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)
Kiran Bonda Asst. Lead inVentiv Health-Roche kiran.bonda (at)
Steve Wong Asst. Lead Cytel steve.wong (at)

Project Members

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

Project Updates

Best Practices for Documenting Dataset Metadata: Define-XML Versus Reviewer’s Guide White Paper.

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