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

September 17, 2008

Wednesday Q1 – BRIDG, Protocol and Clinical RegistrationAttendeesFirst Name Last Name Affiliation E-mail Address

Lisa Chatterjee Digital Infuzion lisac@digitalinfuzion.comSue Dubman Genzyme sue.dubman@genzyme.comKristi Eckerson Emory University keckers@emory.eduJulie Evans CDISC jevans@cdisc.orgDavera Gabriel University of California, Davis davera@ucdavis.eduSmita Hastak Scenpro shastak@scenpro.comEd Helton NCI edward.helton@nih.govJoyce Hernandez Merck joyce.hernandez@merck.comDavid Iberson-Hurst CDISC dibersonhurst@cdisc.orgRaffael Jovine Int.Inst. For SAEE of Meds. raffael.jovine@ii4sm.comBron Kisler CDISC bkisler@cdisc.orgWayne Kubick Lincoln Technologies (CDISC)wayne.kubick@lincolntechnologies.comPierre-Yves Lastic Sanofi Aventis pierre-yves.lastic@sanofi-aventis.comMary Lenzen Octagon mlenzen@octagonresearch.comCharlie Mead NCI charlie.mead@booz.comTim Morris Emory University timothy.morris@emory.eduBarrie Nelson Amgen barrien@amgen.comArmando Oliva FDA armando.oliva@fda.hhs.govCecile Pistre Sanofi Aventis cecile.pistre@sanofi-aventis.comMitra Rocca Novartis mitra.rocca@novartis.comSteve Sandberg Mayo Clinic/Foundation ssandberg@mayo.eduBenjamin Schoenbrun Booze Allen Hamilton schoenbrun.benjamin@bah.comKris Spahr Wyeth Pharmaceuticals spahrk@wyeth.comJohn Speakman NCI john.speakman@nih.gov Anita Walden Duke anita.walden@duke.eduSteve Ward Lilly stw@lilly.comDiane Wold GSK diane.e.wold@gsk.com

I. Protocol Representation Standards V 1.0 - Lisa ChatterjeeLisa gave background and update – CDISC elements spreadsheet was original basis of BRIDG. PR and the other CDISC standards will continue to exist independent of BRIDG

Q: RCRIM has voted to use BRIDG as the DAM. How do we implement this?

A: Through using it in message ballots – reviewing the appropriate portions of BRIDG in each message.

Q: Should we ballot on BRIDG as an informative document?A: There is an ideal time for this: discuss after Charlie’s presentation.

II. Status of Domain Model (BRIDG Update and issues) - Julie Evans, Charlie MeadBRIDG update – Julie Evans

BRIDG lessons learned and next steps – Charlie Mead

Next step #1: Two-layer model, one of which is a series of subdomains represented in a domain-expert-friendly way, and the other is a RIM-mappable model that can be used by developers.Next step #2: OWL representation currently underway

Draft for both will be in October. Once these are out, this may be a good time to bring BRIDG for ballot at RCRIM as an informative document.

Provocative proposal: is the “lower level” of the two-level model effectively the RCRIM DMIM? Extensive discussion.

Wednesday Q2 – EHR and Clinical Trials RegistryAttendeesFirst Name Last Name Affiliation E-mail Address

Glen Austin Health Canada glenn.austin@hc-sc.gc.caLouis Boulay Health Canada Louis.boulay@nc-sc.gc.caLisa Chatterjee Digital Infuzion lisac@digitalinfuzion.comSue Dubman Genzyme sue.dubman@genzyme.comKristi Eckerson Emory University keckers@emory.eduJulie Evans CDISC jevans@cdisc.orgDavera Gabriel University of California, Davis davera@ucdavis.eduNorman Gregory FDA norman.gregory@fda.hhs.govEd Helton NCI edward.helton@nih.govDavid Iberson-Hurst CDISC dibersonhurst@cdisc.orgRaffael Jovine Int.Inst. For SAEE of Meds. raffael.jovine@ii4sm.comBron Kisler CDISC bkisler@cdisc.orgWayne Kubick Lincoln Technologies (CDISC)wayne.kubick@lincolntechnologies.com

First Name Last Name Affiliation E-mail AddressPierre-Yves Lastic Sanofi Aventis pierre-yves.lastic@sanofi-aventis.comArmando Oliva FDA armando.oliva@fda.hhs.govCecile Pistre Sanofi Aventis cecile.pistre@sanofi-aventis.comMitra Rocca Novartis mitra.rocca@novartis.comKris Spahr Wyeth Pharmaceuticals spahrk@wyeth.comJohn Speakman NCI john.speakman@nih.gov Ed Tripp Abbott Laboratories edward.tripp@abbott.comGeraldine Wade Hewlett-Packard geraldine.wade@hp.comAnita Walden Duke anita.walden@duke.eduSteve Ward Lilly stw@lilly.comDiane Wold GSK diane.e.wold@gsk.com

I. Clinical Trial Registry Project – Kris SpahrReviewed presentation (attached) and scoping statement. Will start with BRIDG. Discussion re kinds of outreach the project needs to adopt towards becoming ISO standard – project should probably explicitly figure this out. The team is seeking approval of scoping statement with a view to DSTU in April. The distinction between the trial registry content of this project and that in the CDISC PR is that this project is making a version 3 message (maybe two messages in fact). Some changes to wording of scoping statement suggested - revised draft would be circulated tomorrow (hopefully Q1).

