CDISC



RCRIM WGM 2007 Cologne, Germany

Attendee List

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Meeting Minutes

AGENDA

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Q3

Monday 30April2007

WGM Cologne

1. Minutes approved of 17April2007

2. New Projects - deferred

3. Current Project Review

- Stability update (Norman Gregory)

i. Pilot – using standard data implementation guide/standard releases 1Q/2Q of 2008 to complete pilot

ii. Input tool a problem

iii. 7 companies in pilot

iv. x form/viewing tool

v. use global summit for xform access for download

We have developed an Xform In-put tool to covert stability data to the schema with validation. The URL to the web site by Jason Rock is . Downloads for Mozzila Firefox and the XForm plug in, download for MozzIE plug in for IE and the Stability XForm Downloads. My government computer did not strip out the java script and the add and delete rows work. Extract the files to a folder, in that folder there will be a folder created named "stability_XForm", in that folder open folder named "stability", in that folder open folder named "XForms", and open the StabilityForms.xhtml file in Mozilla Firefox or IE.

We are trying to find a vendor to get the import function of the In-put tool to work so companies that have there data in a spreadsheet don't have to re-enter it.

The plan is to ballot the IG and release 2 of the stability standard in January 2008 or May 2008. It all is a function of when the stability pilot is finished and changes made to the IG and stability standard based on the pilot. For the pilot the XML stability file will be viewed by a viewer that Up-To-Data developed. This is not necessarily the same viewer that FDA would use, but follows the same principles.

- SPL – Randy L/Bob Birmingham

- Bob asked for update form working group. Randy Levine noted that SPL working with CDRH. Want to extend SPL for devices – unique device identifier – Extend product description for device descriptor. Peggy L. working on revised version. Send around for review on Q2 Thursday

- ICSR/PS/RPS updates later in meeting

- CTLab – PGX updates later

- RPS – Jason Rock – no new requirements

- DTSU. Scope -- did we do what we said that we would do? A ballot issues did you do what we said you are to do. CEN to be involved in Release 2 for European interface.

- Steve Ward said still uncertainty between HL7 V2 and CEN (have not approved Release 1 as yet). Need to resolve release 1 to everybody’s satisfaction – confusion of plan re: geography

- Ian Shepherd will be representatve from CEN (for CEN contract with European Commission)

- BRIDG Comments–.Julie Evans

Normalized models in BRIDGE

i. LAB (NCI/CDISC)

ii. SDTM – CDISC

iii. RPS (RCRIM) patient study calendar

iv. Clinical trail regulatory next

New version and point releases very soon.

- Becky Kush

i. Protocol Representation into BRIDG (use in new exploratory project)

- aECG (Randy L) no new activities

- Terminology/Vocabulary – update by Becky Kush

- CAP/SNOMED) (Randy Levine noted) turned over governance to 9 countries to new SDO -- International Health Terminology Standard Development Organization. Will license SNOMED to individual country.

- No comments regarding harmonization – Mead Walker not present

- Testing standardization kick-off

i. Jason Rock Testing conformance (DTSU) HL7 Board sanction

ii. Implementation conformance to STD Q2

iii. Charlie McKay present for RPS reconciliation

Teleconferences – keep as is for existing projects – new projects (e.g. CDISC Content ExploratoryMessage ) new members to meeting and discuss available times. E. Helton will contact Lillian.

Q4

Monday 30April2007

Robert Dunlap Infermed UK

Barbara McKinnon, McKinnon and Associates

Use of HL7

Gello in

Clinical Trials

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- Object constrained language for VMed Record somewhat competitive with xml/arden. Interface with CDASH.

