
Laura Kelly Quintiles
Gregory Steffens Novartis Pharmaceutical Corp.
Praveeb gard IconPlC
Eileen Gardenhire Celgene
Steve Ward Eli Lilly
Greg Fuller
John Hunter

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

Archived Content