2010-11-23 RCRIM Call Minutes
Return to RCRIM Teleconference Minutes and Agendas
RCRIM Call Minutes
|HL7 RCRIM Meeting Minutes
Location: Location: Dial: 770-657-9270 Passcode: 745896#
|Facilitator||Ed Tripp||Note taker(s)||Ed Tripp|
|X||Joel Finkle||Image Solutions, Inc.|
|X||Ed Tripp||Edward S. Tripp and Associates|
|Quorum Requirements Met: YES|
|quorum for RCRIM is 10 plus a co-chair|
- Agenda review and approval
- No changes or additions to the agenda
- 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
- 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.
- Project Reviews
- 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.
- 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
- Clinical Trials Registration and Results
- There were no representatives on the call. This will be moved to the next agenda
- 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.
- 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).
- BRIDG as DAM
- Adjourned 10:55 am Eastern.
|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
- Agenda review and approval
- Approve meeting minutes from 2010-11-23_RCRIM_Call_Minutes
- Project Update on Clinical Trials Registration and Results
- BRIDG as the RCRIM DMIM
- Mission and Charter Review
- Other Items
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