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Meeting Minutes-DSTU-Testing Team 7-1-2010

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Harv Martens, Extedo; Lenore Palma, Liquent; Matthew Lukela, Otsuka; Mary Padgett, FDA; Bill Friggle, Sanofi-Aventis; Joel Finkle, ISI; Bob Birmingham, J&J; Aaron Grant, Liquent; Bernadette Billet, Liquent


Vendor Updates

  • ISI - has one client up and running with testing, 3 others in the process of setting up
  • Extedo - no change from previous communication; they are working with existing clients
  • GlobalSubmit - not present on call; update from previous DSTU call are working with 9 sponsors and 2 agencies
  • Liquent - given recent company updates are consolidating to a single product offering which is slated for availability in approximately 1 month; having conversations with some customers regarding testing
  • No other vendors were present on the call; Bernadette will attempt to get post-meeting updates

The Vendor Information document on gForge will be updated to include team member contact information to aid sponsors wishing to partner for testing.

Forum Discussions and Acceptance Criteria

There have been a number of posts on the RPS forum that have highlighted that there may be varied assumptions and/or interpretations of how the RPS XML messages will be constructed. Since we want all RPS messages consumable and validateable by all tools regardless of the tool used to construct them, the need for technical acceptance critiera to evaluate the samples produced is necessary. The team discussed adding information to the RPS Codes spreadsheet from the controlled vocabulary team that explicitly define the ContextofUse to Keyword dependencies, the submissionUnit code the Submission code dependencies, the appropriate method in the XML to reference another submissionUnit/Application from another submissionUnit and the appropriate method for indicating in the RPS XML that a single SubmissionUnit has applicability across multiple applications.

Bernadette will contact Mark Gray to discuss updating the RPS codes spreadsheet to include the known dependencies so that messages may be evaluated to ensure expected information is provided. Questions regarding referencing exist on the forum currently, but do need additional details. A new thread will be created to discuss the proper method for referencing another application in the RPS XML to ensure all tools have a common approach for referencing in the XML.

Wiki and gForge Information

The wiki does not automatically update links when a new version of a file is posted on gForge. This has caused review of some out-of-date files. A message will be sent to the subteams with instructions to udpate the wiki when gForge files are updated and a request to include "last Updated" information in the wiki description.