Control/Query Meeting Minutes (Heading 1) · Web viewRegulated Clinical Research Information Management (RCRIM) Technical Committee Meeting Minutes January 8-11, 2006 Monday Q3 Attendees

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

January 8-11, 2006

Monday Q3AttendeesName Affiliation E-mail AddressBecky Angeles ScenPro/NCICB [email protected] Birmingham J&J [email protected] Dunlop Infermed [email protected] Ebina PMDA [email protected] Evans CDISC [email protected]

Doug FridsmaUniversity of Pittsburgh (CDISC) [email protected]

Terry Hardin IBM [email protected] Helton CDSIC [email protected] Hernandez IBM [email protected] Jaffe Intel [email protected] Kacher Oracle [email protected]

Bron KislerDuke Clinical Research Institute [email protected]

Rebecca Kush CDISC [email protected] Leizear FDA [email protected] Levin FDA [email protected] McKinnon McKinnon Associates [email protected] Nakai PDMA [email protected] Pistre Sanofi Aventis [email protected] Pochon Covance [email protected] Rock Global Submit [email protected] Rosen Pfizer [email protected] Simoen EMEA [email protected] Spahr Wyeth [email protected] Speakman NCI [email protected] Sue Thompson NCPDP [email protected] Tripp Abbott Laboratories [email protected] Velezis Booz Allen Hamilton [email protected] Ward Lilly [email protected] Willoughby Eli Lilly and Company [email protected]

I. Accepting minutes

Minutes accepted from last working group meeting

II. Teleconference Decisions

a) Monday

10-11 Stability meeting to remain as same.

1:30-2:30 every other week SPL Process meeting.

b) Tuesday

10-11 RCRIM conference call every other week (next call on Jan 23rd).

11-12:30 Eastern Time RPS every other week same week as the RCRIM call (next one on Jan 16th).

2:00-3:00 RPS technical team meeting every forth week (next one on the Jan 16th)

c) Wednesday

Remove RPS meeting.

d) Thursday

10:30-11:30 Vocabulary every other Thursday. Propose moving it to the hour 11:00-12:00. (next one on Jan 18th)

e) Friday

10:00-12:00 Pharmacogenomics/CDISC SDTM Next call on Friday Jan 26th. (every other week)

III. Harmonization Report

No update given. (see Q2 Tuesday Harmonization Activity)

IV. Project Updates

a) Stability Pilot

Team is working on the X-Form for stability. An update will be scheduled for a future RCRIM call.

b) Lab message R2 pilot

The team has been focusing on getting the SDTM pharmacogenomics domain refined. There was a DIA conference on the voluntary submission of pharmacogenomics data. The conference was well attended. The intent is to start up testing with the intent of looking at results and lessons learned in the third quarter.

There is a question as to whether or not we want to extend into the preclinical arena with the message. The message would be needed to carry the raw genetic data. This message would then be carried within an RPS message.

The pharmacogenomics will examine the work effort for incorporating preclinical data and report back on the level of effort and scope of the work.

c) New Project Proposals

Don Kacher proposed that eDCI become a project. This will be reviewed in Q4.

It was proposed that we review the project initiation document at a future teleconference.

New projects should be registered with the HL7 PMO.

V. co-chair election

One candidate for co-chair, Ed Helton was elected to a two term.

Monday Q4 - eDCIName Affiliation E-mail Address

Becky Angeles ScenPro/NCICB [email protected] Dunlop Infermed   [email protected] Daigoro Ebina PDMA [email protected] Fridsma University of Pittsburgh (CDISC) [email protected] Hardin IBM [email protected] Helton CDSIC [email protected] Hernandez IBM [email protected] Kacher Oracle [email protected] Kush CDISC [email protected] Leizear FDA [email protected] Levin FDA [email protected] McKinnon McKinnon Associates [email protected] Nakai PDMA [email protected] Pochon Covance [email protected] Rock Global Submit [email protected]

Name Affiliation E-mail AddressKris Spahr Wyeth [email protected] Tripp Abbott Laboratories [email protected] Velezis Booz Allen Hamilton [email protected] Ward Lilly [email protected]

I. eDCI

Don Kacher presented on electronic data collection instrument (eDCI).

