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Difference between revisions of "RPS Meeting Notes 02092010"

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===Meeting Agenda===
 
===Meeting Agenda===
 
RPS R2
 
RPS R2
 +
 
- Feedback on the RPS R2 Ballot Reconciliation - Jason Rock
 
- Feedback on the RPS R2 Ballot Reconciliation - Jason Rock
 +
 
- Update on the DSTU testing - Bob Birmingham
 
- Update on the DSTU testing - Bob Birmingham
 
   
 
   
 
RPS R3
 
RPS R3
 +
 
- Walkthrough the draft Project Plan v0.2 document - Geoff Williams
 
- Walkthrough the draft Project Plan v0.2 document - Geoff Williams
 
  
 
===Meeting Notes===
 
===Meeting Notes===
Line 32: Line 34:
 
Jason presented the ballot reconciliation status - See presentation - TBD
 
Jason presented the ballot reconciliation status - See presentation - TBD
  
Would like to have all of the comments resolved by April 2010 to resolve the negative ballots.  There is still an outstanding issues with posting the DSTU -- is this going to put through the process to have it approved by the TSC for posting to the DSTU site (http://www.hl7.org/dstucomments/).
+
Jason stated that he would like to have all of the comments resolved by April 2010 to resolve the negative ballots.  There was discussion about submitting the paperwork to post the DSTU and it was determined that the RPS R2 DSTU will be put through the process to have it approved by the TSC and posted to the DSTU site (http://www.hl7.org/dstucomments/) once all of the negative ballot comments were resolved.
  
Jason will work with a small group and review the mass of the comments before presenting them back to the project status group.
+
Jason will work with a small group and review the mass of the comments before presenting them back to the project status group.  Note that there is a relationship to getting a "fixed" version of the DSTU materials to Bob and his team for testing, which will probably incorporate the one proposed model/schema change for the one to one CoU to file reference.  In addition, any changes made after the posting of the DSTU should be maintained by version control on the changes and posted for future reference.
  
 
====RPS R2 Update on DSTU Testing====
 
====RPS R2 Update on DSTU Testing====
Line 40: Line 42:
 
The project will continue with the DSTU testing while the DSTU comments are addressed and posted to the DSTU Site so that the Implementation group  
 
The project will continue with the DSTU testing while the DSTU comments are addressed and posted to the DSTU Site so that the Implementation group  
  
First meeting will take place on Tuesday, February 16, 2010 at 4:00 - 5:00 PM EST; this was not intended to exclude any participants, but be convenient
+
First meeting will take place on Tuesday, February 16, 2010 at 4:00 - 5:00 PM EST; this time slot was not intended to exclude any participants, but be convenient for the affected stakeholders.  The following workstreams need to be assigned to participants:
  
 
* Identify lifecycle sequences and test cases
 
* Identify lifecycle sequences and test cases
Line 47: Line 49:
 
* Work on skeleton of an Implementation Guide
 
* Work on skeleton of an Implementation Guide
  
Bob will be working on a high-level project plan posted by Friday, February 12, 2010.  Group needs assistance with the files necessary to extract the schema for use.  Jason will assist the group via email.
+
Bob will be working on a high-level project plan posted by Friday, February 12, 2010.  Bob indicated that the group needs assistance with the files necessary to extract the schema for use.  Jason volunteered to assist the group via email.
  
Change/Version control should be maintained after posting of the DSTU so that the schema can evolve will testing takes place.
+
Again, Change/Version control should be maintained after posting of the DSTU so that the schema can evolve will testing takes place.  Any changes to the content need to be posted and available by version.
  
 
Jason and Karin will discuss offline on the Context of Use change and its effect in Medical Device submissions.
 
Jason and Karin will discuss offline on the Context of Use change and its effect in Medical Device submissions.
Line 55: Line 57:
 
====RPS R3 Project Plan====
 
====RPS R3 Project Plan====
  
Geoff reviewed the project plan that was distributed on the Listserve. Overview of the document comments; the objective of the document is to address the description of the plans and how those plans may be achieved.
+
Draft distributed via Listserve and posted at: http://gforge.hl7.org/gf/download/docmanfileversion/5467/6908/RPSR3ProjectPlanv0-2.doc
  
There are several items that are still incomplete, please provide your comments as they will be fully populated in future versions.
 
  
Project Scope Statement was approved by the Technical Steering Committee - Woody Beeler (MnM) has asked to be contacted on the "hyperlinking" issue that is listed in the scope statement.  Ed Tripp will forward specific contact information to Geoff Williams.
+
Geoff reviewed the project plan that was distributed on the Listserve.  Geoff provided an overview of the document and its contents; the objective of the document is to address the description of the project plan and how those plans may be achieved. 
 +
 
 +
There are several items that are still incomplete, please provide your comments as the incomplete content will be fully populated in future versions.
 +
 
 +
Ed Tripp reported that the Project Scope Statement was approved by the Technical Steering Committee - Woody Beeler (MnM) has asked to be contacted on the "hyperlinking" issue that is listed in the scope statement.  Ed Tripp will forward specific contact information to Geoff Williams.
  
 
Success Criteria section still needs work, if there are specific items that need to be added, please sent comments.
 
Success Criteria section still needs work, if there are specific items that need to be added, please sent comments.
  
Deliverables - should there be a plan for validation (e.g., in the way of RASH); Need to add the proposed RASH project as a project dependency and need to provide a high-level description about what interactions need to take place during the RPS R3 project.
+
Deliverables - should there be a plan for validation (e.g., in the way of RASH)
  
The Wiki should documents should be stored on the gForge site (which has better document management), and linked on the Wiki for all project artifacts.
+
Dependency - Need to add the proposed RASH project as a project dependency and need to provide a high-level description about what interactions need to take place during the RPS R3 project.
  
