This wiki has undergone a migration to Confluence found Here
<meta name="googlebot" content="noindex">

Difference between revisions of "2010-11-23 RCRIM Call Minutes"

From HL7Wiki
Jump to navigation Jump to search
 
Line 70: Line 70:
 
|colspan="4" style="background:#f0f0f0;"|
 
|colspan="4" style="background:#f0f0f0;"|
 
|-
 
|-
−
<!-- *****  Delete instructions  and change quorum requirements ON NEXT LINE *****-->
 
 
|colspan="4" |'''Quorum Requirements Met: '''YES  
 
|colspan="4" |'''Quorum Requirements Met: '''YES  
 
|-  
 
|-  
Line 83: Line 82:
 
===Minutes===
 
===Minutes===
 
'''Minutes/Conclusions Reached:'''<br/>
 
'''Minutes/Conclusions Reached:'''<br/>
 +
#Agenda review and approval
 +
#:No changes or additions to the agenda
 +
#Approve meeting minutes from 2010-10-26 [http://www.hl7.org/Library/Committees/rcrim/minutes/2010-10-26_RCRIM_Call_Minutes.doc 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 [http://www.hl7.org/Library/Committees/rcrim/RCRIM_Decision_Making_Practices_v3%200.doc 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).
  
−
#''<font color="green">(Suggestions or additions to and acceptance of agenda)''</font>
+
*Adjourned 10:55 am Eastern.
−
#''<font color="green">(One efficient method used for meeting minutes is approval by general consent, of non-controversial topics like minutes when there are no corrections:  “You have received the minutes.  Are there any corrections to the minutes?  Hearing none, if there is no objection the minutes are approved as posted.”)''</font>
 
−
#<font color="green">(Discussion on agenda topic 3; ''If voting on ballot reconciliation item:''</font><br/> Agenda business is ballot reconciliation? Yes / No  <br/> Ballot reconciliation posted to ballot desktop? Yes / No <br/> If no, where is ballot reconciliation posted? ________________)<br/> '' if voting on ballot reconciliation, please indicate the votes are documented elsewhere, and note the item numbers from the spreadsheet, but you may document the actual vote tallies in the ballot reconciliation spreadsheet.''
 
−
#''<font color="green">Discussion on agenda topic 4;'' </font>'''Motion (if amended) can be retyped in bold.'''  Discussion on motion back to regular type.  '''Vote on Motion in bold''' <font color="green"> Identify the vote distribution across affirmative, negative, or abstention; numbers in format “for/against/abstain”, or ‘unanimous’.</font>
 
−
#<font color="green">''Discussion on agenda topic 5; if no conclusion reached and issue tabled to next meeting, add to ‘next meeting’ items below.  If action items are identified, add to ‘Actions’ below.''</font>
 
−
#Adjourned <hh:mm am/pm> <timezone>.
 
−
 
 
−
 
 
 
===Meeting Outcomes===
 
===Meeting Outcomes===
−
{|border="1" cellpadding="2" cellspacing="0"
+
{| {{table}}
 +
| align="center" style="background:#f0f0f0;"|'''Action Item'''
 +
| align="center" style="background:#f0f0f0;"|'''Owner'''
 +
| align="center" style="background:#f0f0f0;"|'''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
−
|                                                                |
 
−
|    AAAA    CCCCC  TTTTTT  IIIIII  OOOOO  NN    NN  SSSSS    |
 
−
|   AA  AA  CC        TT      II    OO  OO  NNN  NN  SS        |
 
−
|   AAAAAA  CC        TT      II    OO  OO  NN NN NN  SSSS      |
 
−
|   AA  AA  CC        TT      II    OO  OO  NN  NNN      SS    |
 
−
|  AA  AA  CCCCC    TT    IIIIII  OOOOO  NN    NN  SSSSS      |
 
−
|                                                                |
 
−
===============================================================--->
 
−
 
 
−
| width="100%" align="left" style="background:#f0f0f0;"|'''Actions''' ''<font color="green">(Include Owner, Action Item, and due date)''</font>
 
−
* .
 
 
|-
 
|-
−
<!---=======================================================================
+
|  
−
|                                                                         |
 
−
|  NN    NN  EEEEEE  XX  XX  TTTTTT      MM    MM  TTTTTT  GGGGG      |
 
−
|  NNN  NN  EE      XX XX    TT        MMM  MMM    TT    GG          |
 
−
|  NN NN NN  EEEE      XXX      TT        MM MMM MM    TT    GG  GGG    |
 
−
|  NN  NNN  EE      XX XX    TT        MM  M  MM    TT    GG  GG    |
 
−
|  NN    NN  EEEEEE  XX  XX    TT        MM    MM    TT    GGGGG      |
 
−
|                                                                          |
 
−
========================================================================--->
 
−
 
 
−
|width="100%" |'''Next Meeting/Preliminary Agenda Items'''<br/>
 
−
*.
 
 
|}
 
|}
 +
===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
  
 
© 2010 Health Level Seven® International.  All rights reserved.
 
© 2010 Health Level Seven® International.  All rights reserved.

Latest revision as of 20:19, 23 November 2010


Return to RCRIM Teleconference Minutes and Agendas

RCRIM Call Minutes

Meeting Information

HL7 RCRIM Meeting Minutes

Location: Location: Dial: 770-657-9270 Passcode: 745896#

Webex Info:

  1. Go to https://estripp.webex.com/estripp/j.php?ED=129183437&UID=0&PW=NNzQ1Nzg4NGZj&RT=MiM3
  2. If requested, enter your name and email address.
  3. 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

© 2010 Health Level Seven® International. All rights reserved.

Retrieved from "https://wiki.hl7.org/w/index.php?title=2010-11-23_RCRIM_Call_Minutes&oldid=43630"