Regulated Clinical Research Information Management (RCRIM) Technical Committee Meeting Minutes

January 15, 2007

Tuesday Q1 -SPL ballot reconciliation and Decision Making DocumentAttendees

First Name Last Name Affiliation E-mail AddressPaolo Alcim EMEA paolo.alcim@emea.europa.euLori Baranoski BMS lori.baranoski@bms.comBob Birmingham J&J rbirming@prdus.jnj.comTammy Feichtel Glemser Technologies tammy.feichtel@glemser.comWilliam Friggle Sanofi Aventis William.Friggle@sanofi-aventis.comJanet Gagnon Booz Allen Hamilton gagnon_janet@bah.comScott Getzin Eli Lilly and Company sgetzin@lilly.comLaura Gibson WK Health laura.gibson@wolterskluwer.comNorman Gregory FDA norman.gregory@fda.hhs.govTerry Hardin IBM thardin@us.ibm.comSmita Hastak Scenpro shastak@scenpro.comEd Helton CDISC / SAS Ed.Helton@sas.comJoyce Hernandez Merck joyce.hernandez@merck.comJulie Hurley RWD JHurley@rwd.comDon Kacher Oracle donald.kacher@oracle.comReina Kalish Baxter riena.kalish@baxter.comRebecca Kush CDISC rkush@cdisc.orgDoug Luczak Abbott Laboratories douglas.luczak@abbott.comAndrew Marr GSK Andrew.p.marr@gsk.comMukesh Mehta Thomson Mukesh.mehta@thomson.comJennifer Neat City of Hope jneat@coh.orgArmando Oliva FDA armando.oliva@fda.hhs.govCecile Pistre Sanofi Aventis cecile.pistre@sanofi-aventis.comPhil Pochon Covance Phil.Pochon@covance.comAndrea Poteat Baxter andrea.poteat@baxter.comJason Rock Global Submit jason.rock@globalsubmit.orgBill Rosen Pfizer william.rosen@pfizer.comSteve Sandberg Mayo ssandberg@mayo.eduGunther Schadow   gunther@aurora.regenstrief.orgKris Spahr Wyeth Pharmaceuticals spahrk@wyeth.comJohn Speakman NCI john.speakman@nih.hhs.gov Sadamu Takasaka HL7 Japan s-takasaka@m7.gyao.ne.jpJennifer Teta Merck jteta@merck.comEd Tripp Abbott Laboratories edward.tripp@abbott.comMarti Velezis Booz Allen Hamilton velezis_marti@bah.com

I. SPL ballot reconciliation

Below is a table with the results of the SPL R4 ballot.

  Aff. Neg. Abst. NVAffiliate 0 0 5 0Consultant 1 1 0 0General Int. 12 0 0 0Payor 0 0 0 0Pharmaceutical 21 0 1 0Provider 2 17 0 0Vendor 6 0 1 0Totals 42 18 7 0% of Votes 62.69% 26.87% 10.45% 0.00%

Quorum 100.00% Approval 40

The ballot passed approval and the consolidated comments are attached. Expectation is that as the week goes on all of the issues can be resolved with the comments from the other committees. Closure of the SPL ballot will be placed on the agenda for Q1 Thursday.There was a review of the UML model for SPL. Kris Sphar suggested that the SPL committee look at whether or not labeling and the product information be split and managed separately. The proposal is that the SPL technical team review and report back at the next Working Group Meeting.

II. Decision Making Document

Steve Ward, Tom Scarnecchia and Kris Spahr developed a revision to the RCRIM Decision Making Document. Kris presented and reviewed the attached document.Kris will revise the section 3. Notification of meetings and the intended agenda is provided prior to the meeting per discussion at the meeting and send the document out via the listserve. Additionally Kris will modify Quorum and Abstentions and DE-SD voting based on the discussion at the meeting.

