2013-03-12 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=221602147&UID=486590367&PW=NNDhmZTMwMTli&RT=MiM3 If requested, enter your name and email address. If a password is required, enter the meeting password: RCRIM		Date: 2013-03-11 Time: 10:00-11:00 am Eastern Time
Facilitator	Ed Tripp	Note taker(s)	Ed Tripp
Attendee	Name	Affiliation
x	Michael Brennan	Johnson and Johnson
x	Barry Brown	Mortara Instrument, Inc.
x	Myron Finseth	Medtronic
x	Norman Gregory	FDA
x	Ed Helton	NCI
x	Jay Levine	FDA
x	Lise Stevens	FDA
x	Ed Tripp	Edward S. Tripp and Associates
x	Mead Walker	Mead Walker Consulting
x	Steve Ward	Lilly
Quorum Requirements Met: YES
quorum for RCRIM is 8 plus a co-chair Agenda Agenda Topics Agenda review and approval Review and Approve WGM Minutes (see Supporting Documents) Review and Approve Updated Decission Making Practices (See Supporting Documents) Review and Approve aECG r2 Project Scope Statement (see Supporting Documents) Representation of PSS for Study Participation (see Supporting Documents) FROM Lynn Laakso In accord with the recent decision by the TSC to add a checkpoint of a re-presentation of the PSS for projects that were balloting normative (after DSTU, for example). This will be used by HQ as the notification point to ANSI for submitting our necessary paperwork. This approval is not required to go through the Steering Division. Ideally, it would be preferred to update your scope statement to the most recent template approved by the TSC From Ed Tripp, I have not updated the PSS to the new template but intend to get RCRIM approval to proceed to normative ballot and send a copy of the minutes to Lynn eStability IG update “errata document” Other Items Supporting Documents 2013-01-16 RCRIM Minutes Phoenix RCRIM Decission Making Practices 5.0 Continuous aECG Project Scope Statement PSS 205 CDISC to Message Minutes Minutes/Conclusions Reached: Agenda review and approval Ed Tripp indicated that if time permits we need to discuss revision of Mission and Charter. There was a suggestion to move the revision to the DMP first so that if someone drops we will still have quorum. Review and Approve Updated Decission Making Practices (See Supporting Documents) This revision to the DMP only changes the number of attendees from 8 plus a co-chair to 4 plus a co-chair. Mothion by Ed Helton, seconded by Mead Walker to approve the revised DMP. Vote: Affirmative - 9, Opposed - 0, Abstain - 0 MOTION CARRIES Review and Approve WGM Minutes (see Supporting Documents) Motion by Ed Helton, seconded by Mead Walker to approve the WGM Minutes from Phoenix Vote: Affirmative - 9, Opposed - 0, Abstain - 0 MOTION CARRIES Review and Approve aECG r2 Project Scope Statement (see Supporting Documents) Barry presented the aECG r2 Project. Minor revisions were made to the document. These are reflected in the document link aECG r2 Project Scope Statement v3 Motion by Mead Walker, seconded by Lise Stevens to approve the amended Project Scope Statement for aECG r2 Vote: Affirmative - 9, Opposed - 0, Abstain - 0 MOTION CARRIES Representation of PSS for Study Participation (see Supporting Documents ) Mead Walker will create a new Study Participation Project Scope Statement There was discussion on wether this would be balloted with Data types R2 or R2A This does not need to be resolved today but should be resolved before the ballot. If it is not, members are encouraged to make a comment to the ballot materials with respect to data types. Jay Levine agreed to develop a pros and cons list to the use of the two data types from an FDA perspective. This will be brought forward to the RCRIM membership for discussion at a future teleconference. Motion by Mead Walker, Seconded by Ed Helton to create a new PSS for Study Participation from the prior approved PSS. This will be formatted in the new template and forwarded to the TSC. Vote: Affirmative - 9, Opposed - 0, Abstain - 0 MOTION CARRIES eStability IG update “errata document” There is an errata document that can be used to amend errors and typos in implementation guides without reballoting the IG. This will be necessary for the eStability IG. Norman Gregory will prepare the document and send it out for inclusion in the agenda for our next teleconference. Other Items There was no time to address Mission and Charter. This will be moved to the next agenda. Adjourned 11:03 a.m. Eastern. Meeting Outcomes Action Item Owner Due Date Prepare Data Types pros and cons list for Study Participation J. Levine 3/26/2013 Prepare eStability Eratta Document for meeting on March 26, 2013 Norman Gregory 3/19/2013 Next Meeting Preliminary Agenda Items Agenda review and approval Approve meeting minutes from 2013-03-11_RCRIM_Call_Minutes Study Participation Data Types Discussion eStability errata document Mission and Charter. Other Items © 2010 Health Level Seven® International. All rights reserved.