Don has provided his presentation in HTML format in the attached zip file.

This has been running as an early adopter project and Don recommends that we formalize this as a RCRIM project.

The difference between ODM and the eDCI analysis is the globally identified data elements. The question was raised as to a business case for an eDCI message.

It was suggested that a project description developed and that this be reviewed and discussed at a future RCRIM meeting.

Tuesday Q1 - Protocol RepresentationName Affiliation E-mail Address

Becky Angeles ScenPro/NCICB [email protected] Baronoski BMS [email protected] Coon NCI/EVS [email protected] Dunlop Infermed [email protected] Evans CDISC [email protected] Fridsma University of Pittsburgh

(CDISC)[email protected]

Margaret Haber NCI [email protected] Hardin IBM [email protected] Helton CDSIC [email protected] Hernandez IBM [email protected] Jones GSK [email protected] Kacher Oracle [email protected] Kisler Duke Clinical Research

[email protected]

Rebecca Kush CDISC [email protected] Leizear FDA [email protected] Levin FDA [email protected] Pistre Sanofi Aventis [email protected]

Name Affiliation E-mail AddressPhil Pochon Covance [email protected] Quinn NCI [email protected] Rock Global Submit [email protected] Rosen Pfizer [email protected] Simoen EMEA [email protected] Spahr Wyeth [email protected] Speakman NCI [email protected] Ed Tripp Abbott Laboratories [email protected] Velezis Booz Allen Hamilton [email protected] Wade CSC [email protected] Ward Lilly [email protected] Willoughby Eli Lilly and Company [email protected]

I. Protocol Representation

Becky Kush gave the following presentation.

Clinical Trial Registry has been incorporated into Protocol representation and the question is whether or not there will be separate deliverables for Clinical Trial Registries.

The overall question is which static structures in a protocol become dynamically transmitted to stakeholders.

There is a use case for a V3 message for FDA to receive Summary information, trial design, data, statistical plan and analysis datasets from sponsors to be then loaded into the Janus database.

Discussion will continue Q3 Tuesday.

Tuesday Q2- Joint with PHER/Patient SafetyName Affiliation E-mail Address

Rita Altamore WADOH [email protected] Angeles ScenPro/NCICB [email protected] Case AAVLD [email protected] Coon NCI/EVS [email protected] Dalta CAL2CAL [email protected] Dunlop Infermed [email protected] Ebina PDMA [email protected] Eckerson Northrop Gruman/CDC [email protected] Evans CDISC [email protected]

Name Affiliation E-mail AddressCharles Fisher NYS DOH [email protected] Flashman NPSA [email protected] Fridsma University of Pittsburgh

(CDISC)[email protected]

Peter Goldschmidt Agency for Healthcare Research and Quality

[email protected]

Margaret Haber NCI [email protected] Hardin IBM [email protected] Helton CDSIC [email protected] James Blue Wave/NPSA [email protected] Jones GSK [email protected] Kisler Duke Clinical Research

[email protected]

Cent Koelewijn NICTIZ [email protected] Kush CDISC [email protected] Leizear FDA [email protected] Levin FDA [email protected] McGinness SNOMED [email protected] McQuill CA DHS [email protected] Madra GPI Canada [email protected] Nakai PDMA [email protected] Nunez Oracle [email protected] Peterson FDA/CVM [email protected] Pistre Sanofi Aventis [email protected] Quinn NCI [email protected] Reeves NCICB [email protected] Rocca Novartis [email protected] Rock Global Submit [email protected] Rosen Pfizer [email protected] Siegel Atlas Development [email protected] Simoen EMEA [email protected] Smith FDA [email protected] Spahr Wyeth [email protected] Speakman NCI [email protected] Lise Stevens FDA [email protected] Tripp Abbott Laboratories [email protected] Velezis Booz Allen Hamilton [email protected] Walden Duke Medical Center [email protected] Walker Mead Walker Consulting [email protected] Ward Lilly [email protected] Willoughby Eli Lilly and Company [email protected]

I. AE domain representation

Lise Stevens presented information on PHER SIG and PSSIG activities

A discussion about whether or not GIN or other PHER-related messages need to be included in BRIDG. Doug Frisma suggested that the AE modeling focus on the dynamic aspect of AE reporting and determine the scope based on that work.

