BRIDG

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 post-marketing 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). ­

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

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

To subscribe to this service, go to the HL7 Listservices Welcome Page

1. Select Subscribe to List Services
2. Fill in Name, Organization, e-mail and password
3. Select type of mail

Mail 

You receive copies of messages posted to the list as they are delivered and distributed (most common method)

Digest 

Each night, around 12:00 am, you will receive a single email message containing all the messages contributed to the list that day. At the top of the message will be a numbered list of the subjects in that digest, followed by the complete messages themselves. Digest recipients will not receive messages sent to segments.

Digest with Attachments 

The same as a digest, but in MIME format so that the individual messages' formatting is preserved. Some email clients such as Outlook will show the digest as a series of attachments. Digest recipients will not receive messages sent to segments.

1. Scroll down the list to Regulated Clinical Research Information Management
2. Check bridg BRIDG Harmonization
3. Scroll to the bottom of the page and check the confirmation statement
4. Press Request Subscription

You will receive an e-mail confirmation. Follow the instructions on the email to activate your account. Once an account has been confirmed you can mail to the listserv using the mailing address bridg@lists.hl7.org

Open Discussion Questions from Balloting Process

The following questions are awaiting subject matter expertise before they can be resolved. Please edit the discussion question page directly or email the BRIDG SCC at bridgTHC-L@list.nih.gov and someone will load your comments for you.

1. Proposed new definition and example for PerformedGeneticObservationResult.mutationTypeCode (row 7)
   • Discussion on PerformedGeneticObservationResult.mutationTypeCode
2. Need examples for ProteinIdentifier.identifier (row 12)
   • Discussion on examples for ProteinIdentifier.identifier
3. Need clarification and storyboard for examples for AminoAcidSequence(row 18)
   • Discussion on examples and storyboard for AminoAcidSequence
4. Need overall clarification on GeneticReference (rows 49 & 50)
   • Discussion on overall clarification on GeneticReference
5. Proposed Change to MolecularBiomarker Definition (row 52)
   • Discussion on Proposed Change to MolecularBiomarker Definition
6. Proposed Change to MolecularBiomarkerGroup Definition (row 53)
   • Discussion on Proposed Change to MolecularBiomarkerGroup Definition
7. Proposed Change to Pathway Definition (row 54)
   • Discussion on Proposed Change to Pathway Definition
8. Proposed Change on Protein Definition (row 55)
   • Proposed Change on Protein Definition
9. Need clarification on comments re attribute geneticRegionOfInterest (row 6)
   • Clarification on comments re attribute geneticRegionOfInterest
10. Need clarification on comments re AminoAcidSequenceFeature (row 20)
    • Clarification on comments re AminoAcidSequenceFeature
11. Need clarification on comments re Biomarker (row 21)
    • Clarification on comments re Biomarker
12. Need clarification on comments re Biomarker.name (row 22)
    • Clarification on comments re Biomarker.name
13. Need clarification on comments re Exon (row 23)
    • Clarification on comments re Exon
14. Need clarification on comments re Gene.symbol (row 24)
    • Clarification on comments re Gene.symbol
15. Need clarification on comments re GeneIdentifier.identifier (row 26)
    • Clarification on comments re GeneIdentifier.identifier
16. Need clarification on comments re GeneticReference.sequenceIdentifier (row 28)
    • Clarification on comments re GeneticReference.sequenceIdentifier
17. Need clarification on comments re GeneticVariation (row 29)
    • Clarification on comments re GeneticVariation
18. Need clarification on comments re Intron (row 30)
    • Clarification on comments re Intron
19. Need clarification on comments re MessengerRNA (row 31)
    • Clarification on comments re MessengerRNA
20. Need clarification on comments re MessengerRNAIdentifier Example (rows 32 & 33)
    • Clarification on comments re MessengerRNAIdentifier Example
21. Need clarification on comments re MessengerRNAIdentifier Definition (row 34)
    • Clarification on comments re MessengerRNAIdentifier Definition
22. Need clarification on comments re NucleicAcidSequenceFeature.orientation (row 35)
    • Clarification on comments re NucleicAcidSequenceFeature.orientation
23. Need clarification on comments re Chromosome (row 36)
    • Clarification on comments re Chromosome

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