Meeting Minutes-DSTU-Testing Team 3-25-2010

Return to main Regulated Product Submissions Page

Attendees

Scott Becker, Merck; Bernadette Billet, Liquent; Bob Birmingham, Johnson & Johnson; Joel Finkle, ISI; Bill Friggle, Sanofi-Aventis; Jill Geist, Abbott; Mark Gray, FDA; Harv Martens, Extedo; Lenore Palma, Datafarm; Ragunathan Pathmanathan, Abbott; Kavitha Sivasubramanian, Independent; Sriram Thiruvengadam, Datafarm; Rich Ware, AstraZeneca

Discussion

Purpose

The purpose of this meeting was to provide introductions, identify the availability of RPS creation and consumption tools, and review the overall team objectives.

Tool Availability

Harv Martens, Extedo – indicated they are currently working with 2 customers on a creation tool. The timing for availability is not yet confirmed. The tool may also include validation capabilities.

Sriram Thiruvengadam, Datafarm – indicated they do not yet have a tool available, but do expect to have something in 2010. He will keep the team updated as we move through the testing phase.

Joel Finkle, ISI – indicated they currently have a tool to create simple RPS messages; additional development is being done to manage the full lifecycle capabilities. This will be made available to interested companies under a non-disclosure agreement.

Bernadette Billet, Liquent – indicated we have a tool to create basic RPS messages; it is being enhanced to handle the more complex lifecycle and 2-way communication available in RPS. A viewer is also in development.

Mark Gray, FDA – indicated he understands that GlobalSubmit will be providing FDA with a viewing tool, and current expectation is for availability in June 2010.

Bob Birmingham, J&J – indicated he understood Virtify and Octagon had also expressed interested in the testing team, but were not on the call. Bob will contact Virtify and Bernadette will contact Octagon to make sure they are aware of this team’s efforts.

Team Objectives

We reviewed that the purpose of this sub-team is to identify and provide the technical means to produce and review RPS messages. It is not intended as a vendor tool evaluation.

In the near-term the team needs to agree on the following in order to further develop the plan:

• Agreed interpretations – at a previous call there was discussion of Jason Rock providing a data model walkthrough. This will be important for this team to have a common understanding of the message requirements. This will lead to the creation of a draft implementation guide; Bernadette Billet and Lenore Palma volunteered to begin working on a structure for this. Bob Birmingham will follow up with Jason to see if this can be scheduled. If he cannot, Joel Finkle offered to provide this overview.

• Testing protocols – in addition to the test cases themselves, we need to define the methodology for message creation and exchange and technical acceptance criteria. It is understood that the process for creation of the message will vary by the tool being used, but we want to have standards for storing and exchanging information. It is not necessary to transfer messages using the FDA’s Gateway, it will be sufficient to store them in a central location from which other team members can retrieve them. The gForge site can be used for this purpose with links from the HL7 Wiki pages. Bob Birmingham will circulate instructions for creating a gForge account.

• Testing environments – these will be dependent on the tool being used, and it is expected that sponsors will partner with the different vendors to perform the actual testing. Joel noted post-meeting that it would be useful if sponsors could partner with multiple vendors; this will enable us to identify any areas of varied/conflicting interpretations and resolve them early. We would like to identify these partnerships as they are formed so we can ensure proper test coverage. Bernadette offered to compile and maintain this information.

• Validation criteria – minimal validation of the messages will be required to ensure they meet the technical acceptance criteria. We need to determine what these criteria are and how they will be executed. Additionally, we discussed the possibility of different application views. Without viewing tools that understand the RPS lifecycle, a current/cumulative view will be difficult to achieve, but will be important from the business perspective to ensure that the combined RPS messages display the intended view of the application.

Risks and Dependencies

It will be beneficial to have iterative reviews with the test cases produced by the test case team to identify any unclear areas and ensure a common understanding of the test objective. Joel and Bernadette have already met with the Test Case team leads and have schedule ongoing meetings for this purpose. The Controlled Vocabulary Team leads will also be added.

The Controlled Vocabulary team is developing information limited to the scope of the test cases. The format in which this is delivered will be important for use by the building and consumption tools. Currently, this is in Excel format, but a standard, machine-readable format may be preferred to enhance consistency. Harv Martens referenced the valid-values.xml file format used for study tagging files, suggesting this type of format may be appropriate and allow the different tools to have a common basis. Jill Geist offered to forward the current list with the understanding that it is still a work in progress. Joel Finkle offered to take a pass at translating into an XML structure that could be used for the DSTU phase. It is understood that the format agreed upon for this phase does not need to be the final implementation.

Action Items

Bob Birmingham to contact Virtify and invite them to join the team.

Bernadette Billet to contact Octagon and invite them to join the team.

Bernadette Billet and Lenore Palma to begin a draft a structure/content for an implementation guide, limited to the scope of the current testing phase.

Bob Birmingham to check if Jason Rock can provide the Data Model overview for the full team; if he cannot, this will be scheduled with Joel Finkle.

Bob Birmingham to provide instructions for activating gForge accounts.

Jill Geist to provide the current draft of the controlled vocabulary in Excel; Joel Finkle to review for potential conversion to an XML format.

All - as sponsor/vendor partnerships are established for testing, please forward that information to Bernadette Billet so we can track overall test coverage.

Bernadette Billet to forward ongoing meeting information for bi-weekly calls Thursday at 3:00 EDT, beginning 3/8/2010