Scope statement reviewed

II. EHR CR Functional Profile Ballot - Mitra RoccaObjective: create a Clinical Research Functional Profile based on criteria from EuroRec. Plan is for it to be published today as Informative Standard and then resubmitted for Normative Standard after CDISC CDASH R1 is finalized. There will need to be a quarter set aside for ballot reconciliation in January. There needs to be work to map CDASH to BRIDG (this work being done by CDISC – will be done by March).

Wednesday Q3 – Business meetingFirst Name Last Name Affiliation E-mail Address

Glen Austin Health Canada glenn.austin@hc-sc.gc.caLouis Boulay Health Canada Louis.boulay@nc-sc.gc.caTim Buxton EMEA tim.buxton@emea.europa.euLisa Chatterjee Digital Infuzion lisac@digitalinfuzion.comJulie Evans CDISC jevans@cdisc.orgPatricia Garvey FDA patricia.garvey@fda.hhs.govNorman Gregory FDA norman.gregory@fda.hhs.govSmita Hastak Scenpro shastak@scenpro.comEd Helton NCI edward.helton@nih.govDavid Iberson-Hurst CDISC dibersonhurst@cdisc.orgRaffael Jovine Int.Inst. For SAEE of Meds. raffael.jovine@ii4sm.comBron Kisler CDISC bkisler@cdisc.orgDiasuke Koide University of Tokyo koide-tky@umin.go.jpPeggy Leizear FDA peggy.leizear@fda.hhs.govAndrew Marr GSK Andrew.p.marr@gsk.comArmando Oliva FDA armando.oliva@fda.hhs.govCecile Pistre Sanofi Aventis cecile.pistre@sanofi-aventis.comBill Rosen Pfizer william.rosen@pfizer.comSteve Sandberg Mayo Clinic/Foundation ssandberg@mayo.eduKris Spahr Wyeth Pharmaceuticals spahrk@wyeth.comJohn Speakman NCI john.speakman@nih.gov Ed Tripp Abbott Laboratories edward.tripp@abbott.comSteve Ward Lilly stw@lilly.comTaku Watanbe PMDA watanabe-taku@pmda.go.jpDiane Wold GSK diane.e.wold@gsk.com

I. Approval of May WG Minutes – Co-chairsNorman Gregory made a motion to approve the minutes from the May Working Group Meeting. Julie Evans seconded the motion. Affirmative: 23Negative 0Abstain 1Motion Passes

II. Project updates – Project Leads

a) CDISC Content to MessageThe two messages went to ballot. Ballot reconciliation will be done in Q3 Thursday. The requirements group is developing use cases and storyboards for Study Data. The team spent four quarters on harmonization to the BRIDG on Tuesday.

b) Drug Stability Reporting (eStability)Version 2 of the standard and the Implementation Guide passed the ballot. Both will be re-balloted in January to address changes to the standard that were made through ballot reconciliation.

c) HL7 Specifications for Exchanging Clinical Laboratory Data from Clinical Research

Per e-mail from Phil Pochon, CTLAB is the old, now normative release 1 and should be closed.

d) Laboratory Test Result Abnormality AssessmentNo Update.

e) Medical Product and Device ListingOn hold pending Common Product Model

f) Periodic Reporting of Clinical Trial Laboratory Data, Release 2Per e-mail from Phil Pochon CTLAB 2 is the Pharmacogenomics work. It is still open, but we are using the Clinical Genomics work group

g) Regulated Product Submission Release 2Six quarters of working sessions were held with up to 40 people participating on review and detail of use scenarios. Requirements for iteration are scheduled to be complete in October. January 2010.

h) SPL IG for FDA Content of LabelingSPL IG for r4 will be balloted in January

i) Structured Product Labeling (SPL) - Release 4Passed ballot with no comments.

j) Clinical Research Filtered Query Service Functional Model (not listed on Project page for RCRIM)

Looking for participants to implement the DSTU.

k) Individual Case Safety Report (ICSR) Release 2 (not listed on Project page for RCRIM)

This project is a part of the JIC and there are currently some modeling issues that need to be resolved related to the product model. This will be balloted in January.

III. Teleconference Scheduling – Co-chairs1

a) Monday

Drug Stability Reporting (eStability)Current: 10:00 a.m. – 11:00 a.m. Weekly (next call September 22, 2008)New: Same as current

SPL Technical Team CallCurrent: 2:00 p.m. – 3:00 p.m. Biweekly (next call September 29, 2008)New: Same as current.

