2012-07-31 RCRIM Call Minutes

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Meeting Information

HL7 RCRIM Agenda Location: Dial: 770-657-9270 Passcode: 7485962# WebEx Info: Go to https://estripp.webex.com/estripp/j.php?ED=129183437&UID=0&PW=NNzQ1Nzg4NGZj&RT=MiM3 If requested, enter your name and email address. If a password is required, enter the meeting password: RCRIM		Date: 2012-07-31 Time: 10:00-11:00 am Eastern Time
Facilitator	Ed Tripp	Note taker(s)	Ed Tripp
Attendee	Name	Affiliation
x	Frank Faunce	Abbott Laboratories
x	Norman Gregory	FDA
x	Ed Helton	NCI
x	Jay Levine	FDA
x	Armando Oliva	FDA
x	Lise Stevens	FDA
x	Keith Thomas	i4i
x	Ed Tripp	Edward S. Tripp and Associates
x	Steve Ward	Lilly
Quorum Requirements Met: YES
quorum for RCRIM is 8 plus a co-chair

Agenda

Agenda Topics

1. Agenda review and approval
2. Review and Approve RPS ballot reconciliation
3. Review and Approve RPS Publication Request
4. Review and Approve Patient Narrative Ballot Reconciliation
5. Review Agenda for WGM for Baltimore

   RCRIM Working Group Meeting Agendas

6. Other Items

Supporting Documents
File:V3 RP R2 U2 2012JAN combined.xlsx

RPS Publication Request

File:Disposition on CDAR2 IG EXCTSD PATNARR R1 D1 2012JAN Consolidated 20120716-reviewed in meeting.xlsx

Minutes

Minutes/Conclusions Reached:

1. Agenda review and approval

   Ed Tripp indicated that he had received a request for changing the name of the RCRIM-CDISC list serve. If there is time this will be discussed under other items.

2. Review and Approve RPS ballot reconciliation

   Discussion began with item 76 in the spreadsheet that was marked as "Not Persuasive". Keith indicated that his understanding of the motion that was made at the Vancouver meeting was that all of his comments (item 64 through 77) were to be marked as referred and tracked and in this case referred and tracked means that it will be reviewed during DSTU and resolved prior to normative Ballot. After discussion it was agreed that all 14 ballot comments would be marked as referred and tracked with this explanation added to the disposition.

   A motion was made by Keith Thomas and seconded by Steve Ward to approved the ballot reconciliation with the amendments above.

   Affirmative 8

   Negative 0

   Abstain 0

   Motion Carries

   Ed Tripp will post the ballot reconciliation and request withdrawal of negatives.

3. Review and Approve RPS Publication Request

   A motion was made by Keith Thomas and seconded by Steve Ward to approved the publication request pending the posting of ballot reconciliation.

   Affirmative 8

   Negative 0

   Abstain 0

   Motion Carries

4. Review and Approve Patient Narrative Ballot reconciliation

   The workgroup began reviewing the ballot reconciliation package but it was determined that the dispositions are not complete. This information will be communicated with Mitra Rocca and this will be placed on a future agenda.

   There was not time to cover the remaining agenda items and they will be moved to a future agenda.

• Adjourned 10:55 a.m. Eastern.

Meeting Outcomes

Action Item	Owner	Due Date
Post ballot reconcilation	Ed Tripp	8/6/2012
Process Publication Request	Ed Tripp	8/7/2012

Next Meeting Preliminary Agenda Items

1. Agenda review and approval
2. Approve meeting minutes from 2012-06-05_RCRIM_Call_Minutes and 2012-07-31_RCRIM_Call_Minutes
3. Patient Narrative Ballot reconciliation
4. Review Balitimore Agenda
5. Consider name change to RCRIM-CDISC List Serv.
6. Other Items

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