II. Harmonization Activity

Mead Walker reported that the harmonization proposals from ICSR were accepted. Where we are moving forward with message to ballot have we defined the coded elements and do we need to suggest vocabulary domains for those messages.

III. GIN Ballot reconciliation

The GIN message was balloted for DSTU for the second time. The ballot reached Quorum. It is probable that some of those comments and responses will be substantial.

Overview of ballot was presented:

HL7 Version 3 Standard: Patient Safety; Generic Incident Notification, Release 1

Aff. Neg. Abst. NVAffiliate 0 0 5 0Consultant 0 1 1 0General Int. 1 0 0 0Payor 0 0 0 0Pharmaceutical 2 0 1 0Provider 13 0 0 0Vendor 2 7 0 0

Totals 18 8 7 0% of Votes 54.55% 24.24% 21.21% 0.00%Quorum 100.00% Approval 18

IV. Ballot reconciliation for ICSR

Attach ICSR Ballot presentation.

ICSR Met the requirements for Quorum and to pass ballot. Based on the initial review there appears to me no substantive changes required based on the fact that cardinality is being relaxed and not tightened.

HL7 Version 3 Standard: Patient Safety; Individual Case Safety Reporting, Release 2

  Aff. Neg. Abst. NVAffiliate 0 4 1 0Consultant 0 1 1 0General Int. 11 1 0 0Payor 0 0 0 0Pharmaceutical 2 0 1 0Provider 13 0 0 0

Vendor 2 7 0 0

Totals 28 13 3 0% of Votes 63.64% 29.55% 6.82% 0.00%Quorum 100.00% Approval 28

Assuming that the ballot can be reconciled the project will test this for the next 6-24 months and incorporate any recommendation for ICH/ISO E2B requirements into the ballot following the test period. At report on the gaps will be presented at the September Working Group meetings.

It is suggested that a quarter be scheduled for HL7 orientation at the WG meeting in Germany.

Tuesday Q3 - Clinical Study Design MessageName Affiliation E-mail Address

Becky Angeles ScenPro/NCICB [email protected] Birmingham J&J [email protected] Case AAVLD [email protected] Coon NCI/EVS [email protected]

Robert Dunlop Infermed [email protected] Ebina PDMA [email protected] Evans CDISC [email protected] Fridsma University of Pittsburgh

(CDISC)[email protected]

Margaret Haber NCI [email protected] Hardin IBM [email protected] Helton CDSIC [email protected] Hernandez IBM [email protected] Jones GSK [email protected] Kacher Oracle [email protected] Kush CDISC [email protected] Leizear FDA [email protected] Levin FDA [email protected] Nakai PDMA [email protected] Pochon Covance [email protected] Quinn NCI [email protected] Reeves NCICB [email protected] Rock Global Submit [email protected] Rosen Pfizer [email protected] Simoen EMEA [email protected] Smith FDA [email protected] Spahr Wyeth [email protected] Speakman NCI [email protected] Ed Tripp Abbott Laboratories [email protected]

Marti Velezis Booz Allen Hamilton [email protected] Wade CSC [email protected] Ward Lilly [email protected] Willoughby Eli Lilly and Company [email protected]

I. Protocol Representation subprojects cont.

There is a use case for a V3 message for FDA to receive Summary information, trial design, data, statistical plan and analysis datasets from sponsors to be then loaded into the Janus database.

This could be termed a CDISC Submission project.

STDM is represented on the file showing the various data packages and the inclusion of SEND were raised as a concern. It was stated that the ability to do business with third party business partners for SEND data is perhaps a larger use case than the submission. Also there is a large economic impact in implementing a SEND message due to the large LIMS systems used by companies. Embedding the process from end to end is a use case.

There is a potential use case for site start up with trial design and eligibility criteria.

It was suggested that we develop a DMIM and then use an incremental approach to begin to move to a 1 to 1 correspondence with the BRIDG.

From the TCS meeting projects must define a project lead, project sponsor, more than one implementer and a projected timetable for ballot. Projects then get registered with the PMO.

The project proposal for eDCI will be reviewed at a future session.