Suggestion to make the RPS R2 Leadership as part of the Governance, to show the tight coordination.
+
The Wiki should document project activities with links to documents; and the gForge site (which has better document management) should be used for documents.  This should be added to the communication section of the project plan/project charter.
 +
 +
Mark Gray suggest to include the RPS R2 Leadership team as part of the Governance strategy, this will show the tight coordination between the two projects.
  
Bron Kisler should be approached as the Vocabulary Facilitator.
+
Bron Kisler should be approached as the Vocabulary Facilitator.  Ed Tripp will forward Bron's contact information to Geoff Williams.
  
 
Comment are welcome and should be sent to Geoff Williams by Friday, February 19, 2010.
 
Comment are welcome and should be sent to Geoff Williams by Friday, February 19, 2010.
Line 75: Line 82:
 
====Other Discussion Items====
 
====Other Discussion Items====
  
EU Regional requirements have been posted.
+
EU Regional requirements have been posted. Link to document: http://gforge.hl7.org/gf/download/docmanfileversion/5468/6909/RegulatoryActivityv03a.doc
  
 
Project Leadership Team (see Project Plan for list of participants) - query for the meeting times, any one who would like to contribute should contact Geoff.
 
Project Leadership Team (see Project Plan for list of participants) - query for the meeting times, any one who would like to contribute should contact Geoff.

Latest revision as of 18:59, 9 February 2010

Return to RCRIM main page | Regulated Product Submissions


Date: February 9, 2010

Time: 7:30 AM EST – 8:30 AM EST

HL7 Telecon: 770-657-9270 Participant Passcode: 745896

Webinar:

https://www.livemeeting.com/cc/pfizer/join

Meeting ID: 4F2SWM

Entry Code: RPS2010

Meeting Agenda

RPS R2

- Feedback on the RPS R2 Ballot Reconciliation - Jason Rock

- Update on the DSTU testing - Bob Birmingham

RPS R3

- Walkthrough the draft Project Plan v0.2 document - Geoff Williams

Meeting Notes

RPS R2 Ballot Reconciliation

Jason presented the ballot reconciliation status - See presentation - TBD

Jason stated that he would like to have all of the comments resolved by April 2010 to resolve the negative ballots. There was discussion about submitting the paperwork to post the DSTU and it was determined that the RPS R2 DSTU will be put through the process to have it approved by the TSC and posted to the DSTU site (http://www.hl7.org/dstucomments/) once all of the negative ballot comments were resolved.

Jason will work with a small group and review the mass of the comments before presenting them back to the project status group. Note that there is a relationship to getting a "fixed" version of the DSTU materials to Bob and his team for testing, which will probably incorporate the one proposed model/schema change for the one to one CoU to file reference. In addition, any changes made after the posting of the DSTU should be maintained by version control on the changes and posted for future reference.

RPS R2 Update on DSTU Testing

The project will continue with the DSTU testing while the DSTU comments are addressed and posted to the DSTU Site so that the Implementation group

First meeting will take place on Tuesday, February 16, 2010 at 4:00 - 5:00 PM EST; this time slot was not intended to exclude any participants, but be convenient for the affected stakeholders. The following workstreams need to be assigned to participants:

  • Identify lifecycle sequences and test cases
  • Establish tools - to work with the vendor community - to establish a framework for environment
  • Establish a controlled vocabularies and sample values
  • Work on skeleton of an Implementation Guide

Bob will be working on a high-level project plan posted by Friday, February 12, 2010. Bob indicated that the group needs assistance with the files necessary to extract the schema for use. Jason volunteered to assist the group via email.

Again, Change/Version control should be maintained after posting of the DSTU so that the schema can evolve will testing takes place. Any changes to the content need to be posted and available by version.

Jason and Karin will discuss offline on the Context of Use change and its effect in Medical Device submissions.

RPS R3 Project Plan

Draft distributed via Listserve and posted at: http://gforge.hl7.org/gf/download/docmanfileversion/5467/6908/RPSR3ProjectPlanv0-2.doc


Geoff reviewed the project plan that was distributed on the Listserve. Geoff provided an overview of the document and its contents; the objective of the document is to address the description of the project plan and how those plans may be achieved.

There are several items that are still incomplete, please provide your comments as the incomplete content will be fully populated in future versions.

Ed Tripp reported that the Project Scope Statement was approved by the Technical Steering Committee - Woody Beeler (MnM) has asked to be contacted on the "hyperlinking" issue that is listed in the scope statement. Ed Tripp will forward specific contact information to Geoff Williams.

Success Criteria section still needs work, if there are specific items that need to be added, please sent comments.

Deliverables - should there be a plan for validation (e.g., in the way of RASH)

Dependency - Need to add the proposed RASH project as a project dependency and need to provide a high-level description about what interactions need to take place during the RPS R3 project.

The Wiki should document project activities with links to documents; and the gForge site (which has better document management) should be used for documents. This should be added to the communication section of the project plan/project charter.

Mark Gray suggest to include the RPS R2 Leadership team as part of the Governance strategy, this will show the tight coordination between the two projects.

Bron Kisler should be approached as the Vocabulary Facilitator. Ed Tripp will forward Bron's contact information to Geoff Williams.

Comment are welcome and should be sent to Geoff Williams by Friday, February 19, 2010.

Other Discussion Items

EU Regional requirements have been posted. Link to document: http://gforge.hl7.org/gf/download/docmanfileversion/5468/6909/RegulatoryActivityv03a.doc

Project Leadership Team (see Project Plan for list of participants) - query for the meeting times, any one who would like to contribute should contact Geoff.

Next Meeting

Next Meeting - February 23, 2010 - Geoff will delegate a meeting facilitator in his absence.