- OCL Interface with SPL – updates, etc

- Action items:

- Norman Gregory – stability update

i. “Stability message input tool” xform

ii. XML scheme

iii. Study viewer of HL7 estability prototype

Q1

Tuesday 01May2007

Bob Birmingham – RCRIM/HL7 Overview

Becky Kush – CDISC – Regulated Research

Julie Evans – BRIDG

Charlie – BRIDG

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Q2

Tuesday 01May2007

PSSIG – AE _________ representation with BRIDG

GIN Ballot reconciliation with Lise Stevens-Hawkin

Julie James

GIN DSTU overall ballot in May

Clive Flashman – PSSIG new charter/mission

- PHER and RCRIM

- Add to meeting minutes

Abdul Malik Sahkir – New projects update

- CT lab reported AT (or indicator) grading

- New storyboard ( ICSR

- Lab text suggests that something adverse is going on

- Grade lab event

Is it definitely applicable - Action Item – redefine with new proposal grade AE indicator present _____ telecom need Phil Pochon

Mead Walker – AE mapping to BRIDG structure

Julie – ICSR/SDTM us in AE domain (needs to be finished)

Q3

Tuesday 1May2007

A. CDISC content to Exploratory Message Project - intro by Becky and Ed

a. SDTM and CDISC RCRIM DMIM to physical may BRIDG

i. Voted NO – would be unnecessary, it circumvents the BRIDG

b. Map BRIDG attributes to HL7RIM DMIM

4Q

Tuesday 01May2007

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PSSIG: ICSR and DSTU (Draft Standard for Trial Use) Lise Stevens-Hawkin

- PPT presentation

- Harmonize AE domain with SDTM (BRIDG) with ICSR

- Vaccine information to generate ingredient identifiers (SPL dependency) change SPL for devices, dietary supplements

Process Framework update by Frieda – Process Framework (Project Life Cycle)

- RCRIM would propose an appropriate project to the Process Framework group

Q1

Wednesday 02May2007

EHR Joint Meeting

HER Update(CCHIT & ballot as international profile)

Bridge update by Julie Evans

EHR global collaboration presentation Isabell(EFPIA)

Q2

Wednesday 02May2007

Vocabulary update to RCRIM – Margret Haber and Bron Kissler

Margaret/Bron slides

BRIDG update – Charles Mead

Tim Buxton – EMEA

ICH/ISO update

7 issues – product name, formulation, etc

Vocabulary issues

Medicinal Product & PU

June 7, 8 London

Details and plan for ISO standards

Adopt/adapt TC21SISO

Terminology interface with HL7/NCI/CDISC for international standard dissemination and maintenance important

Best of Breed with core of volunteers

CDISC and NIC need for ISO/ICH

Interface – NCI/CDISC provider best expertise

Margaret – HL7/RCRIM terminology ____

Patent safety, pharmacy

ICH coming out into SDO issues

Charlie Mead – BRIDG Release 1

- Demonstrated inoperability scenario 4Feb (5) – 5 development teams – success due to BRIDG model. Formal release and formal release process. All elements that had been through harmonization process (e.g. LAB message) cancer trial

- Object mode (CTDM) Static side release1

- Dynamic side/content of Release 1 is provisional

1 major point release per year and 3 minor point releases per year

June 15 date of Release 1

Get Julie to give update review and accuracy

Q3

Wednesday 02May2007

RPS

Ballot reconciliation

- Jason (from Jason)

i. Presented triage of /summary of common comments/duplicative

- Booz – Allen – Hamilton

Keyword Group

context of use and keyword the same

how keyword rather than keyword group – it is a requirement in RIM but optional

7 still a requirement (consensus)

0 oppose

0 abstained

Persuasive

Is this still a requirement but optionally presented

Not a persuasive issue vote

Tell about voters that the requirement was agreed – all not present

Voters must decide to withdraw negative vote

12 agree

0 disagree

5 abstain

Priority number

Remove priority number for reviewable unit (RMIM)

(not persuasive)