Ed Tripp and Becky Kush will update the project roster to reflect the current project status.

Jason Rock and Becky Kush will develop a project proposal for the use case described above.

Tuesday Q4 - Joint with Patient SafetyName Affiliation E-mail Address

Becky Angeles ScenPro/NCICB [email protected] Birmingham J&J [email protected] Coon NCI/EVS [email protected] Ebina PDMA [email protected] Fridsma University of Pittsburgh [email protected]

(CDISC)Margaret Haber NCI [email protected] Hardin IBM [email protected] Helton CDSIC [email protected] Jones GSK [email protected] Kacher Oracle [email protected] Kisler Duke Clinical Research

[email protected]

Rebecca Kush CDISC [email protected] Leizear FDA [email protected] Levin FDA [email protected] McGinness SNOMED [email protected] Nakai PDMA [email protected] Parker Thomson Micromedex [email protected] Pistre Sanofi Aventis [email protected] Pochon Covance [email protected] Quinn NCI [email protected] Reddy IBM [email protected] Reeves NCICB [email protected] Rock Global Submit [email protected] Simoen EMEA [email protected] Smith FDA [email protected] Spahr Wyeth [email protected] Speakman NCI [email protected] Lise Stevens FDA [email protected] Tripp Abbott Laboratories [email protected] Velezis Booz Allen Hamilton [email protected] Wade CSC [email protected] Walden Duke Medical Center [email protected] Ward Lilly [email protected] Willoughby Eli Lilly and Company [email protected] Wood Intermountain Healthcare [email protected]

I. Vocabulary update for RCRIM

Bron Kisler presented an update on the CDISC terminology projects

Margaret Haber presented on NCI EVS

II. eDCI Project

Don Kacher presented the following Project Charter.

Don will distribute an updated scope statement via the RCRIM Listserve. Comments are welcome. A decision on the initiation as a project will be handled on a future teleconference.

Wednesday Q1 – Joint meeting with EHR

I. Attendees

Attendance captured by EHR TC, please refer to the minutes from EHR.

II. Overviews

We held a joint meeting with hosted by the EHR TC. Linda Fischetti introduced the meeting with a recap of discussion that occurred at the HL7 Working group meeting in San Antonio, in 2006.

There was a presentation from Lenel James from the conformance workgroup. At the eClinical Forum is working on profile descriptions for critical capabilities for clinical research utilizing EHR Systems.

Attached is the EHR/CR functional profile

A brief overview of the EuroRec “Q-Rec: European Quality Labeling and certification of Electronic Health Records Systems” was presented. Information is available at http://www.eurorec.org/

Under development at ISO are the following:

ISO 21298 Health informatics -- Functional and structural roles

ISO 22600 Health informatics -- Privilege management and access control

ISO 25237 Health informatics -- Pseudonymisation

Ed Tripp presented an overview of RCRIM

III. Discussion

The EHR TC will meet and decide where there are ongoing activities that need to be worked on in collaboration with RCRIM. RCRIM offered a BRIDG Tutorial for one of the EHR Quarters. It was suggested that an EHR Tutorial be scheduled as an RCRIM quarter or a teleconference. Prior to a teleconference a PowerPoint presentation will be distributed on the RCRIM Listserve.

DOD - Nancy Orvis - she will take lead on approaching HL7 leadership regarding the existence of DAMs within HL7, and meeting with the individual TCs to determine potential touch points.

Wednesday Q2 – BRIDG updateName Affiliation E-mail Address

Becky Angeles ScenPro/NCICB [email protected] Baronoski BMS [email protected]

Bob Birmingham J&J [email protected] Coon NCI/EVS [email protected]

Jane Diefenbach DCRI [email protected] Ebina PDMA [email protected] Evans CDISC [email protected] Fridsma University of Pittsburgh

(CDISC)[email protected]

Margaret Haber NCI [email protected] Hardin IBM [email protected] Helton CDSIC [email protected] Hernandez IBM [email protected] Jones GSK [email protected] Kelly IBM [email protected] Kisler Duke Clinical Research

[email protected]

Wayne Kubick Lincoln Technologies (CDISC)

[email protected]

Rebecca Kush CDISC [email protected] McGinness SNOMED [email protected] Nakai PDMA [email protected] Pistre Sanofi Aventis [email protected] Quinn NCI [email protected] Reeves NCICB [email protected] Rosen Pfizer [email protected] Spahr Wyeth [email protected] Speakman NCI [email protected] Ed Tripp Abbott Laboratories [email protected] Ward Lilly [email protected]

I. BRIDG update

Doug Fridsma presented the following update on BRIDG

We identified the need for a BRIDG education meeting to take place between BRIDG leadership and the SPL leadership team in order to identify domain experts for the mapping of SPL into the BRIDG.