Tuesday Q2 – BRIDG Update and EducationFirst Name Last Name Affiliation E-mail Address

Paolo Alcim EMEA paolo.alcim@emea.europa.euRobert Dunlop Infermed robert.dunlop@infermed.comJulie Evans CDISC jevans@cdisc.orgTammy Feichtel Glemser Technologies tammy.feichtel@glemser.comWilliam Friggle Sanofi Aventis William.Friggle@sanofi-aventis.comJanet Gagnon Booz Allen Hamilton gagnon_janet@bah.comScott Getzin Eli Lilly and Company sgetzin@lilly.comSmita Hastak Scenpro shastak@scenpro.comJoyce Hernandez Merck joyce.hernandez@merck.comJulie Hurley RWD JHurley@rwd.comDavid Iberson-Hurst CDISC dibersonhurst@cdisc.orgDon Kacher Oracle donald.kacher@oracle.comBron Kisler CDISC bkisler@cdisc.orgRebecca Kush CDISC rkush@cdisc.orgPierr-Yves Lastic Sanofi Aventis pierre-yves.lastic@sanofi-aventis.comDoug Luczak Abbott Laboratories douglas.luczak@abbott.comAndrew Marr GSK Andrew.p.marr@gsk.comMukesh Mehta Thomson Mukesh.mehta@thomson.comSaurin Mehta Novartis saurin.mehta@novartis.comMeredith Nahm Duke meredith.nahm@duke.eduArmando Oliva FDA armando.oliva@fda.hhs.govDianne Reeves NCTCB reevesd@mail.nih.govBill Rosen Pfizer william.rosen@pfizer.comSteve Sandberg Mayo ssandberg@mayo.eduKris Spahr Wyeth Pharmaceuticals spahrk@wyeth.comJohn Speakman NCI john.speakman@nih.hhs.gov Sadamu Takasaka HL7 Japan s-takasaka@m7.gyao.ne.jpJennifer Teta Merck jteta@merck.comSylvia Thun DIMDI sylvia.thun@dimdi.deEd Tripp Abbott Laboratories edward.tripp@abbott.comMarti Velezis Booz Allen Hamilton velezis_marti@bah.com

I. BRIDG Update and Education - Julie Evans and Bron KisslerJulie and Bron presented the attached slides.

Cara Willoughby is the current RCRIM representative on the BRIDG Advisory Board. Ed Helton will follow up with Cara on her ability to continue in this role given a recent change in job responsibilities.

Tuesday Q3 - CT lab message and CMET Abnormality Assessment ballot reconciliations and Clinical Decision Support updateAttendees

First Name Last Name Affiliation E-mail AddressPaolo Alcim EMEA paolo.alcim@emea.europa.eu

First Name Last Name Affiliation E-mail AddressLee Coller Oracle lee.coller@oracle.comWilliam Friggle Sanofi Aventis William.Friggle@sanofi-aventis.comJanet Gagnon Booz Allen Hamilton gagnon_janet@bah.comEd Helton CDISC / SAS Ed.Helton@sas.comJoyce Hernandez Merck joyce.hernandez@merck.comJulie Hurley RWD JHurley@rwd.comDon Kacher Oracle donald.kacher@oracle.comJohn Kilbourne NLM kilbourj@mail.nih.govBron Kisler CDISC bkisler@cdisc.orgGurnar Klein KI gurnar@kleink.seRebecca Kush CDISC rkush@cdisc.orgDoug Luczak Abbott Laboratories douglas.luczak@abbott.comBrian McCourt Duke brian.mccourt@duke.eduDoris McGinness SNOMED dmcginn@cap.orgBarbara McKinnon McKinnon Associates bmm15@comcast.netMukesh Mehta Thomson Mukesh.mehta@thomson.comMeredith Nahm Duke meredith.nahm@duke.eduJennifer Neat City of Hope jneat@coh.orgArmando Oliva FDA armando.oliva@fda.hhs.govPhil Pochon Covance Phil.Pochon@covance.comDianne Reeves NCTCB reevesd@mail.nih.govSteve Sandberg Mayo ssandberg@mayo.eduAbdul Malik Shakir Shakir Consulting shakirconsulting@cs.comKris Spahr Wyeth Pharmaceuticals spahrk@wyeth.comSadamu Takasaka HL7 Japan s-takasaka@m7.gyao.ne.jpJennifer Teta Merck jteta@merck.comSue Thompson NCPDP sthompson@ncpdp.orgEd Tripp Abbott Laboratories edward.tripp@abbott.comMarti Velezis Booz Allen Hamilton velezis_marti@bah.com

I. CT lab message and CMET Abnormality Assessment ballot reconciliations - Jennifer NeatThis is the summary of the ballot for the CT Lab Message Abnormality Assessment.

  Aff. Neg. Abst. NVAffiliate 0 0 5 0Consultant 1 0 0 0General Int. 1 0 0 0Payor 0 0 0 0Pharmaceutical 10 0 1 0Provider 19 0 1 0Vendor 7 0 0 0Totals 38 0 7 0

% of Votes 84.44% 0.00% 15.56% 0.00%

Quorum 100.00% Approval 26

On the CMET, there was a proposal to change Abnormality Assessment code from CD CNE to CD CWE. This was found to be persuasive and the proposal to change the code was accepted by the CT Lab Abnormality Assessment team.