In addressing ______________

No longer a priority numbers needed

9 agreed

0 disagree

0 abstain

No persuasive for this reason

9 agreed

0 against

8 abstain

Pfizer

Not in favor vote – not persuasive

Negative vote without a comment is not a vote

Favor of not being persuasive

14 for

0 against

4 abstain

Not persuasive

The specification text is not clear

Agreed to withdraw

Eli Lilly

Add capability to delete a keyword (status) for context of use as we add

- persuasive – add disposition on next release

Considered for future use: add status to keyword (status)

14 agreed (in favor)

0 against

4 abstain

FDA Adoption (FDA implementation)

Novartis

Out of scope as per Ed Hammond

Not related to proposed disposition

13 agreed (disposition not related/relevant)

0 against

4 abstain

Worldwide/Global – 5 companies

Wyeth (quoted line in introduction)

Novartis – do not have representation from all worldwide companies/countries

Remove worldwide concept

GSK – Andrew Marr wording instead of worldwide statement – is comment persuasive. Not meet worldwide needs but some worldwide needs – editorial changes added

Editorial changes – numerous

Persuasive with modification of this disposition

See text J

13 in favor

0 against

4 abstain

Controlled Terms

Merck

Pfizer

Roche

Some degree of persuasion – need editorial changes – no claim for controlled terminology.

- edit clarification

i. The standard contains the concept domains and valve set corresponding to the concept domain are maintained outside the standard controlled terminology outside of the standard to allow changes per HL7 methodology per described in the intro section.

Controlled terms are persuasive with modification.

14 favor

0 against

3 abstain

Testing

Evidence of Testing (continue testing and need better documentation),

Committee would agree – testing leads to risk for release 2 – necessitate changes in release 1. Backward compatible between V2 and V3 was abandoned by HL7 not hamper good change. It was noted that RPS was tested more than any other HL7 v3 standard before normative ballot.

As we deliberate release 2 – get statement form Steve Ward.

Process issues not adequately addressed but must do for better in the future to enhanced. Process issue must have better clarity in the future. Must have this comment withdrawn – adequate disposition to get it withdrawn. It is acknowledge – disposition is to have it withdrawn.

Refer/Comment

Recognize valid comment – HL7 does not provide detailed guidance around testing. RCRIM will work with the Implementation and Conformance TC to help provide such guidance. RCRIM will follow this guidance for release 2 of RPS. In favor of this comment and decide to – 2 command – Steve Ward/Charlie McKay

14 in favor

0 against

4 abstain

Q4

Wednesday 02May2007

*Amnon

Ballot comments reconciled

• Genomic

o Pedigree ballot complete

o Genotype

o Agenda item for telephone call for Phil Pochon update on ballot and terminology

*Anita Walden TB & CV

Brian McCourt

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RCRIM Working Group Meeting Minutes

Thursday, 3-May2007

1. Quarter 1 – The agenda called for Discussion of the CDISC Content to Message Exploratory Project. We discussed several topics that address the scope of the message.

a. Including both animal and human data in this project: The FDA would like to store both animal and human data in the Janus database. It also makes sense to use the same standard to exchange the data. Discussion points:

i. SEND implementation has lagged behind SDTM for Humans. SEND domains are not as mature as SDTM for Humans.

ii. The same HL7 message should be used to interchange both animal and human data.

iii. We would still want to have the animal tox pilot, and describe it more at the CDISC Pilot for Animal Tox data rather than SEND, which makes it sound more like a separate standard.

iv. Animal tox data will also go into Janus

v. When we’re gathering requirements for this project, we should consider both animal and human data.

vi. There is additional work to do in BRIDG and ADaM to ensure that all of the animal data semantics are represented.

vii. The FDA process will fundamentally change in that instead of the FDA working from submitted datasets, the FDA will work from the data repository (Janus).

viii. There was disagreement about whether animal data is included in the current scope, so the group agreed to add an explicit sentence that it is included in the scope.

b. Including ICSR data in interchange files and in the Janus data repository: The FDA would like to have all subject-based data, both pre- and post-marketing, in the Janus database. This is already in scope where ICSR semantics intersect with existing CDISC semantics.

