Control/Query Meeting Minutes (Heading 1)



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

September 17, 2008

Wednesday Q1 – BRIDG, Protocol and Clinical Registration

Attendees

|First Name |Last Name |Affiliation |E-mail Address |

|Lisa |Chatterjee |Digital Infuzion |lisac@ |

|Sue |Dubman |Genzyme |sue.dubman@ |

|Kristi |Eckerson |Emory University |keckers@emory.edu |

|Julie |Evans |CDISC |jevans@ |

|Davera |Gabriel |University of California, Davis |davera@ucdavis.edu |

|Smita |Hastak |Scenpro |shastak@ |

|Ed |Helton |NCI |edward.helton@ |

|Joyce |Hernandez |Merck |joyce.hernandez@ |

|David |Iberson-Hurst |CDISC |dibersonhurst@ |

|Raffael |Jovine |Int.Inst. For SAEE of Meds. |raffael.jovine@ |

|Bron |Kisler |CDISC |bkisler@ |

|Wayne |Kubick |Lincoln Technologies (CDISC) |wayne.kubick@ |

|Pierre-Yves |Lastic |Sanofi Aventis |pierre-yves.lastic@sanofi- |

|Mary |Lenzen |Octagon |mlenzen@ |

|Charlie |Mead |NCI |charlie.mead@ |

|Tim |Morris |Emory University |timothy.morris@emory.edu |

|Barrie |Nelson |Amgen |barrien@ |

|Armando |Oliva |FDA |armando.oliva@fda. |

|Cecile |Pistre |Sanofi Aventis |cecile.pistre@sanofi- |

|Mitra |Rocca |Novartis |mitra.rocca@ |

|Steve |Sandberg |Mayo Clinic/Foundation |ssandberg@mayo.edu |

|Benjamin |Schoenbrun |Booze Allen Hamilton |schoenbrun.benjamin@ |

|Kris |Spahr |Wyeth Pharmaceuticals |spahrk@ |

|John |Speakman |NCI |john.speakman@ |

|Anita |Walden |Duke |anita.walden@duke.edu |

|Steve |Ward |Lilly |stw@ |

|Diane |Wold |GSK |diane.e.wold@ |

I. Protocol Representation Standards V 1.0 - Lisa Chatterjee

Lisa 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

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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 Mead

BRIDG update – Julie Evans

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BRIDG lessons learned and next steps – Charlie Mead

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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 Registry

Attendees

|First Name |Last Name |Affiliation |E-mail Address |

|Glen |Austin |Health Canada |glenn.austin@hc-sc.gc.ca |

|Louis |Boulay |Health Canada |Louis.boulay@nc-sc.gc.ca |

|Lisa |Chatterjee |Digital Infuzion |lisac@ |

|Sue |Dubman |Genzyme |sue.dubman@ |

|Kristi |Eckerson |Emory University |keckers@emory.edu |

|Julie |Evans |CDISC |jevans@ |

|Davera |Gabriel |University of California, Davis |davera@ucdavis.edu |

|Norman |Gregory |FDA |norman.gregory@fda. |

|Ed |Helton |NCI |edward.helton@ |

|David |Iberson-Hurst |CDISC |dibersonhurst@ |

|Raffael |Jovine |Int.Inst. For SAEE of Meds. |raffael.jovine@ |

|Bron |Kisler |CDISC |bkisler@ |

|Wayne |Kubick |Lincoln Technologies (CDISC) |wayne.kubick@ |

|Pierre-Yves |Lastic |Sanofi Aventis |pierre-yves.lastic@sanofi- |

|Armando |Oliva |FDA |armando.oliva@fda. |

|Cecile |Pistre |Sanofi Aventis |cecile.pistre@sanofi- |

|Mitra |Rocca |Novartis |mitra.rocca@ |

|Kris |Spahr |Wyeth Pharmaceuticals |spahrk@ |

|John |Speakman |NCI |john.speakman@ |

|Ed |Tripp |Abbott Laboratories |edward.tripp@ |

|Geraldine |Wade |Hewlett-Packard |geraldine.wade@ |

|Anita |Walden |Duke |anita.walden@duke.edu |

|Steve |Ward |Lilly |stw@ |

|Diane |Wold |GSK |diane.e.wold@ |

I. Clinical Trial Registry Project – Kris Spahr

Reviewed 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).

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Scope statement reviewed

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II. EHR CR Functional Profile Ballot - Mitra Rocca

Objective: 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).

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Wednesday Q3 – Business meeting

