2010-11-23 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: 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: 2010-11-23 Time: 10:00-11:00 am Eastern Time
Facilitator	Ed Tripp	Note taker(s)	Ed Tripp
Attendee	Name	Affiliation
X	Becky Angeles	ScenPro
X	Isabelle Dezegher	Parexel
X	Julie Evans	CDISC
X	Joel Finkle	Image Solutions, Inc.
X	Patricia Garvey	FDA
X	Norman Gregory	FDA
X	Ed Helton	NCI
X	Jay Levine	FDA
X	Steve Sandberg	ScenPro
X	Ed Tripp	Edward S. Tripp and Associates
X	Anmol Wassan	Virtify
X	Geoff Williams	Roche
Quorum Requirements Met: YES
quorum for RCRIM is 10 plus a co-chair

Agenda

2010-11-23 RCRIM Call Agenda

Supporting Documents

1. File:RCRIM Decision Making Practices v2.2.doc

Minutes

Minutes/Conclusions Reached:

1. Agenda review and approval

   No changes or additions to the agenda

2. Approve meeting minutes from 2010-10-26 Teleconference October 26, 2010

   Note: 'Only notes were taken for call on 2010-11-09 and no approval is necessary 2010-11-09 RCRIM Call Minutes

   Motion by Joel to approve the minutes, seconded by Norman.

   Motion approved unanimously

3. Review and approval of Decision Making Practices

   Geoff suggested that we add a reference for Roberts Rules of Order.

   Motion was made by Norman and seconded by Joel to approve the Decision Making Practices with the amendment to add a reference for Robert Rules of Order.

   Vote: 7 for/0 against/3 abstain

   Following the teleconference, Ed Tripp updated the DMP and provided it to HL7 HQ. The document has been posted to the website RCRIM Decision Making Practices V3.0.

4. Project Reviews
   1. BRIDG as DAM

      The next version of BRIDG will be balloted by through the JIC by both ISO and HL7. The HL7 ballot will take place in the May ballot cycle. The ISO ballot will open in December. Included in the ballot will be ICSR, SDTM and the response to comments from the prior ballot.

      There was a discussion about harmonization of Study Design and Subject Data that were planned for the 2011 ballot per the BRIDG as a DAM Project Scope Statement. Due to the fact that the ISO ballot materials will go to ballot in December, it does not look like there is sufficient time to complete the harmonization process. It was agreed that we should target to complete harmonization by the first quarter 2011 so the material will can included in the May 2012 ballot. Jay will work with the BRIDG Board of Directors to assure appropriate priority with respect to other harmonization projects.

      There was a discussion on the harmonization process and it was agreed that the RCRIM “BRIDG Harmonization Process and Procedure” document would be reviewed during this processed and necessary updates identified.

      The BRIDG Board of Directors election process is currently open for nominations. The nominations will close the last day of November and the election will take place at the December BRIDG Board Meeting.

   2. CDISC Content to Message

      The ballot materials for the Implementation guides for Study Design and Study Participation will not be ready for the current ballot cycle. Ed Tripp will request a postponement of the ballots. It is expected that Study Participation will ballot in May and Study Design in May or September.

      It is reported that Gunther is confident that CDAr2 can be used for Subject Data. The project scope statement should be amended. Patty will amend the scope statement to reflect an implementation guide for CDAr2 in place of the ballot for a Subject Data document.

      Testing of the DSTU’s continues using the FDA X-Forms. Participation is open and any company wishing to participation in the submission of Study Design or Study Participation Data should contact Patty Garvey

   3. Clinical Trials Registration and Results

      There were no representatives on the call. This will be moved to the next agenda

   4. Medical Product Information (SPLr5)

      Myron Finseth provided an update via e-mail. The status is unchanged and the DSTU continues. There is concern with the impact of ITSr2. Keith Thomas and Gunther are working with the ITS Work Group to address the concerns.

   5. Regulated Product Submissions

      Geoff reported that October 2010 marked the end of the requirements phase of RPSr3. The plan is to move to ballot as a DSTU in May 2011.

      RPSr2 testing has been underway for about 6 months. Phase I of the testing has completed and Phase II is exploring additional scenarios. If additional requirements are uncovered in the Phase II testing a decision will have to be made to either postpone the May ballot or ballot in May and receive those requirements as ballot comments.

      Input from Devices has been limited but there has been increased activity with the Global Harmonization Task Force (GHTF).

• Adjourned 10:55 am Eastern.

Meeting Outcomes

Action Item	Owner	Due Date
Amend and Publish RCRIM DMP v3.0 Document	Ed Tripp	2010-11-23
Request postponement of Study Design and Study Participation IG Ballots	Ed Tripp	2010-11-23
Amend Project Scope Statement for CDISC to Message	Patty Garvey	2010-12-07

Next Meeting Preliminary Agenda Items

1. Agenda review and approval
2. Approve meeting minutes from 2010-11-23_RCRIM_Call_Minutes
3. Project Update on Clinical Trials Registration and Results
4. BRIDG as the RCRIM DMIM
5. Mission and Charter Review
6. Other Items

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