2011-12-06 RCRIM Call Minutes

Return to RCRIM Teleconference Minutes and Agendas

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: 2011-12-06 Time: 10:00-11:30 am Eastern Time
Facilitator	Ed Tripp	Note taker(s)	Ed Tripp
Attendee	Name	Affiliation
x	Julie Evans	CDISC
x	Norman Gregory	FDA
x	Ed Helton	NCI
x	Armando Oliva	FDA
x	Mitra Rocca	FDA
x	Steve Sandberg	ScenPro
x	Lise Stevens	FDA
x	Keith Thomas	i4i
x	Ed Tripp	Edward S. Tripp and Associates
Quorum Requirements Met: YES
quorum for RCRIM is 8 plus a co-chair

Agenda

Agenda Topics

1. Agenda review and approval
2. Approve meeting minutes from 2011-11-08 RCRIM Call Minutes
3. Review and Approve Harmonization proposals from RPS
   1. RPS Regulatory Category
   2. RPS Context of Use
   3. RPS Document Type
   4. RPS Keyword
   5. RPS Regulatory Status
4. Establish plan to generate BRIDG based Analysis Model for Study Design and Study Participation
5. BRIDG Ballot reconciliation
6. Review Agenda for WGM
7. Other Items

Supporting Documents

1. Harmonization Proposal - Regulatory Category
2. Harmonization Proposal - Context of Use
3. Harmonization Proposal - Document Type
4. Harmonization Proposal - Keyword
5. Harmonization Proposal - Regulatory Status

Minutes

Minutes/Conclusions Reached:

1. Agenda review and approval

   added discussion of CIC PSS for Schizophrenia Domain Analysis Model

2. CIC PSS for Schizophrenia Domain Analysis Model

   Anita Walden from CIC has requested RCRIM support and potentially co-sponsorship on this project scope statement. All the co-chairs support this and recommend that RCRIM request that we be co-sponsors but also that joint sessions be established so both WG's can participate in the development of the DAM

3. Approve meeting minutes from 2011-11-08 RCRIM Call Minutes

   Vote to approve Minutes 7 Affirmative, 0 Opposed, 1 Abstain. Minutes are approved.

4. Review and Approve Harmonization proposals from RPS

   Keith Thomas walked the group through each of the 5 harmonization proposals

   1. RPS Regulatory Category
   2. RPS Context of Use
   3. RPS Document Type
   4. RPS Keyword
   5. RPS Regulatory Status

   Motion by Ed Helton, seconded by Norman Gregory to approve all 5 harmonization proposals. Motion unanimously approved.

5. Establish plan to generate BRIDG based Analysis Model for Study Design and Study Participation

   Currently Study Participation is nearly complete while Study Design struggles due to the reference to the clinical statement CMET and the breadth of the CMET. It was agreed that work on Study Design should wait for until after the working sessions at the January WGM. Study Participation needs a modeler to complete the remaining mappings. Becky Angeles will work with Mead Walker and Lise Stevens to schedule this work in the appropriate priority relative to other modeler work on this project.

6. BRIDG Ballot reconciliation

   Julie has finalized the ballot reconciliation. The spreadsheet needs to be reviewed and approved by RCRIM. Julie will provide Ed with the finalized spreadsheet and RCRIM will vote to approve the reconciliation at the next teleconference on December 20, 2011

7. Review Agenda for WGM

   Mitra asked for more time on the agenda for CDA IG Ballot reconciliation. Due to moving the CTR&R presentation there is an open slot on Q3 Monday. Ed will tentatively schedule CDA IG for patient narratives in that slot and await confirmation from Lise and Mitra

8. Other Items

• Adjourned 11:00 a.m. Eastern.

Meeting Outcomes

Action Item	Owner	Due Date
Update WGM agenda for Q3 Monday	Ed Tripp	12/09/2011
Provide BRIDG ballot reconciliation Spreadsheet	Julie Evans	12/09/2011

Next Meeting Preliminary Agenda Items

1. Agenda review and approval
2. Approve meeting minutes from 2011-12-06_RCRIM_Call_Minutes
3. BRIDG Ballot reconciliation
4. Review Agenda for WGM
5. Other Items

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