Best Practices for Metadata Documentation (define.xml versus reviewer’s guide)

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Project Overview

Our objective is to define best practices for documenting and describing dataset structures and contents within standard submission deliverables such as define.xml and the data reviewer’s guide, addressing common challenges, differences between reviewing agencies and divisions, and recommending quality assurance activities.

Project Deliverables

Project Leadership Team

Name Role Organization E-mail
Sandy VanPelt Nguyen Project Leader Pfizer sandra.vanpeltnguyen (at) pfizer.com
Kiran Bonda Asst. Lead inVentiv Health-Roche kiran.bonda (at) roche.com
Steve Wong Asst. Lead Cytel steve.wong (at) cytel.com

Project Members

Name Organization E-mail
xxxxx xxxxx xxxxx xxxxx [at] xxxxx
xxxxx xxxxx xxxxx xxxxx [at] xxxxx

Project Updates

We are currently drafting our white paper and are seeking volunteers to help write and/or review. We plan to have the draft paper prepared by the end of the year.

Objectives and Timelines

Objective Timeline
White Paper - Best Practices for Metadata Documentation Q4 2016
Recommendations for changes to reviewer's guide packages Q4 2016
Recommendations to define.xml working groups Q4 2016


Project Content and Activities

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Meeting Minutes