RCRIM Meeting Minutes

9-12 January 2006

Monday, 9 January 2006

I. Monday Q3 - 1:30-3:00

Business meeting; Accepting minutes; teleconference decisions; harmonization report; co-chair elections

Linda Quade

a) Acceptance of minutes; Teleconference decisions; Co-chair elections

[Word document: LQ]

Co-Chair Electionso John Quinn and Ed Hammond conducted co-chair elections.o John Quinn announced new co-chairs as Randy Levin and Ed Tripp.

Introductionso Attendees introduced themselves and indicated their affiliations

Approval of Minuteso Minutes from last working group meeting were approved.

Agenda for Jan WG Meetingo Barbara reviewed agenda for this working group meeting.

Linda reviewed actions and decisions at teleconferences held since last WG meeting.

There is a need for someone else to work with Julie Evans on the publication activity. There is about 30 hours of training on a 50-page document. On an ongoing basis there is one intense week (almost full time), per ballot period and the remaining time is about 4 hours per week. Those interested should contact Julie Evans and cc the co-Chairs.

Linda reviewed teleconference scheduled. In addition the following projects have teleconferences: Regulated Product Submission, Stability, and Vocab. SPL and Pharmacogenomics also have teleconferences—these should be announced on RCRIM ListServe as well.

Recommendation/action item: Barbara or one of co-chairs will schedule teleconferences as follows:

o RCRIM Every other Friday 11-12o RCRIM Vocabulary: Every Thursday; 11 AM Easterno Product Submission: Every Wednesday, 11 AM Easterno Product Stability: Every Monday, 10 AM Easterno Clinical Genomics – Phil Pochon to inform co-chair

RCRIM Teleconference schedule for upcoming cycleo 1/27 WGM agenda discussiono 2/10 Discuss ballot readiness for inclusiono 2/24 Firm up WGM agendao 3/10 Approve any outstanding Reconciliation and final ballot approvedo NOTE 3/19 is the Ballot Content Deadlineo 4/7 Firm up WGM agenda

o 4/21 Finalize WGM agenda

o

o Team leads reviewed the ballot results. CT Lab Release 2, GIN and Stability implementation all failed to pass this cycle. Participation in balloting was limited by holiday period. Ballot results will be discussed in detail during ballot reconciliations on Wednesday.

o Charlie Mead proposed that standards be first balloted as DTSU. He proposed that specifications are actually design documents and need to be implemented at least three times before balloting.

b) RCRIM Harmonization Update

Linda presented an overview of RCRIM proposals (all concerned vocabulary).

II. Monday Q4 - 3:30-5:00

Host Clinical Genomics and Patient Safety SIG Semantic WebVocabulary Harmonization Proposals for approval (Vocab team and project teams);Harmonization Proposals in progress (Vocab team and project teams);

Bron Kisler, Lise Stevens-Hawkins, Margaret Haber

[Powerpoint, Pavla Frazier]

Pavla reviewed the recent US Government Directives re ethnicity and race and HL7 changes. This changes the cardinality of race and ethnicity to 0-* from 0-1. CDC is the authoritative source and HL7 has agreed to reference CDC as the authoritative source. Allows for some modifications for foreign studies. Self identification and multiple characterization allowed by OMB.

c) Harmonization Proposals

[Word documents, PP]

Harmonization Proposals for approval

Phil Pochon reviewed Vocabulary Harmonization Proposals. Two proposals generated the most comment: ActReason codes are to capture why a particular visit occurred and ResearchSubjectRoleBasis.

Motion that RCRIM vocabulary group be allowed to move forward with this proposal as described above.

Seconded and approved 21 aye, 0 nay, remainder abstentions.

Harmonization Proposals in progress Phil also discussed Proposal for next cycle re Creation of ECGCollection domain

with value set STD12, ML12, EASI. Also under discussion is Proposal for ECGCollection domain to be created in

Observation Method domain and 3 coded values related to orientation of patient during ECG. This one is still under discussion and will be reviewed in further detail at an upcoming teleconference.

d) Semantic Web

Eric Neumann presented overview and led discussion re W3C Semantic Web for Healthcare and Life Sciences Interest Group.

[Powerpoint, EN]

Healthcare and Life Science Interest Group launched in November 2005. Co-

chairs Tonya Hongsermeier (Partners Healthcare) and Eric Neumann (Teranode). Hypothesis is that technology could be used to bridge Design and Implementation. Potential of multiple linked ontologies.

Semantic lens to study safety—“safety lens” Same data can be rearranged for different uses.

Tuesday, 10 January 2006

III. Tuesday Q1 – 9:00-10:30

Emerging Role of BRIDGDiscussion Session: Use of BRIDG in HL7 specification development

BRIDG Advisory Board; committee members

Charlie Mead reviewed the roots and history of BRIDG (for benefit of attendees who are new to BRIDG). The CDISC Board agreed to build the DAM so that the CDISC semantics are defined and then be able to map those semantics to HL7. About halfway through the process of developing the model, the protocol representation group engaged and the scope became protocol driven research.