Doug reviewed the BRIDG model with the committee.

There is a need to map the complex coded concepts in BRIDG with the HL7 complex data types.

Wednesday Q3 –RPSName Affiliation E-mail Address

Becky Angeles ScenPro/NCICB [email protected] Birmingham J&J [email protected] Coon NCI/EVS [email protected] Diefenbach DCRI [email protected] Dunlop Infermed [email protected] Ebina PDMA [email protected] Evans CDISC [email protected] Fridsma University of Pittsburgh

(CDISC)[email protected]

Margaret Haber NCI [email protected] Hardin IBM [email protected] Helton CDSIC [email protected] Hernandez IBM [email protected] Jones GSK [email protected] Kacher Oracle [email protected] Kubick Lincoln Technologies

(CDISC)[email protected]

Rebecca Kush CDISC [email protected] Leizear FDA [email protected] Levin FDA [email protected] Nakai PDMA [email protected] Pistre Sanofi Aventis [email protected] Quinn NCI [email protected] Rock Global Submit [email protected] Rosen Pfizer [email protected] Simoen EMEA [email protected] Spahr Wyeth [email protected] Speakman NCI [email protected]

Ed Tripp Abbott Laboratories [email protected] Velezis Booz Allen Hamilton [email protected] Ward Lilly [email protected]

I. RPS update

Jason Rock presented the following on RPS

The following items were discussed following the presentation

II. Guidance for Identifier UUID or OID?

There was a desire expressed at an RPS working group meeting that RCRIM make a consistent decision for all standards. This may not be appropriate.

UUID/GUID’s are randomly generated with no internal structure where OID’s has a definable structure with root that can lead back to an organization and extensions off the root.

GSK just completed a test submission with a recommendation for the use of OID.

If more than one group has to contribute you should use a UUID but, if the use cases dictate that only one organization contributes then it can be managed by an OID.

No recommendation from RCRIM on this issue.

III. How much to test

It was suggested that at least one successful test against each storyboard be a minimum requirement to assure the standard meets the requirements documented in the storyboards.

It was suggested that at least two organizations test each storyboard to assure that a single successful test was not achieved in error.

Recommendation is to test at least every storyboard you want to support (each balloted) a minimum of two times by two organizations (at least once by each organization). It is recommended that a business process subject matter expert be involved in the review of the test submission.

IV. When to go to ballot?

RPS release one should be balloted when testing is complete and BRIDG harmonization is complete. Additionally, a review of future features be added in release two to determine the risk of issues with backward compatibility. The team will target the May ballot.

Wednesday Q4 – Joint with Clinical GenomicsName Affiliation E-mail Address

Becky Angeles ScenPro/NCICB [email protected] Birmingham J&J [email protected] Bolte GE Healthcare [email protected] Coon NCI/EVS [email protected]

Brian Drohan UMASS [email protected] Ebina PDMA [email protected] Evans CDISC [email protected] Haber NCI [email protected] Helton CDSIC [email protected] Hernandez IBM [email protected] Huges MGH [email protected] Jones GSK [email protected] Kelly IBM [email protected] Kisler Duke Clinical

Research [email protected]

Wayne Kubick Lincoln Technologies (CDISC)

[email protected]

Kiyohito Nakai PDMA [email protected] Pistre Sanofi Aventis [email protected] Pochon Covance [email protected] Quinn NCI [email protected] Schenner RAND/UCLA [email protected] Shabo IBM Research [email protected] Simoen EMEA [email protected] Spahr Wyeth [email protected] Tripp Abbott [email protected] Ullman-Cullere HPCGG Partners mullman [email protected]

Geraldine Wade CSC [email protected]

Grant Wood Intermountain Healthcare

[email protected]

Chauanbo Xu Perlegen [email protected]

I. Clinical Genomics

Phil Pochon presented the following:

Amnon Shabo presented the following as activities for the Clinical Genomics SIG.

