2010-12-07 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: 2010-121-07 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	Norman Gregory	FDA
X	Jay Levine	FDA
X	Andrew Marr	GSK
X	Lloyd Mckenzie	Gordon Point Informatics
X	Steve Sandberg	ScenPro
X	Ed Tripp	Edward S. Tripp and Associates
X	Wendy Ver Hoef	Scenpro
Quorum Requirements Met: YES
quorum for RCRIM is 10 plus a co-chair

Agenda

2010-12-07 RCRIM Call Agenda

Supporting Documents
RCRIM Mission and Charter

Minutes

Minutes/Conclusions Reached:

1. Agenda review and approval

   No changes or additions to the agenda

2. Approve meeting minutes from 2010-11-23_RCRIM_Call_Minutes

   Minutes were unanimously approved

3. Project Update on Clinical Trials Registration and Results

   No project representation present on the call. This item will be moved to the next agenda

4. BRIDG as the RCRIM DMIM

   Lloyd has consolidated the RIM based portion of BRIDG. Lloyd walked the attendees through the model. It was noted that CMETs are referenced where the analysis model comes or DMIM comes from an area other than BRIDG such as clinical statement. Once RCRIM has all its current messages harmonized with BRIDG, the use of BRIDG as a DMIM will provided for a process where new message requirements can be added to BRIDG, expressed in RIM based semantics at the DMIM level and then constrained in the message for the given use case. This would provide for full traceability back to the analysis requirements.

   It was noted that there is a schedule for project harmonization to BRIDG that extends to May 2013. If RCRIM stays on schedule with the project, in two years the process described above can be used for all RCRIM messages.

   Lloyd noted that if and when we choose to use BRIDG as the RCRIM DMIM, there will be maintenance responsibilities that RCRIM will have to assume.

5. Mission and Charter Review

   Under ‘’’MISSION’’’ the paragraphs were amended to read as follows:

   The RCRIM Work Group supports the HL7 mission to create and promote HL7 standards by developing standards to improve or enhance information management during preclinical research , clinical research and regulatory evaluation of the safety, efficacy and quality of therapeutic products and procedures worldwide.

   The Work Group defines messages, document structures, terminology and semantics to support the systems and processes used in the collection, storage, distribution, integration and analysis of such information. The main areas of interest are Regulated Products and Regulated Studies generated as a result of protocol driven research in a regulated environment.

   It was recommended that the illustration be amended to indicate that the blue box labeled ‘’Example Topic Areas’’ be amended to indicate that this is the BRIDG domain.

   The paragraph below the illustration was amended as follows:

   The Work Group will facilitate the development of common standards for clinical research information management across a variety of organizations, including national and international government agencies and regulatory bodies, private research efforts, and sponsored research. The ultimate objective is to increase the availability of safe and effective therapies by improving the processes associated with regulated clinical research.

   A motion was made by Julie Evans and seconded by Wendy Ver Hoef to approved the ‘’’Mission and Charter’’’ with the amendments above.

   Motion was passed unanimously

6. Other Items

   It was agreed that there should be no meeting on December 21, 2010

   The first meeting in January will include work on the May Working Group Meeting Agenda

   We are still awaiting the amendment of the project scope statement for CDISC to Message. Jay will touch base with Patty and determine a new expected delivery date.

• Adjourned 11:07 am Eastern.

Meeting Outcomes

Action Item	Owner	Due Date
Amend and Publish RCRIM Mission and Charter	Ed Tripp	2010-12-08
Amend Project Scope Statement for CDISC to Message	Patty Garvey	TBD

Next Meeting Preliminary Agenda Items

1. Agenda review and approval
2. Approve meeting minutes from 2010-12-07_RCRIM_Call_Minutes
3. Project Update on Clinical Trials Registration and Results
4. Agenda for May WGM
5. Other Items

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