Julie reviewed the BRIDG Advisory Board charter and membership.

[powerpoint, JE]

Doug gave an overview of the BRIDG organization and structure and some of the feedback the team has received to date.

There was discussion around the focus of the model on protocol driven research and the broader scope of RCRIM. Steve Ward asked who is the governance of the BRIDG model. The three stakeholders (CDISC, NCI and RCRIM) will decide and there it is modeled after open source.

IV. Tuesday Q2 - 11:00-12:30

Overview of BRIDG model content. Class-level model walkthrough

Doug Fridsma

[Visio Diagram Smita]

Doug continued in an overview of the BRIDG model.

There were a number of points of discussions about the domain scope. A Visio diagram has been created that maps out the various business process spaces—including but not limited to Execute clinical trials.

Joyce brought up that it is important that we also include the business processes at a clinical site.

A process model of the development of a drug was shared. The original model was supplied by Intrasphere. A review of the BRIDG model occurred with the dynamic (business process) representation shown. After development of the process model, the static (logical) model will be married with the business model.

There were a number of discussions related to scope of domain and relationship to RCRIM. Charlie mentioned that there may be a 1-many to 1-many relationship of domain model (such as BRIDG) to DMIM. RCRIM may pull from one or more domain models to construct a DMIM. It has not been determined at this time whether BRIDG will include all of the domain areas in which RCRIM has an interest.

VI. Tuesday Q3 - 1:30-3:00

BRIDG model management (distribution, commenting, management process)

BRIDG Advisory Board

Doug continued overview/discussion about the BRIDG model.

In addition to the bottom up approach it is probably time to take a top down look at what the “process” spaces are. For example current view places clinical genomics under clinical research activities but clinical genomics may contribute to multiple business process spaces. Steve Ward, Terry Hardin, Mead Walker, Barbara Tardiff, Rich Kirk, Ed Tripp and Allen Jones expressed an interest in working this top down activities. Doug mentioned that the top down could be entered into EA and then harmonized with the existing work.

Action item: Ed Tripp and Allen Jones will help reconcile the BRIDG business model.

VII. Tuesday Q4 - 3:30-5:00

Subdomain Development (eDCI, Adverse Events, CTLab, aECG, Product Submission, SDTM, …)

Subdomain Leaders

Doug discussed the projects that are underway: eDCI (joint effort ORcale, NCI, CDISC), CTOM harmonization with BRIDGE, harmonization of existing messages, AE models.

Don Kacher discussed the eDCI

[Word Document: DK]

The electronic data capture initiative is joint NCI, CDISC message that is fast tracked. The intent is to enable communication of Data Collection Instrument Definition and data between applications. Must be a HL7 V3 message.

Ed Tripp mentioned that there was a PhRMA white paper that might be of interest. Barbara raised question as to whether we have the proper level of visibility within RCRIM. Discussion and decision was deferred pending Don’s presentation.

Don reviewed the project process and provided an overview of the analysis model of the semantic related to communicating the specifications for a Data Collection Instrument.

Wednesday, 11 January 2006

VII. Wednesday Q1 – 9:00-10:30

Stability Implementation Guide – ballot reconciliationRegulated Product Submission message (request for ballot approval)

Norman Gregory, Norbert BittnerJason Rock, Randy Levin, Barbara Tardiff

[Powerpoint, ballot spreadsheet NG]

Norman reviewed the process used to develop and ballot the implementation guide and highlighted the main areas of comment and discussion.

Norman reviewed the ballot comments on the Stability Message Implementation Guide. There were substantive changes that need to be addressed.

Norman will work through the comments and prepare a response. This will be discussed on a teleconference and the reconciliation posted on the RCRIM and request withdrawal of negative. Then the implementation guide will be re-balloted if substantive changes.

VII. Wednesday Q2 – 11:00-12:30

Regulated Product Submission message – continued

Jason Rock, Randy Levin, Barbara Tardiff

Jason Rock reviewed that Regulated Submission Model Structure, the RMIM and sample submissions. There is a desire to take it to ballot in March. Discussion on whether or not to bring it to ballot needs to be made.

[Visio, powerpoint]

VIII. Wednesday Q3 - 1:30-3:00

Host Patient Safety: GIN (generic incident notification) – ballot reconciliation

Lise Stevens-Hawkins, Clive Flashman

Clive Flashman presented an update on WHO’s effort to established a group focused on patient safety taxonomy.

Lise gave an update on implementation of ICSR at FDA across the various product areas. Anita Benson also proposed changes related to the pre-market side re tracking business process and capturing other data related to business process. Anita has also made a proposal for a clinical study CMET. Patient safety will schedule teleconferences to discuss further before next WG meeting. In addition we will plan on two joint sessions to explore ICSR domain model and these issues.

