RPS Project Notes24112009

RCRIM |

Date: November 24, 2009 Time: 12:00 PM EST – 1:00 PM EST HL7 Telecon: 770-657-9270 Participant Passcode: 745896 Webinar: http://www.mymeetings.com/nc/join.php?i=SA300482&p=RPS2&t=c

Agenda

1. Review Agenda

2. RPS R2 Activities

• Ballot Activities - January 2010 - Q1 Tuesday

• FDA is working on the code sets for RPS R2 DSTU Implementation; will feedback information to the RPS R3 activities; there has not been a decision made on RPS R2 testing for devices.

• Planning for DSTU – Implementation Activities

• RPS R2 DSTU - FDA has expressed interest to continue with the RPS R2 testing; RPS R3 will need to manage the risks that fall out of the RPS R2 DSTU implementation.

3. RPS R3 Planning Activities

• WGM Q4 Wednesday
  • Project Scope Statement
    • Project Sponsorship
    • ICH Requirements
    • Other Product – International Requirements
    • Regional Requirements

Current Scope Topics - Reviewed and pending comments

• Additional Information about the Submission
• Two-Way Communication
• Referencing
• Lifecycle (e.g., Application, Submission, Attribute/Metadata and Element)
• Implementation Requirements
• Miscellaneous (e.g., hierarchy, document groupings and order of files, broken links)

• Need to know how the product information is handled in R3; pending discussions. Currently RPS R2 references the CPM - CMET R_Product (same as ICSR standard)

• Need to discuss the broken link issues for RPS R3; this may be better understood with the implementation activities.

RPS R3 - European participation - interested in reviewing the project governance for the next release to put some structure around how R3 project is run. There needs to be a means for making decisions and resolving them on the project. If stakeholders have requirements they should bring them forth and shepard them through the process.

If stakeholders are interested in participating in R3 activities (e.g., requirements, leadership), they should contact Geoff Williams, Mark Gray, Joe Cipollina or Bob Birmingham. If there are any additional scope topics/requirements - please send them to the listserve or directly to Marti Velezis.

There may be some more international requirements from devices (via participation in GHTF); participation/engagement is still unknown, but something that should be tracked by the group.

Objective: To get the project scope statement drafted (and ready for approval) for the Atlanta WGM and a proposed general timeline for scope items known to date.

4. Questions?

Tentative Meeting Schedule

(Note – these may be either RPS R2 or RPS R3 related calls, yet to be determined)

December 8, 2009 – 7:30 AM EST – Agenda: Discussion about the Project Scope Statement and content required; Discuss Project Sponsorship and resourcing for R3;

December 22, 2009 - 12:00 PM EST – Agenda: Project Scope Statement Draft Review and Comments

January 5, 2009 – 7:30 AM EST – Agenda: TBD

January 18 – 21 – Phoenix WGM