Metadata Management

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Project Overview

In the FDA/PhUSE Annual Computational Science Symposium of March 2013 in Washington DC, the Emerging Technology working group was launched with two main areas of focus as a start: metadata management and Semantic Technology. The metadata management stream is looking for volunteers who will hopefully participate on these two closely-aligned projects:

  1. 1 Develop Common Definitions
  2. 2 Practical Metadata Management Implementation Guide - The second 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
Isabelle deZegher Industry Co-Lead Paraxel
Mitra Rocca FDA Co-Lead FDA

Projects Overview

Metadata Definition Project
User Guide for E2E meta data management Project

Objectives and Timelines

Objective Timeline
Metadata Definition July 2013
User guide for E2E metadata management October 2013

Project Activities

  • Metadata definition project: Kicked off on May 17, 2013

Meeting Materials

Date Presentations
18 March 2013 EmergingTechnologies-Metadata Management Prioritization Presentation

Archived Content