BRIDG

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Biomedical Research Integrated Domain Group (BRIDG) Work Group

Introduction

The Biomedical Research Integrated Domain Group (BRIDG) Model is a collaborative effort engaging stakeholders from the Clinical Data Interchange Standards Consortium (CDISC), the HL7 BRIDG Work Group, the US National Cancer Institute (NCI), and the US Food and Drug Administration (FDA). The goal of the BRIDG Model is to produce a shared view of the dynamic and static semantics for the domain of basic, pre-clinical, clinical, and translational research and its associated regulatory artifacts. This domain of interest is further defined as:

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, biologic, cosmetic, food 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 postmarket surveillance and adverse event reporting.
  • Mission: Give complete emphasis and support to the future development and global implementation of this domain analysis model into International Data Model of HL7, CDISC and ISO for the support of healthcare and clinical research.
  • Co-Chairs:
    • Edward Helton PhD, National Cancer Institute, Term ends Jan 2016
    • Mary Ann Slack, Food and Drug Administration, Term ends Jan 2016



Bi-Weekly Conference Call Information

Alternating Tuesdays, 10-11 AM (US Eastern Time, GMT -4 DST). ­For the date of the next call, see the BRIDG WG Web Page

Please consult http://www.timeanddate.com/worldclock/fixedtime.html?iso=20140923T1000&p1=784 for your local times.

Phone Number: 770-657-9270; Passcode: 723389

To view the latest information for this call on the website, visit http://www.HL7.org/concalls/CallDetails.aspx?concall=23203

Use this link to add this call to Outlook or to another iCal-compatible program: http://www.HL7.org/tools/ical.cfm?concall=23203

Minutes and Agendas can be found at http://www.hl7.org/special/committees/bridg/minutes.cfm

Website and Listserv

BRIDG WG Web Page

Information on BRIDG can be found at www.bridgmodel.org

The BRIDG listserv is bridgwg@lists.hl7.org

Instructions for Subscribing to a List Service



Open Discussion Questions for BRIDG Work Group

The following items are open issues for discussion among the BRIDG Work group. Please add your comments by editting the sub-page for the issue of interest.

  1. StudyProtocolVersion Attributes Moving to Study or StudyProtocol
  2. Adding ID data type and associated impact analysis



Closed Discussion Questions for BRIDG Work Group

The following items are closed issues that have already been discussed and resolved among the BRIDG Work group. Please add your comments by editting the sub-page for the issue of interest.

  1. Reconciling Performer and Assessor
  2. Proposed BRIDG Changes for New Imaging Sub-Domain



Archived Discussion Questions from BRIDG 4.0 May 2015 Ballot

The following questions/comments were received for the clinical genomics/molecular biology subdomain of the BRIDG model. Since genomics expertise does not exist in the BRIDG WG, we are actively seeking comments and help from the members of clinical genomics working group in helping resolve the ballot comments and clarify the semantics in the BRIDG model. Please edit the discussion question page directly or email the BRIDG SCC at bridgTHC-L@list.nih.gov and someone will upload the comments for you.

  1. CLOSED - Proposed new definition and example for PerformedGeneticObservationResult.mutationTypeCode (row 7)
  2. CLOSED - Need examples for ProteinIdentifier.identifier (row 12)
  3. CLOSED - Need clarification and storyboard for examples for AminoAcidSequence(row 18)
  4. CLOSED - Need overall clarification on GeneticReference (rows 49 & 50)
  5. CLOSED - Proposed Change to MolecularBiomarker Definition (row 52)
  6. Proposed Change to MolecularBiomarkerGroup Definition (row 53)
  7. CLOSED - Proposed Change to Pathway Definition (row 54)
  8. CLOSED - Proposed Change on Protein Definition (row 55)
  9. CLOSED - Need clarification on comments re attribute geneticRegionOfInterest (row 6)
  10. CLOSED - Need clarification on comments re AminoAcidSequenceFeature (row 20)
  11. CLOSED - Need clarification on comments re Biomarker (row 21)
  12. CLOSED - Need clarification on comments re Biomarker.name (row 22)
  13. CLOSED - Need clarification on comments re Exon (row 23)
  14. CLOSED - Need clarification on comments re Gene.symbol (row 24)
  15. CLOSED - Need clarification on comments re GeneIdentifier.identifier (row 26)
  16. CLOSED - Need clarification on comments re GeneticReference.sequenceIdentifier (row 28)
  17. CLOSED - Need clarification on comments re GeneticVariation (row 29)
  18. CLOSED - Need clarification on comments re Intron (row 30)
  19. CLOSED - Need clarification on comments re MessengerRNA (row 31)
  20. CLOSED - Need clarification on comments re MessengerRNAIdentifier Example (row 33)
  21. CLOSED - Need clarification on comments re MessengerRNAIdentifier Definition (row 34)
  22. Need clarification on comments re NucleicAcidSequenceFeature.orientation (row 35)
  23. CLOSED - Need clarification on comments re Chromosome (row 36)
  24. CLOSED - Need clarification on comments re InVivoCharacterization (row 9, FDA)

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