|First Name |Last Name |Affiliation |E-mail Address |

|Glen |Austin |Health Canada |glenn.austin@hc-sc.gc.ca |

|Louis |Boulay |Health Canada |Louis.boulay@nc-sc.gc.ca |

|Tim |Buxton |EMEA |tim.buxton@emea.europa.eu |

|Lisa |Chatterjee |Digital Infuzion |lisac@ |

|Julie |Evans |CDISC |jevans@ |

|Patricia |Garvey |FDA |patricia.garvey@fda. |

|Norman |Gregory |FDA |norman.gregory@fda. |

|Smita |Hastak |Scenpro |shastak@ |

|Ed |Helton |NCI |edward.helton@ |

|David |Iberson-Hurst |CDISC |dibersonhurst@ |

|Raffael |Jovine |Int.Inst. For SAEE of Meds. |raffael.jovine@ |

|Bron |Kisler |CDISC |bkisler@ |

|Diasuke |Koide |University of Tokyo |koide-tky@umin.go.jp |

|Peggy |Leizear |FDA |peggy.leizear@fda. |

|Andrew |Marr |GSK |Andrew.p.marr@ |

|Armando |Oliva |FDA |armando.oliva@fda. |

|Cecile |Pistre |Sanofi Aventis |cecile.pistre@sanofi- |

|Bill |Rosen |Pfizer |william.rosen@ |

|Steve |Sandberg |Mayo Clinic/Foundation |ssandberg@mayo.edu |

|Kris |Spahr |Wyeth Pharmaceuticals |spahrk@ |

|John |Speakman |NCI |john.speakman@ |

|Ed |Tripp |Abbott Laboratories |edward.tripp@ |

|Steve |Ward |Lilly |stw@ |

|Taku |Watanbe |PMDA |watanabe-taku@pmda.go.jp |

|Diane |Wold |GSK |diane.e.wold@ |

I. Approval of May WG Minutes – Co-chairs

Norman Gregory made a motion to approve the minutes from the May Working Group Meeting. Julie Evans seconded the motion.

Affirmative: 23

Negative 0

Abstain 1

Motion Passes

II. Project updates – Project Leads

a) CDISC Content to Message

The 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 Assessment

No Update.

e) Medical Product and Device Listing

On hold pending Common Product Model

f) Periodic Reporting of Clinical Trial Laboratory Data, Release 2

Per 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 2

Six 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 Labeling

SPL IG for r4 will be balloted in January

i) Structured Product Labeling (SPL) - Release 4

Passed 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-chairs[1]

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 Call

Current: 2:00 p.m. – 3:00 p.m. Biweekly (next call September 29, 2008)

New: Same as current.

l) Tuesday

• RCRIM Work Group

Current: 10:00 a.m. – 11:00 a.m. Biweekly (next call September 30, 2008)

New: Same as current.

• Laboratory Result Based Adverse Event Assessment Project

Current: 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 call

Current: 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.

m) Wednesday

• CDISC Content to HL7 Message Stage 2

Current: 11:00 a.m. – 1:00 p.m. Biweekly (next call October 1, 2008)

New: Same as current.

n) Thursday

• CDISC to HL7 Stage I

Current: 11:00 a.m. – Noon Biweekly (next call September 25, 2008)

New:. Same as current.

• RCRIM Vocabulary

Current: 11:00 a.m. – Noon Biweekly (next call September 25, 2008)

New: Same time current but next call October 2, 2008.

o) Friday

• RCRIM joint meeting with Clinical Genomics

Current: 10:00 a.m. – Noon Biweekly (next call October 3, 2008)

New: Same as current.

p) Projects without calls scheduled

• HL7 Specifications for Exchanging Clinical Laboratory Data from Clinical Research

To be closed.

• Medical Product and Device Listing

On Hold

• Periodic Reporting of Clinical Trial Laboratory Data, Release 2

Per 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 Labeling

Managed in the SPL technical call.

• Structured Product Labeling (SPL) - Release 4

Project complete

• Clinical Trial Registration and Results

No teleconference at this time. Request will be made at a biweekly RCRIM teleconference.

IV. Update on Identification of medicinal products ISO, CEN HL7 – Tim Buxton

There 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.

III. Publishing Calendar

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The group reviewed of the publishing schedule.

IV. Workgroup Scorecard

The group reviewed the DESD Scorecard for Workgroups.

Wednesday Q4 – Patient Safety and Vocabulary

|First Name |Last Name |Affiliation |E-mail Address |

|Ayumi |Endo |PMDA |endo-ayumi@pmda.go.jp |

|Julie |Evans |CDISC |jevans@ |

|Patricia |Garvey |FDA |patricia.garvey@fda. |

|Norman |Gregory |FDA |norman.gregory@fda. |

|Nicholas |Halsey |European Medicines Agency |Nick.Halsey@emea.europa.eu |

|Smita |Hastak |Scenpro |shastak@ |

|Ed |Helton |NCI |edward.helton@ |

|David |Iberson-Hurst |CDISC |dibersonhurst@ |

|Raffael |Jovine |Int.Inst. For SAEE of Meds. |raffael.jovine@ |

|Diasuke |Koide |University of Tokyo |koide-tky@umin.go.jp |

|Andrew |Marr |GSK |Andrew.p.marr@ |

|Cecile |Pistre |Sanofi Aventis |cecile.pistre@sanofi- |

|Bill |Rosen |Pfizer |william.rosen@ |

|Steve |Sandberg |Mayo Clinic/Foundation |ssandberg@mayo.edu |

|Kris |Spahr |Wyeth Pharmaceuticals |spahrk@ |

|John |Speakman |NCI |john.speakman@ |

|Lise |Stevens |FDA |lise.stevens@fda. |

|Ed |Tripp |Abbott Laboratories |edward.tripp@ |

|Steve |Ward |Lilly |stw@ |

|Taku |Watanbe |PMDA |watanabe-taku@pmda.go.jp |

I. Vocabulary Update - Bron Kisler

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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.

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II. Update From Patient Safety Work Group – Lise Stevens

Lise presented the attached material.

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V. Common Product Model – Ed Tripp

Ed 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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End of Document

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

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