Thursday Q1 – Joint with Cardiology SIGName Affiliation E-mail Address

Becky Angeles ScenPro/NCICB [email protected] Baronoski BMS [email protected] Birmingham J&J [email protected] Ebina PDMA [email protected] Evans CDISC [email protected] Fridsma University of Pittsburgh

(CDISC)[email protected]

Ed Hammond Duke [email protected] Hanover Philips [email protected] Helton CDSIC [email protected] Hernandez IBM [email protected] Honeycutt Duke [email protected] Jones GSK [email protected] Kisler Duke Clinical Research

[email protected]

Peggy Leizear FDA [email protected] Levin FDA [email protected] McCourt Duke [email protected] Nakai PDMA [email protected] Pistre Sanofi Aventis [email protected] Pochon Covance [email protected] Reeves NCICB [email protected] Rock Global Submit [email protected] Shadow [email protected] Simoen EMEA [email protected] Spahr Wyeth [email protected] Tripp Abbott Laboratories [email protected] Velezis Booz Allen Hamilton [email protected] Walden Duke Medical Center [email protected] Walker Mead Walker Consulting [email protected]

Steve Ward Lilly [email protected]

I. SPL Ballot Reconciliation

The ballot passed with the following results:

  Aff. Neg. Abst. NVAffiliate 0 0 5 0Consultant 1 0 0 0General Int. 13 0 0 0Payor 0 0 0 0Pharmaceutical 14 1 1 1Provider 0 0 13 1Vendor 10 0 0 0

Totals 38 1 19 2% of Votes 63.33% 1.67% 31.67% 3.33%Quorum 96.67% Approval 26

Negative comments and suggestion were persuasive and amendments were made per the suggestions. The one negative vote will be withdrawn.

A vote was taken on approval of the changes; 25 for, 0 against, and 6 abstain. The changes were approved.

A question was raised regarding the name “Implementation Guide” and if there is a better name.

Jason Rock presented the use of X-Forms (an open standards form for creating XML) and its potential use for SPL.

There was a discuss at the pharmacy TC about adding distinguishing characteristics such as flavors or gluten free.

II. Update on Cardiology and Tuberculosis Data Standards

Duke partnered with CDISC for the development of therapeutic data standards.

Anita Walden and Brian McCourt presented the following:

Overlaps with BRIDG were identified. Domain analysis model will be discussed by cardiology in their Q3 session.

Thursday Q2 –Unfinished BusinessName Affiliation E-mail AddressBecky Angeles ScenPro/NCICB [email protected] Birmingham J&J [email protected] Evans CDISC [email protected] Fridsma University of Pittsburgh

(CDISC)[email protected]

Ed Helton CDSIC [email protected] Jones GSK [email protected] Kush CDISC [email protected] Leizear FDA [email protected] Pistre Sanofi Aventis [email protected] Pochon Covance [email protected] Reeves NCICB [email protected] Rock Global Submit [email protected] Rosen Pfizer [email protected] Tripp Abbott Laboratories [email protected]

Marti Velezis Booz Allen Hamilton [email protected] Wade CSC [email protected] Ward Lilly [email protected]

I. Unfinished business

ICSR ballot comments have been resolve and reached agreement to withdraw negative comments.

There is an intent to ballot RPS in the May ballot session. As the test results are obtained the team will review the intent to ballot as the ballot cycle gets closer.

II. Planning for next WG meeting

Phil requested at least a half session joint with clinical genomics. We will target the same quarter as this WG meeting.

It was suggested that we use first or second quarter on Tuesday as an educational session on HL7 and RCRIM. Ed Tripp and Becky Kush will develop the materials.

The Joint meeting with EHR should be targeted as a BRIDG tutorial.

RPS will need a quarter. If we go to ballot we should reserve a separate quarter for ballot reconciliation (preferable back to back quarters).

It is suggested that we request rooms for the 6 quarters following the formal RCRIM agenda.