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Regulated Clinical Research Information Management Technical Committee of hl7


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Regulated Clinical Research Information Management Technical Committee of HL7


2004-10-29 Teleconference Minutes


ATTENDEES:






Barry Brown (Mortata Instrument)

Becky Kush (Clinical Data Interchange Standards Consortium - CDISC)

Bill Friggle (Sanofi-Synthelabo)

Bob Hizer (Eli Lilly and Company)

Cara Willoughby (Eli Lilly and Company)

Chris Tolke (Bayer Corporation)

Doug Fridsma (University of Pittsburgh)

Fred Wood (Procter & Gamble Pharmaceuticals)

Gunther Schadow (Regenstrief Institute)

Julie Evans (Clinical Data Interchange Standards Consortium - CDISC)

Kathy Hollinger (US Food and Drug Administration)

Kris Spahr (Wyeth Pharmaceuticals)

Kristin O’Connor (Boehringer Ingelheim Pharmaceuticals)

Lee Evans (Intrasphere Technologies, Inc.)

Linda Quade (Eli Lilly and Company)

Mark Ifshin (AstraZeneca Pharmaceuticals)

Michael Gould (GlaxoSmithKline)

Norman Gregory (US Food and Drug Administration)

Rachel Richesson (University of South Florida)

Randy Levin (US Food and Drug Administration)

Rob Borotkanics (Agency for Healthcare Research and Quality - AHRQ)

Smita Hastak (National Cancer Institute Center for Bioinformatics)

Steve Gitterman (US Food and Drug Administration)




Note: on the teleconference attendee list, your company is stated as in the HL7 membership directory unless you say otherwise during the roll-call.




ACTION ITEMS: the following people were assigned action items during this meeting

Scott Getzin, Norman Gregory, Bob Hizer, Mark Ifshin, Linda Quade, Gunther Schadow, Kris Spahr, Barbara Tardiff


Stability Project

Presenter: Norman Gregory

Reviewed project description. Project is focused on e-submission to FDA.


Ballot plans: Groups within the FDA are still coming together on this effort and on how FDA will use it. A demonstration of the Nike (sp?)/Clark model to FDA personnel is planned for the near term. The HL7 standard is derived from that model, and is meant to carry the same functionality at minimum. The current model also needs to be re-presented to pharma, where there are still concerns that additional functionality in support of industry use cases could become part of e-submission requirements. There is still a need for education on the distinction between the HL7 standard and the FDA guidance on use of the standard for e-submission – particularly stressing that the guidance will be subject to separate approval through the usual FDA guidance process.
Action Items:

  • Kris Spahr will get together with Scott Getzin and others from the PhRMA taskgroup to assess industry acceptance from the industry perspective.

  • Norman Gregory will accelerate efforts within the FDA to come to consensus on moving forward.

  • Norman Gregory will get together with Bob Hizer, Mark Ifshin, Kris Spahr and others to address industry concerns.

  • Norman Gregory will have an update on 11/05 on the project, and whether the team feels the standard is ready to announce for ballot with support from both industry and FDA. Further work during the 30-day announcement period will be evaluated on the 12/03/04 RCRIM teleconference to decide whether the ballot will actually be offered by RCRIM in this upcoming ballot cycle.



Annotated ECG Project (aECG)

Presenter: Barry Brown

Project description not available for review.


Ballot Plans: An updated implementation guide was distributed to RCRIM in early October (5th or 6th). This is the version that will be balloted as an informative document, unless Barry receives suggestions for change. Chris Tolk has agreed to compare the aECG model with the CDISC SDTM model. A project conference call to discuss this effort will be set up and announced on the project listserver. Anyone interested in participating should join that listserver (rcrimaecg - there is a link under COMMITTEES on the HL7 home page for subscribing to listservers)
Action Items:

  • Linda Quade will post the updated implementation guide on the RCRIM website, and will redistribute it to the RCRIM listserver in a message specifically targeted at the vote to be taken on 11/05 on readiness for ballot announcement.

  • Scott Getzin will prepare a project description for discussion at a later teleconference.



Structured Product Labeling (SPL)

Presenter: Kris Spahr

Reviewed project description and status. There are now about 70 “members” of this team; about 60% are actively involved in subteams, documentation, etc. SPL Release 1 is ANSI approved. The Implementation Guide is essentially complete. The team is working on extensions for Release 2, and on awareness. The team has just lost it’s original specification developer and ballot editor. Gunther Schadow and Steve Gitterman will serve as short-term ballot editors for this cycle. Volunteers are needed to take up the ballot editor role longer term.


Ballot Plans:

  • The Implementation Guide was first available in September, 2005. An Updated version will be ready for informative ballot in the upcoming ballot cycle.

  • Current plans are to ballot “release 1.1” and release 2 simultaneously at committee level. Release 1.1 has minor changes which will probably pass unchallenged, and which are critical to immediate implementation of release 1. Release 2 encompasses major changes and extensions of the model. It is not clear whether it is possible to include two releases of the same specification in the same ballot. There was also concern about the confusion this would create, and the quality of the responses received. Linda suggested that the minor changes might be corrections that could be made with a “technical correction letter” from John Quinn.

  • The question arose about changes being balloted in CDA, but which will flow through to SPL and other structured documents. It is not clear whether it is either appropriate or desirable to open these same changes for comment in the other structured documents; and the mechanism for excluding them is also not clear.


Action Items:

  • Gunther Schadow and Linda Quade will investigate the issues around balloting of two releases in the same ballot cycle; and around “adopting” changes balloted by CDA without reballoting them in derivitave specifications.


Discussion and Acceptance of Project Proposal: Problem Space Model to RIM Mapping Project

Presenter: Becky Kush

The CDISC Problem Space Model (PSM) will be used by RCRIM to develop HL7 specifications. To facilitate this, an RCRIM project is proposed that will map the PSM to the HL7 RIM. The PSM was presented and discussed at the CDISC Interchange the week of October 18, but the mapping project was not discussed per se. There will be a meeting on 11/05 at NCI to discuss messages the NCI wants to develop from the PSM. The CDISC PSM may be renamed; the term “problem space model” did not resonate with a number of attendees at the CDISC Interchange, and had some unintended implications.


Linda pointed out that some wording in the project description suggested the mapping document would be turned over to the RCRIM model management team, and requested that this be removed since the model management team is not responsible for developing and recommending changes to any RCRIM models. The function of that team is to assure availability of the latest version of each model, and to provide and administer a process for updating the models.
Motion made and seconded (passed).

Remove any wording in the project description that indicates that the model management team will be the recipient of the PSM to RIM mapping.

Discussion:


  • This motion contains no decision on how the mapping will be applied to RCRIM models. Possibilities are (1) to include application to other models within this project; (2) to establish a new project to evaluate impact on other models, once the PSM to RIM mapping is completed.

Vote: 15 aye; 0 nay; 0 abstain


Motion madeand seconded (passed).

RCRIM accepts sponsorship of the PSM to RIM Mapping Project

Discussion: none
Vote: 15 aye; 0 nay; 0 abstain
Action Items:


  • Barbara Tardiff (project leader) will revise the project description in accordance with the motion above.

  • Linda Quade will update the RCRIM project roster to reflect acceptance of the project; and will forward project description to the ARB once the description has been updated..

Motion was made and seconded to adjourn

Meeting was adjourned 11:06am EDT
respectfully submitted

Linda Quade, presiding chair



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