2011-01-04 RCRIM Call Minutes

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RCRIM Call Minutes

Meeting Information

HL7 RCRIM Meeting Minutes Location: Location: Dial: 770-657-9270 Passcode: 745896# Webex Info: NO WEBEX FOR THIS CALL		Date: 2011-01-04 Time: 10:00-11:00 am Eastern Time
Facilitator	Ed Helton	Note taker(s)	Ed Helton
Attendee	Name	Affiliation
X	Michael Brennan	Johnson and Johnson
X	Joel Finkle	Image Solutions, Inc.
X	William Friggle	Sanofi Aventis
X	Joel Finkle	Image Solutions, Inc.
X	Patricia Garvey	FDA
X	Scott Getzin	Lilly
X	Norman Gregory	FDA
X	Ed Helton	NCI
X	Bron Kisler	CDISC
X	Wayne Kubick	Phase Forward
X	Jay Levine	FDA
X	Andrew Marr	GSK
X	Steve Sandberg	ScenPro
X	Steve Ward	Lilly
Quorum Requirements Met: YES
quorum for RCRIM is 10 plus a co-chair

Agenda

2011-01-04 RCRIM Call Agenda

Supporting Documents
File:CTRR Project Update 20101215.pptx

Minutes

Minutes/Conclusions Reached:

1. Agenda review and approval

   An RPS Update was added to follow approval of the prior minutes

2. Approve meeting minutes from 2010-12-07_RCRIM_Call_Minutes

   Minutes were unanimously approved

3. Project Update on RPS

   Geoff Williams reviewed the results of the RPS Leadership Meeting

   1. Geoff briefly summarised the content of the e-mail and Jason gave some follow up comments from his point of ##:view as the lead modeller. His penlultimate comment was his concern that "there wasn't enough road" to allow ##:us to do all of the activities we need before the end of February deadline. His final comment was that there ##:is a draft model available based on his understanding of the requirements he has, the discussions have been to ##:clarify and confirm his understanding so that the model can be most accurately defined. A message with this ##:model was sent out by Jason on 13th December (attachment to the message with a zip file, MS Word file and a ##:Powerpoint).

      ACTION: Jason to recirculate this information.

   2. It was noted that reviewing the content of this message and attachments may give all people a btter view of what needs to be done. It may also help people identify areas that they wish to clarify understanding of within the model.

      ACTION: Interested parties should review materials to help identify areas for future discussion for clarification of requirements. Final prioritisation of these discussions will take place at the upcoming meetings (see later actions).

   3. The general feeling of the meeting was that we should still aim to keep to the project timelines and that every effort should be made to meet the May ballot deadlines. In particular, there was a concern that making a decision now to move the ballot to September might lose some of the focus we currently have and only lead to another discussion later in the year about exactly the same topic, except we would now be discussing our concerns about meeting the September ballot deadlines.

      DECISION: At this time, focus will be maintained on meeting the milestones and deadlines for the May ballot cycle.

   4. In order to meet the timelines, there was some discussion as to how to get the work done. As noted in the December 17th e-mail, the proposal was made to meet weekly, using the Leadership Team Meeting slots as well as the planned Working Group meetings. The question was asked as to whether we knew everything that needed to be done. Jason highlighted what has already been done by Geoff and himself to list items for inclusion in the RPS R3 modelling and this has been used as the basis for the Working Group discussions. However, it was acknowledged that more could be done.

      DECISION: The Working Group will now meet weekly on Tuesdays to continue discussions on the modelling and specification design

      ACTION: Jason volunteered to put together a list of everything he has access to and any gaps in terms of documentation (state transition descriptions, definitions, missing storyboards, etc.) with placeholders to be filled in and create an Excel list that can become the basis of a project list to show ownership and responsibility for work. Priorities and resolution can also be recorded. This will be circulated by close of business today (4th Jan).

      ACTION: All interested parties to review the Excel sheet for the next WG meeting on Jan 11th.

