Project Summary for BRIDG (Biomedical Research Integrated Domain) Domain Analysis Model (DAM) (ISO/JIC Project)
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Project Details
Number | 538 View Ballot Items List (with NIBs) |
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Name | BRIDG (Biomedical Research Integrated Domain) Domain Analysis Model (DAM) (ISO/JIC Project) |
Sponsor(s) | Biomedical Research and Regulation Work Group |
Co-Sponsor(s) | |
Steering Division | Clinical |
Description | The scope of this project is to ballot the static components of the BRIDG DAM. The scope of the BRIDG model is Protocol-driven research and its associated regulatory artifacts, i.e. the data, organization, resources, rules, and processes involved in the formal assessment of the utility, impact, or other pharmacological, physiological, or psychological effects of a drug, procedure, process, subject characteristic, or device on a human, animal, or other subject or substance plus all associated regulatory artifacts required for or derived from this effort, including data specifically associated with post-marketing adverse event reporting. Facilitate ongoing harmonization of the Clinical Data Standards Consortium (CDISC) Biomedical Research Integrated Domain (BRIDG) Model. |
Project Facilitator | Julie Evans; Edward Tripp |
Status | Archived |
SD Approval Date | Sep 11, 2009 |
TSC Approval Date | Sep 22, 2009 |
Type | ISO JIC Ballot Project |
Objectives / Deliverables | This ballot will include the set of static components of DAM artifacts as defined in HDF Requirements. These static components include: - Classes, attributes, relationships, state machines, constraints Not included: - Datatypes (BRIDG uses HL7 R2), value sets for coded attributes The behavioural components will not be balloted as a whole, but instead will be balloted by individual projects. - September 2009: BRIDG SSC brings work in progress to RCRIM Working Group Meeting - January 2010: - BRIDG SSC develops BRIDG (Release 3) 2 layer approach by January 2010 - RCRIM issues Notification of Intent to Ballot in May 2010 - Informative document - February 2010 - May 2010: RCRIM prepares ballot for May 2010 ballot - May 2010: RCRIM ballots BRIDG Release 1 - May 2010 - Ongoing: BRIDG SSC gives regular updates at RCRIM teleconferences |
Next Milestone Date | 2013 September WGM |
Project End Date | 2014 September WGM |
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Dependancies | - ISO JIC Ballot of BRIDG: The BRIDG Board of Directors and BRIDG Semantic Coordination Committee need to ensure that the ISO balloting and HL7 balloting keep BRIDG aligned and the various balloting processes do not cause divergence. The intent is to have one approved version of BRIDG. To be more specific, the BRIDG version balloted in the ISO JIC and through this project will be the same content. - BRIDG Semantic Coordination Committee (SCC), formerly known as the Technical Harmonization Committee (THC) development of Release 3, 2 layer approach - RIM datatype R2 transition (M&M project) CDISC/FDA/NCI Project - Project ID: 455 205, 494 |
Project Document Repository | http://wiki.hl7.org/index.php?title=BRIDG_as_DAM |
Backwards Compatibility | |
External Vocabularies | |
Products | Domain Analysis Model (DAM) |
Joint Copyright? | |
External Pjt Collaborators | CDISC |
Realm | - Choose One - |
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Ballot Cycle Info | 2010 May Ballot Cycle Info: INFORMATIVE Ballot results: Met basic vote requirements for approval. 24 Negative votes to reconcile Document Name: HL7 Version 3 Domain Analysis Model: Biomedical Research Integrated Domain (BRIDG), Release 1 Ballot Code: V3DAM_BRIDG_R1_TBD NIB Submitted By: Edward Tripp |
Misc Notes | May 2013: Published NE 2013; PMO archiving. March 2013: Received ANSI approval for Technical Report of HL7 Version 3 Domain Analysis Model: Biomedical Research Integrated Domain (BRIDG), Release 1. PMO set status as Ready for Normative Edition Publication. Project Team does not need to do any further work. Nov 2012: TSC approved a publication request for HL7 Version 3 Domain Analysis Model: Biomedical Research Integrated Domain (BRIDG), Release 1 as an informative document and registration with ANSI as a Technical Report, from TSC tracker # 2406. As of 2012-09-01: Project restarted. BRIDG project team re-writing new NWIP for submission September 2012. 2011Dec: Per L. Laakso The Bridg project at PI 538 is an ISO/JIC project (ISO/CD 14199). PMO changed it to be an ISO/JIC project type. 2010Nov(LL): updated dates per RCRIM three-year plan. cyclical development indicative of informative ballot developemnt Jan cycles, ballot May cycles, publication and renewed development in September cycles. 2010July: added repository URL Sept 2009: PMO changed from 3-Year Plan item to Active Project |
U.S. Govt Interest? | |
USRSC Approval | |
FMG Approval | |
ARB Approval | |
Start Date | Sep 11, 2009 |
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