For May cycle plan to ballot ICSR Implementation Guide.

Chris Foye reviewed the ballot response for GIN. They are mostly minor and can be resolved without substantive changes to specification. Plan is to ballot next cycle as DSTU.

The WHO is developing Patient Safety Event Taxonomy. There are several alternative starting-points including the HL7 taxonomy.

FDA has been working on implementing the ICSR message through CDRH. There is an inter-center workgroup to look at implementing across the agency. They are gathering requirements from Veterinary Medicine and from Food.

IX. Wednesday Q4 - 3:30-5:00

Host Clinical Genomics;CTLaboratory, R2 – ballot reconciliationTopics per CG SIG

Phil Pochon, Amnon Shabo

Phil presented an overview of the history of the CT Lab message and RCRIM and the genomic CMET

Phil provided an overview of the results of the ballot of the CT Lab Release 2. All of the ballots were from 2 organizations Oracle and the VA. Comments were all minor and can be easily resolved.

[powerpoint, spreadsheet]

Next steps were discuss. Plan to meet with FDA for additional review , modify ballot to incorporate minor changes and use approved Clinical genomics CMET (as DTSU). Plan to ballot in coming cycle again as DTSU and actively promote review of May ballot. Will tap into larger PG working group.

Amnon presented an update of activities within Clinical Genomics.

[powerpoint-AS]

Thursday, 12 January 2006

XI. Thursday Q1 – 9:00-10:30

Protocol Representation/Registry Message Becky Kush

[powerpoint]

Becky Kush presented the Protocol Representation project objective and basis for protocol content and the history of the project. Seven use cases were listed and three were identified as high priority.

1. Support the CDISC STDM v3.1.12. Support study tracking database (Trial Registry Use Case)3. Support development (transmission) of the Clinical Trial Protocol

Document Trial Design Model is being led as by Diane Wold. Version 1 was published as

part of SDTM v3.1. Version 2 is expected by Spring 2006.

WHO International Clinical Trial Registry Platform Project has work being done to define 20 elements for trial registration. They have asked the PR group to identify a codelist for 20 elements.

There is interest in developing a clinical trial registry message to address the WHO and other use cases. For the next quarter the expectation is a re-write of the charter, and analysis model and a planned target ballot cycle. The team does need a modeler to help with this. Randy think he may be able to find someone or funding for this.

The Protocol Representation team will work on the analysis model in anticipation of discussing at the next meeting and use as a basis for developing HDF artifacts.

It would be good to have EUDRACT involvement—Romain Eude (EMEA) will try to identify a resource. This will be a good topic for the April meeting in Berlin.

Target will be to have an analysis model of the Clinical Trial Registry project to discuss at the April meeting and then at the May WG.

The Clinical Trial Registry project will be added to the RCRIM conference call agenda.

XII. Thursday Q2 – 11:00-12:30

Unfinished business; Planning for next WG meeting

Co-Chairs

Helen Stevens presented an overview of the Canadian Public Health Surveillance Project. Helen Stevens provided an update on the Canadian Public Health Surveillance project. The objective is to implement a single public health solution for all of Canada. Functional components are Communicable Disease Case Management, Outbreak Management, Immunization Management (registry and service delivery), Alerts Management, Work Management and Materials & Vaccine Inventory Management. There are four tracks: Procurement, Jurisdiction and Implementation, Pan-Canada Special Task Group and Pan-Canadian Standards. Looking for Implementable (not through full ballot) HL7 V3 standards. The solution will be capable to adjust to the evolution of the standard. There is significant overlap with GIN and the teams will arrange to work together.

[powerpoint]

Ballots planned for next cycle: o GIN, DSTUo Stability Implementation Guide, Informativeo CT Lab Release 2, DSTUo Regulated Product Submission, DSTU

Regulated Product Submission will petition board for initial ballot as DSTU. We need to confirm whether or not we need Board approval to ballot other specifications as DSTU that have already been balloted at the committee level.

Agenda for May 2006Monday Q3 Business Meeting and out of cycle meeting update.Monday Q4 Host Clinical Genomics and PSSIG

Tuesday Q1 BRIDG UpdateTuesday Q2 eDCI UpdateTuesday Q3 Protocol Representation and review of Clinical Trial Registry Analysis Tuesday Q4 RPS Ballot reconciliationWednesday Q1 Stability IG UpdateWednesday Q2 Host Patient SafetyWednesday Q3 Host Patient Safety GIN Ballot Wednesday Q4 Host Clinical Genomics CT Lab ballot reconciliationThursday Q1 SPL update and ballot reconciliation?Thursday Q2 Unfinished businessThursday Q3 Joint meeting with EHR

Action item: Ed will update the RCRIM project list

Meeting was adjourned.