RPS Meeting Notes 01052010
Return to RCRIM main page | Regulated Product Submissions
Date: Tuesday, January 5, 2010
Time: 7:30 AM EST – 8:30 AM EST
HL7 Telecon: 770-657-9270 Participant Passcode: 745896
Webinar: http://www.mymeetings.com/nc/join.php?i=SA300482&p=RPS2&t=c
Contents
Agenda
- Updates – Project Status for RPS R2 activities(e.g., ballot activities, next steps, etc.)
- Prep/Review for the RPS R3 Project Scope Statement presentation (see reminder below)
- January 2010 HL7 WGM Information – meeting times, agenda, etc.
- Other agenda items?
Discussion Notes
Updates – Project Status for RPS R2 activities
Post-Phoenix Meeting Schedule
- RPS R2 - periodic updates to the RPS [R3] Working Group Meetings
- Need to assess the RPS R2 Implementation planning activities to determine any overlap; FDA and PhRMA are discussing the planning necessary (e.g., identification of outstanding implementation needs) offline (to allow R3 activities to begin) - report of issues can be done at a periodic interval to the RPS WG.
- DSTU Testing - Vocabulary to test the RPS R2 will be a subset (e.g., select application types)
- Need to coordinate the final Vocabulary requirements and perhaps working in other groups to accomplish this e.g., ICH.
- Request meeting times for RPS meetings - proposals should sent to the listserve; 7:30 AM EST and 12:00 PM EST? The decision is that we will meet biweekly at 7:30 AM ET for 1.5 hours. Begin on January 26, 2010 with the biweekly schedule.
Ballot Materials
- Domain Model Walkthrough - This is not included in the ballot materials; there is a question whether or not the Informative DAM should have been posted along with the DSTU ballot. This will be discussed further at the RCRIM meeting. Information will be followed up following the RCRIM meeting.
Prep/Review for the RPS R3 Project Scope Statement
- Andrew Marr sent in some comments; need to add an example for lifecycle management; for hyperlinking (e.g., addressing links that are not linking to current documents) in place of broken links; NMV needs to be spelled out in the document.
- No other comments discussed.
January 2010 HL7 WGM Information
Meeting - Tuesday, January 19, 2010
- Q1 - Ballot Reconciliation
- Q4 - Planning - should focus on RPS R2 DSTU Planning and any DAM Ballot requirements (e.g., planning BRIDG Harmonization)
Note: There will be NO Virtual connectivity for the Phoenix meeting.
Note: Need to establish a telecon for RPS R3 Planning to occur after the working group meeting.
- Ad-hoc Meetings: Will establish an informal dialogue with HL7 and ISO experts to bring information (and a source) to the RPS WG regarding various paths to work/collaborate with ISO.
RASH Project Plan
Need to determine if this project should be worked in with the RPS WG
Will need to work with the RCRIM/Vocabulary (Bron Kisler)to understand what the Vocab group can offer; are there any international work being done that can be leveraged.
- Need to understand the ownership of terms/concepts (internationally)
- Need to identify other working groups that may be responsible for authoring the terms (note: across the product lines and regions)
Need to create a list of required controlled terminology that is needed (http://gforge.hl7.org/gf/download/docmanfileversion/5402/6783/RPS_Vocabulary.xls); need to recirculate the spreadsheet to discuss the vocabulary concepts for RPS. Action: please send any concepts that need to be created (i.e., value sets that do not exist today)
Need to identify ownership to one of the subgroups (e.g., R2-Implementation?)
Need to send the RPS Controlled terminology used last year for testing in EVS: http://gforge.hl7.org/gf/download/docmanfileversion/5401/6782/FDARPScodingv1.xls
or browse individual codes at: http://nciterms.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C79148