Meeting Minutes-DSTU-Testing Team 5-6-2010

Attendees

Bob Birmingham, J&J; Rahul Mankad, Octagon; Sriram Thiruvengadam, Datafarm; Mary Padgett, FDA; Harv Martens, Extedo; Joel Finkle, Image Solutions; Jennifer Denomme, i4i; Jill Geist, Abbott; Lenore Palma, Datafarm; Mark Gray, FDA; Bernadette Billet, Liquent

Discussion

Data Model Presentation

The team discussed the data model presentation provided by Jason Rock and identified a number of additional items for which we require additional clarity. These include:

• setID usage rules
• Submission units with applicability/impact across multiple applications/submissions
• Lifecycle rules
• 2-way communication (challenges, handling threaded discussions, additional metadata requirements)
• Higher-level submission metadata requirements
• Controlled vocabularies: standard format, referencing, code usage rules, keyword dependencies, ordering of repeatable keywords, hierarchy

In some cases, these require additional discussion and agreement by the team; however, a number require additional clarification around the model itself. The list will be distributed to the team for priority ranking and consolidated. The consolidated ranking will be provided to Jason Rock with a request for additional follow up sessions to address these specific topics.

We discussed the possibility of jointly constructing a message using a standard XML authoring tool, such as XMLSpy to identify additional areas requiring clarification.

Sponsor-vendor Partnerships

Questions have been raised regarding what will be required in order to create these partnerships and how the testing itself will take place. We intend to capture the necessary information from each vendor so that sponsors have an understanding of how the partnerships with each vendor can be executed. As testing is executed, the partnerships will discuss the sponsor feedback to jointly determine what is tool-specific feedback, and therefore not relevent for the overall DSTU team and what is message-related feedback. In the case of any discrepancies, these will be escalated to Bob Birmingham as the Project Manager for resolution. Guidelines for what is construed general feedback vs. tool-specific will be agreed and distributed to the full team.

Action Items

• Bob Birmingham to distribute the link to Jason Rock's presentation and request the sample RPS XML referenced
• Bernadette Billet to distribute the technical clarifications list for ranking and return the consolidated list to Bob Birmingham
• Bernadette Billet to contact each vendor to testing protocols and feedback