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HL7 RCRIM Working Group Meeting MinutesOctober 6, 2010
Wednesday Q1 AttendeesFirst Name Last Name Affiliation E-mail AddressMichael Brennan Johnson &Johnson mbrenna&its.jnj.comPam Cafieco Boehringer Ingelheim
Christel Daniel [email protected] Dezegher PAREXEL [email protected] Farr FDA shahla.farr&fda.hhs.govWilliam Friggle Sanofi Aventis [email protected] Getzin Eli Lilly and Company [email protected] Kiser Abbott Laboratories [email protected] Koide University of Tokyo [email protected] Lastic Sanofi Aventis pierre-yves.lastic@sanofi-
aventis.comJay Levine FDA [email protected] Richardson Univ of South Florida [email protected] Rock Global Submit [email protected] Tripp Edward S. Tripp and
Steve Ward Lilly [email protected] Zhang Genzyme [email protected]
I. RPS Project update Jason RockJason presented the attached slides.
The DSTU Publication request was sent to the Technical Steering Committee for approval.
Wednesday Q2 AttendeesFirst Name Last Name Affiliation E-mail AddressMichael Brennan Johnson & Johnson [email protected] Davias Sanofi Aventis [email protected] Farr FDA shahla.farr.fda.hhs.govWilliam Friggle Sanofi Aventis [email protected] Getzin Eli Lilly and Company [email protected] Gregory FDA [email protected] Hardin Parexel [email protected]
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HL7 RCRIM Working Group Meeting MinutesOctober 6, 2010
First Name Last Name Affiliation E-mail AddressEd Helton NCI [email protected] Iberson-
HurstCDISC [email protected]
John Kiser Abbott Laboratories [email protected] Kisler CDISC [email protected] Lastic Sanofi Aventis pierre-yves.lastic@sanofi-
aventis.comLatousha Leslie FDA [email protected] Levine FDA [email protected] Reed FDA [email protected] Rock Global Submit [email protected] Tripp Edward S. Tripp and
Steve Ward Lilly [email protected] Zhang Genzyme [email protected]
I. Sydney WGMThe results of the doodle poll indicated that of the 35 poll participants only 6 plus a co-chair were planning on attending with 9 maybe attending responses. Since the poll, one participant changed from maybe to will attend but this still is short of the 10 plus a co-chair needed for quorum. A review of the projects indicated that none of the current active projects were planning work sessions at the working group meeting and that the only ballot item that is scheduled for January is the Study Design Implementation Guide.There was a great deal of discussion around the desire to make the Working Group Meeting more of a working session. It was noted that this is in part the responsibility of the project teams. Several project teams indicated that they did not want working sessions in Cambridge and one team did not desire to give an update, although they agreed after some discussion. It was the general consensus of the group that there was insufficient work to plan for a Sydney meeting, however, RCRIM should make every effort to build a full agenda for the May 2011 meeting in Orlando, including working sessions for the project teams.Following the discussion, Terry Harding sent an e-mail suggesting the following as topics for May
1. CDA and how the clinical statement fits with the CDISC messages.2. BRIDG 3.0.2 - OWL, semantics, etc.3. RPS4. Common Product Model and how it fits with RCRIM messages
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HL7 RCRIM Working Group Meeting MinutesOctober 6, 2010
II. Patient Care Project Scope Statement
Patient Care has asked for Domain Expert Steering Division Approval of the above project scope statement. RCRIM reviewed the statement and has no issues with it. Ed Tripp will cast a vote to approve the Project Scope Statement.
III. Teleconference ScheduleBelow is the updated teleconference schedule for calls not schedule or confirmed Q3 Tuesday:
Project Call Name Period Day Time DurationClinical Trials Registration and Results
CTR&R Biweekly Wednesday 11:00 1 hr
Laboratory Result-based AE Assessment
Lab AE As needed
SPLr5 SPLr5 Biweekly Thursday 10:30 1 hrPeriodic Reporting of Clinical Trial Laboratory Data, Release 2
CTLab2 None
RPS RPS Leadership Call
Biweekly Tuesday 7:30 1 hr
RCRIM Vocabulary RCRIM Vocabulary
Biweekly Thursday 11:00 1.5 hour
IV. Update 3 Yr Plan
Attached is the current three year planThe three year plan was amended and will be reviewed on a future teleconference. The attached update represents the summary of the discussion and a few additions based on e-mails received following the meeting.
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HL7 RCRIM Working Group Meeting MinutesOctober 6, 2010
V. Decision Making Practices
This is the new template
This is a comparison of new items in the template vs current RCRIM DMP.