1 All times listed are US Eastern Time, GMT -4 DST

b) Tuesday

RCRIM Work GroupCurrent: 10:00 a.m. – 11:00 a.m. Biweekly (next call September 30, 2008)New: Same as current.

Laboratory Result Based Adverse Event Assessment ProjectCurrent: 10:00 a.m. – 11:00 a.m. Biweekly (next call September 23, 2008)New: Thursday 1:00 p.m. – 2:00 p.m. Biweekly (next call October 9, 2008)

RCRIM RPS r2 Biweekly callCurrent: Rotating Biweekly (next call September 23, 2008)

7:00 a.m. – 8:30 a.m.Noon – 1:30 p.m.8:00 p.m. – 9:30 p.m.

New: Same as current. There will also be an additional call on requirements to be scheduled weekly.

c) Wednesday

CDISC Content to HL7 Message Stage 2Current: 11:00 a.m. – 1:00 p.m. Biweekly (next call October 1, 2008)New: Same as current.

d) Thursday

CDISC to HL7 Stage ICurrent: 11:00 a.m. – Noon Biweekly (next call September 25, 2008)New:. Same as current.

RCRIM VocabularyCurrent: 11:00 a.m. – Noon Biweekly (next call September 25, 2008)New: Same time current but next call October 2, 2008.

e) Friday

RCRIM joint meeting with Clinical GenomicsCurrent: 10:00 a.m. – Noon Biweekly (next call October 3, 2008)New: Same as current.

f) Projects without calls scheduled

HL7 Specifications for Exchanging Clinical Laboratory Data from Clinical Research

To be closed.

Medical Product and Device ListingOn Hold

Periodic Reporting of Clinical Trial Laboratory Data, Release 2Per email from Phil Pochon, CTLAB 2 is using the Clinical Genomics work group and telecon number for these meetings See Joint call with Clinical Genomics

SPL IG for FDA Content of LabelingManaged in the SPL technical call.

Structured Product Labeling (SPL) - Release 4Project complete

Clinical Trial Registration and ResultsNo teleconference at this time. Request will be made at a biweekly RCRIM teleconference.

IV. Update on Identification of medicinal products ISO, CEN HL7 – Tim BuxtonThere are five work items including ID of medicinal products, and ID of pharmaceutical products. Comments suggested that the scope should be revised. They were widened and a set of documents for ballot will be put forward through working group 6. The modeling is being done in a common methodology on all five work items. There are five documents, the model and a document on maintenance.

V. Publishing Calendar

The group reviewed of the publishing schedule.

VI. Workgroup Scorecard

The group reviewed the DESD Scorecard for Workgroups.

Wednesday Q4 – Patient Safety and VocabularyFirst Name Last Name Affiliation E-mail Address

Ayumi Endo PMDA endo-ayumi@pmda.go.jpJulie Evans CDISC jevans@cdisc.orgPatricia Garvey FDA patricia.garvey@fda.hhs.govNorman Gregory FDA norman.gregory@fda.hhs.govNicholas Halsey European Medicines Agency Nick.Halsey@emea.europa.euSmita Hastak Scenpro shastak@scenpro.comEd Helton NCI edward.helton@nih.govDavid Iberson-Hurst CDISC dibersonhurst@cdisc.orgRaffael Jovine Int.Inst. For SAEE of Meds. raffael.jovine@ii4sm.comDiasuke Koide University of Tokyo koide-tky@umin.go.jpAndrew Marr GSK Andrew.p.marr@gsk.comCecile Pistre Sanofi Aventis cecile.pistre@sanofi-aventis.comBill Rosen Pfizer william.rosen@pfizer.comSteve Sandberg Mayo Clinic/Foundation ssandberg@mayo.eduKris Spahr Wyeth Pharmaceuticals spahrk@wyeth.comJohn Speakman NCI john.speakman@nih.gov Lise Stevens FDA lise.stevens@fda.hhs.govEd Tripp Abbott Laboratories edward.tripp@abbott.comSteve Ward Lilly stw@lilly.comTaku Watanbe PMDA watanabe-taku@pmda.go.jp

I. Vocabulary Update - Bron Kisler

Bron presented the material above and walked the group through the CDISC terminology website. Bron presented a walkthrough of the CDSIC terminology spreadsheets that are available on the CDISC website or the NCI EVS site. Attached are two examples.

II. Update From Patient Safety Work Group – Lise StevensLise presented the attached material.

III. Common Product Model – Ed TrippEd presented the concept of a common product model with the following illustrative diagram, explaining that each of the standards illustrated need product information. SPL needs general product information about active and inactive ingredients. ICSR needs similar information but needs to extend the information to instance specific information such as lot specific or item specific identification. Stability needs active ingredient information and some specific lot information. A common model on how to describe products can be used by these standards as well as other RCRIM, Patient Safety, Pharmacy and Orders and Observation standards by utilizing relevant sections of the model. Discussions will continue Q2 Thursday.

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