Vote to accept the proposalAffirmative 11Opposed 0Abstain 13The change is accepted.The Suggestion on observation domains as an affirmative suggestion will be considered in the future development of the message. The SC data type was questioned the use of the data type vs CD CWE for ObservationValue for AssessmentException and GradeAnnotation. This was done this way to allow values that will not be coded in the future.The change from a CD SC to CWE is a substantive change. The TSC can decide if it is re balloted. Abdul-Malik will bring this to John Quinn for determination if another ballot is necessary.Abdul-Malik made a motion that RCRIM propose to the TSC that the minor substantive change does not have great impact on implementers and therefore would like to have the TSC waive the need to re-ballot.

Vote:Affirmative 13Opposed 0Abstain 10Motion carriesNCI Thesaurus has Abnormality Assessment vocabulary. The Vocabulary list will be named RCRIM Abnormality Assessment.Next steps will be to work on an implementation guide for the CT Lab Message Abnormality Assessment and an Implementation Guide for the CMET.The team is looking for organizations to be identified and participate in DSTU use. The team will describe the type of organization they are looking for but generally a group that has a need for automated clinical laboratory data, especially those that currently use the CT Lab message.

II. Clinical Decision Support update on GELLO and the Virtual Medical Record (vMR) - Barbara McKinnonRobert Dunlop (sponsor of the vMR GELLO project) provided the following.

Tuesday Q4 – Vocabulary - Bron KisslerFirst Name Last Name Affiliation E-mail Address

Paolo Alcim EMEA paolo.alcim@emea.europa.euJulie Evans CDISC jevans@cdisc.orgJanet Gagnon Booz Allen Hamilton gagnon_janet@bah.comScott Getzin Eli Lilly and Company sgetzin@lilly.comNorman Gregory FDA norman.gregory@fda.hhs.govJoyce Hernandez Merck joyce.hernandez@merck.comEmily Honeycutt Duke emily.honeycutt@duke.eduDavid Iberson-Hurst CDISC dibersonhurst@cdisc.orgDon Kacher Oracle donald.kacher@oracle.comBron Kisler CDISC bkisler@cdisc.orgTed Klein KCI ted@tklein.comDoug Luczak Abbott Laboratories douglas.luczak@abbott.comAndrew Marr GSK Andrew.p.marr@gsk.comBrian McCourt Duke brian.mccourt@duke.eduMukesh Mehta Thomson Mukesh.mehta@thomson.comSaurin Mehta Novartis saurin.mehta@novartis.comMeredith Nahm Duke meredith.nahm@duke.edu

First Name Last Name Affiliation E-mail AddressJennifer Neat City of Hope jneat@coh.orgDale Nelson   dale@zed-logic.comPhil Pochon Covance Phil.Pochon@covance.comDianne Reeves NCTCB reevesd@mail.nih.govJason Rock Global Submit jason.rock@globalsubmit.orgBill Rosen Pfizer william.rosen@pfizer.comSteve Sandberg Mayo ssandberg@mayo.eduKris Spahr Wyeth Pharmaceuticals spahrk@wyeth.comSadamu Takasaka HL7 Japan s-takasaka@m7.gyao.ne.jpJennifer Teta Merck jteta@merck.comEd Tripp Abbott Laboratories edward.tripp@abbott.comMarti Velezis Booz Allen Hamilton velezis_marti@bah.comAnita Walden Duke anita.walden@duke.edu

I. Terminology Update – Bron KislerBron presented the following in the attached presentationa) SDTM Terminology Project Update including labtestb) Terminology Harmonization Activities (CDASH, SEND)c) 2008 Terminology priorities (CDISC, RCRIM)d) Changes with NCI EVS Organization

II. RCRIM-CHI Terminology Mapping (Ted Klein – 20 minutes)There were three V2.5 terminologies that impact RCRIM.

Manufactures of Vaccines Vaccines Administered Controlled Substance Schedule.

Suggested mappings are:Manufactures of Vaccines – No table: out of Chi domainVaccines Administered – Medication Drug ProductControlled Substance Schedule – SPLRCRIM will follow up after further discussion to confirm the mapping.

III. TB & Cardiology Data Standards Projects (Duke Team – 20 minutes)The Duke Team presented the following:

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