This is the current RCRIM DMP documentThe following details will be removed from the RCRIM DMP
Minutes, agendas, and action items will be posted under the “Minutes” section of the RCRIM committee website. The naming convention is: CCYY-MM-DD RCRIM <Venue, e.g. WG or Call (Agenda, Minutes, etc.)> <City (for WG)>, for example, "2004-01-22 PIC WG Agenda San Diego" or "2004-01-05 PIC Call Minutes".
The specifics on advanced distribution of material prior to conducting a vote under item 3. “Notification of meetings and the intended agenda is provided prior to the meeting” Should be added to the template. An update of the DMP will be made and circulated to the RCRIM Listserve for review.
Wednesday Q3First Name Last Name Affiliation E-mail AddressIsabelle Davias Sanofi Aventis [email protected] Dezegher PAREXEL [email protected] Dunlop Infermed [email protected] Farr FDA [email protected] Friggle Sanofi Aventis [email protected] Getzin Eli Lilly and Company [email protected] Hardin Parexel [email protected] Helton NCI [email protected] Hernandez Merck [email protected] Iberson-Hurst CDISC [email protected] Kiser Abbott Laboratories [email protected] Kubick Lincoln Technologies
(CDISC)[email protected]
Pierre-Yves Lastic Sanofi Aventis [email protected] Levine FDA [email protected] Oliva FDA [email protected] Rocca FDA [email protected]
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HL7 RCRIM Working Group Meeting MinutesOctober 6, 2010
First Name Last Name Affiliation E-mail AddressJason Rock Global Submit [email protected] Schadow Regenstrief Institute,
Sadamu Takasaka HL7 Japan [email protected] Tripp Edward S. Tripp and
Steve Ward Lilly [email protected] Zhang Genzyme [email protected]
I. Study Participation IG ballot reconciliation Mitra Rocca and Joyce HernandezBelow is the summary of the balloting
Aff. Neg. Abst. NVAffiliate 0 0 24 1Consultant 0 1 6 0General Int. 1 0 1 1Payor 4 0 0 1Pharmaceutical 33 10 0 2Provider 14 0 15 2Vendor 4 0 19 4Totals 56 11 65 11% of Votes 39.16% 7.69% 45.45% 7.69%Quorum 92.31%Approval 41
Mitra presented an overview of Study Participation
The following ballot reconciliation spreadsheet was discussed and modified as shown below.
A motion was made by Jason Rock and seconded by Joyce Hernandez to approve the ballot reconciliation.Affirmative: 20Opposed: 0Abstain: 1
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Motion Carries
Wednesday Q4First Name Last Name Affiliation E-mail AddressTim Buxton EMA [email protected] Davias Sanofi Aventis [email protected] Dedels VIRTIFY [email protected] Farr FDA [email protected] Friggle Sanofi Aventis [email protected] Getzin Eli Lilly and Company [email protected] Hardin Parexel [email protected] Helton NCI [email protected] Iberson-Hurst CDISC [email protected] Kiser Abbott Laboratories [email protected] Kisler CDISC [email protected] Koide University of Tokyo [email protected] Kubick Lincoln Technologies
(CDISC)[email protected]
Pierre-Yves Lastic Sanofi Aventis [email protected] Oliva FDA [email protected] Richardson University of South
Ed Tripp Edward S. Tripp and Associates
Anmol Wassan VIrRTFY [email protected] Zhang Genzyme [email protected]
I. CTR&R Abdul Malik Shakir
AMS presented the slides summarizing the ballot reconciliation of the CTR&R DAM Ballot and the CTR&R Message. The ballot reconciliation packages are included below.
Motion was made by Terry Hardin, seconded by Abdul Malik Shakir to approve the ballot reconciliation package for the DAM.Affirmative: 16Opposed: 0Abstain: 2
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HL7 RCRIM Working Group Meeting MinutesOctober 6, 2010
Motion CarriesAMS reviewed the comments on the CTR&R Message
Motion was made by Terry Hardin, seconded by John Speakman to approve the ballot reconciliation package for the message.Affirmative: 17Opposed: 0Abstain: 1Motion CarriesThe ballot reconciliation will be uploaded to the ballot site, and a request to withdraw negatives will be generated. The DSTU publication request form will be processed in October.Scot Getzin presented the CTR&R next steps.
Ed Tripp will post the reconciliation packages, prepare the request for DSTU publication and send it to the TSC when the DSTU materials have been uploaded to Don Lloyd.
II. BRIDG Bron Kisler
Bron presented the update on BRIDG.End of Document
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