c. Including analysis logic in the submission: The FDA long-term vision is to capture the analysis logic in the submission so that they can re-create the same analysis results as the sponsor. This is currently outside the scope of the project.

d. A proposal was put forward to update the project scope to explicitly include animal data and explicitly exclude computational representation of analysis logic. The ICSR data is included under the BRIDG model where it intersects with the CDISC standard. In addition, we made a few changes to update HL7-specific language (changed “DMIM” and “RMIM” to “CIM”). The group voted on these changes in project scope. The voted 9 in favor, no opposed, 3 abstain. See attached updated project description with change tracking.

1. Quarter 2

a. Unfinished business

i. RPS Ballot Reconciliation – The group finished addressing the ballot reconciliation issues and made updates to the document to capture the agreements.

1. Testing Statement: The group voted on the Testing statement disposition text 9 in favor, 0 opposed, 2 abstain. So that people who download Release 1 will be aware of this reconciliation agreement, this testing statement will be included in the ballot.

2. Hyperlinks: The group voted on the Hyperlinks disposition text 7 in favor, 0 opposed, 4 abstain.

3. EU Requirements: The group voted on the EU Requirements disposition text 8 in favor, 0 opposed, 4 abstain.

4. The group then went through all the comments for affirmative and abstain votes. Jason agreed to resolve the BoozAllenHamilton issues that Marti submitted.

5. The ballot reconciliation spreadsheet will be posted on the website, and then voters will be able to withdraw their negative votes.

ii. More on the Proposal for potential new RCRIM service specification project for cohort selection (clinical research filtered query service) (Charlie Mead) – About 18 months ago, HL7 and OMG formed a joint committee for Service Oriented Architecture (SOA) for HL7. The purpose of the committee is for HL7 to provide the specifications/requirements for business-driven services within healthcare. The motivation came from the increasing knowledge and technology available in the ‘horizontal’ technology space around ‘messaging.’ The deliverable for a given service specification project is a Service Functional Model (SFM), a set of requirements for a service. These SFMs will go through the HL7 DSTU balloting process and then be passed to OMG to put through the OMG RFP process for implementation. Three SFMs have been developed so far. Four new SFMs have been selected for building during 2007, one of which is cohort selection/clinical research filtered query service (which is being run by Charlie Mead). This project needs to provide their deliverable for January ballot (final content deadline ~Nov. 25). An initial analysis suggests that the requirements for a cohort selection service would also satisfy the requirements for a real-time safety monitoring service. Producing an SFM is basically a very organized requirements gathering/analysis process. The end goal is for technology vendors to build the service with standard semantic profiles. The URL for this project is hssp.. Charlie would like to have RCRIM domain experts involved in this process. The project is already underway, so this is RCRIM’s chance to be involved in a project that is especially suited to RCRIM.

1. Action: Charlie – Write a project proposal for this project and bring it back to RCRIM (send to Ed, Randy, and Ed for inclusion on an RCRIM telecon agenda).

iii. Other new upcoming project proposals:

1. SPL Release 4

2. eDCI – The NCI, as sponsor of this project, would like to take it from Early Adopter status to official RCRIM project. The project scope: eDCI is the first of a series of messages that will be the HL7 V3 representation of the ODM. eDCI is an HL7 V3 message that carries the semantics of the questions and vocabulary bindings of a CRF.

3. Frida’s proposal from earlier this week was for RCRIM to embrace the new process and give her feedback, so this isn’t a new project.

iv. RPS Release 2 timing – RPS Release 2 will not be ready for Sep 2007 ballot or Jan 2008 ballot. There was a request by Andrew Marr that RPS Release 2 does not start for more than a couple of years.

b. V3Editing coordination – This item was not discussed since the discussion leader was not present.

c. Planning for next WG meeting – To be addressed at the next teleconference.

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