Metadata Management - Call for Participation

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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:

  • Develop Common Definitions - The first project being initiated in May is about developing common definitions around metadata and related aspects across the industry. There is indeed a lot of confusion around what is operational and structural metadata versus master data, code list versus code systems and value sets. We intend to develop industry-wide definitions – to be potentially re-used in the FDA guidelines – with some concrete, practical example to help people introduce these concepts correctly within their organisation. This six-month project will initially meet bi-weekly for one hour, for the first three months
  • 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)

If interested in participating in the practical Metadata management implementation guide, please email: Terek Peterson: PetersonTerek@PRAIntl.com



Contact isabelle.dezegher (at) parexel.com