   5. To get the work done it is clearly understood that we must have a commitment of people's time and effort, particularly during this period to the end of February, but in general as well. RPS Working Group members should be using the Excel sheet as a means to help identify and document areas they can work on, documents that individuals can commit to writing and reviewing, etc. Some people will need to commit time to the periods between teleconferences to ensure that progress is made in documenting and moving forward discussions to deliverables.

      ACTION: All Working Group members are requested to help identify what they can commit to doing to ensure the deliverables are met.

   6. There was discussion on monitoring progress and the drop dead date for the decision to participate in the May ballot cycle. The ballot packaging work begins in Mid March and the decision not to ballot can be taken as late as a few days before the ballot is due to start (and this has been done in the past). However, there is prep work that needs to take place and a late withdrawal will result in wasted work. Ideally, we would make the decision before the start of the ballot package preparation, which is the end of February timeline we are working to. The proposal is, therefore, to use the Tuesday March 1st Leadership Team meeting to review the progress and make the decision over whether to ballot. It was pointed out that there should also be some interim monitoring of progress, so the meeting on Tuesday 1st February will also be used to review progress to date.

      DECISION Initial part of meeting on Tuesday 1st Feb to be used to review progress through first four weeks.

      DECISION RPS R3 Leadership Team meeting on Tuesday 1st March to be used to make final decision on whether to proceed to ballot in May cycle.

   7. It was pointed out that the ballot is a means to review and receive comments, so how good do we need to make the balloted materials if we are expecting a review and comments to be received. The counter argument is that we want to avoid putting out for ballot something that has known problems and we should understand the that extensive comments could lead to a delay as we would need to reballot the standard, something that would require more work than just delaying the initial DSTU ballot by four months to the next ballot cycle.

      DECISION: RPS R3 Leadership team to review level completeness of work in modelling at March 1st meetng and assess risk with proceeding to ballot.

   8. A question was asked as to whether any stakeholder groups needed consulting about this decision making. It was reiterated that it is a key role of the Leadership Team to represent the stakeholder groups and ensure that updates about the progress of the project are adequately communicated, along with any requests for feedback/input/follow up from within the stakeholder group.

      ACTION: representatives from the key stakeholder groups are asked to ensure that information about this meeting and the decisions and actions are communicated within your stakeholder groups and, if necessary, any feedback is brought back to the group.

   9. The question of a face to face meeting was raised. It is understood that this can be very effective at moving projects forward but it is also understood that this relies on getting the key contributors into a room at the same time. There is concern that travel is probably difficult to arrange at this short notice to ensure that these key people can get together. The prooposal was that we should stick to teleconference meetings unless opportunities present themselves otherwise. Note: this should not stop any small groups of individuals who can meet face to face from doing so, but they should be transparent to the group about doing so and recognise that any decisions taken will be subject to communication back to the wider group and their input.

      DECISION: To focus work on teleconferences

      ACTION: WG members to propose any possible times/opportunities when face to face meetings might be held

4. Project Update on Clinical Trials Registration and Results

   THe slide presentation under supporting materials above was reviewed

5. Agenda for May WGM
   1. RPS requested a work group session and a session for ballot reconciliation
   2. CTR&R requested a quarter to provide an update
   3. There was a request for an Educational Session details will be discussed on the next call
   4. Stability Session: Implementation Guide (corrections) and Validation Doc

      There is a question as to whether a Validation document should be balloted as an HL7 artifact.

   • Adjourned 11:00 am Eastern.

Meeting Outcomes

Action Item	Owner	Due Date
Amend Project Scope Statement for CDISC to Message	Patty Garvey	TBD Open from December

Next Meeting Preliminary Agenda Items

1. Agenda review and approval
2. Approve meeting minutes from 2011-01-04_RCRIM_Call_Minutes
3. Agenda for May WGM

   Continued discussion on Educational Session

4. Other Items

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