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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 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 | + | :::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. | *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. | ||
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===Bi-Weekly Conference Call Information=== | ===Bi-Weekly Conference Call Information=== | ||
| − | Alternating Tuesdays, 10-11 AM (US Eastern Time, GMT -4 DST). | + | Alternating Tuesdays, 10-11 AM (US Eastern Time, GMT -4 DST). For the date of the next call, see the [http://www.hl7.org/Special/committees/bridg/index.cfm BRIDG WG Web Page] |
Please consult http://www.timeanddate.com/worldclock/fixedtime.html?iso=20140923T1000&p1=784 for your local times. | Please consult http://www.timeanddate.com/worldclock/fixedtime.html?iso=20140923T1000&p1=784 for your local times. | ||
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The BRIDG listserv is bridgwg@lists.hl7.org | The BRIDG listserv is bridgwg@lists.hl7.org | ||
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| + | ===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. | ||
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| + | #[[StudyProtocolVersion Attributes Moving to Study or StudyProtocol]] | ||
| + | #[[Adding ID data type and associated impact analysis]] | ||
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| + | ---- | ||
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| + | ===Closed Discussion Questions for BRIDG Work Group=== | ||
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| + | 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. | ||
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| + | #[[Reconciling Performer and Assessor]] | ||
| + | #[[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. | 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. | ||
| − | #Proposed new definition and example for PerformedGeneticObservationResult.mutationTypeCode (row 7) | + | #CLOSED - Proposed new definition and example for PerformedGeneticObservationResult.mutationTypeCode (row 7) |
#*[[Discussion on PerformedGeneticObservationResult.mutationTypeCode]] | #*[[Discussion on PerformedGeneticObservationResult.mutationTypeCode]] | ||
| − | #Need examples for ProteinIdentifier.identifier (row 12) | + | #CLOSED - Need examples for ProteinIdentifier.identifier (row 12) |
#*[[Discussion on examples for ProteinIdentifier.identifier]] | #*[[Discussion on examples for ProteinIdentifier.identifier]] | ||
| − | #Need clarification and storyboard for examples for AminoAcidSequence(row 18) | + | #CLOSED - Need clarification and storyboard for examples for AminoAcidSequence(row 18) |
#*[[Discussion on examples and storyboard for AminoAcidSequence]] | #*[[Discussion on examples and storyboard for AminoAcidSequence]] | ||
| − | #Need overall clarification on GeneticReference (rows 49 & 50) | + | #CLOSED - Need overall clarification on GeneticReference (rows 49 & 50) |
#*[[Discussion on overall clarification on GeneticReference]] | #*[[Discussion on overall clarification on GeneticReference]] | ||
| − | #Proposed Change to MolecularBiomarker Definition (row 52) | + | #CLOSED - Proposed Change to MolecularBiomarker Definition (row 52) |
#*[[Discussion on Proposed Change to MolecularBiomarker Definition]] | #*[[Discussion on Proposed Change to MolecularBiomarker Definition]] | ||
#Proposed Change to MolecularBiomarkerGroup Definition (row 53) | #Proposed Change to MolecularBiomarkerGroup Definition (row 53) | ||
#*[[Discussion on Proposed Change to MolecularBiomarkerGroup Definition]] | #*[[Discussion on Proposed Change to MolecularBiomarkerGroup Definition]] | ||
| − | #Proposed Change to Pathway Definition (row 54) | + | #CLOSED - Proposed Change to Pathway Definition (row 54) |
#*[[Discussion on Proposed Change to Pathway Definition]] | #*[[Discussion on Proposed Change to Pathway Definition]] | ||
| − | #Proposed Change on Protein Definition (row 55) | + | #CLOSED - Proposed Change on Protein Definition (row 55) |
#*[[Proposed Change on Protein Definition]] | #*[[Proposed Change on Protein Definition]] | ||
| − | #Need clarification on comments re attribute geneticRegionOfInterest (row 6) | + | #CLOSED - Need clarification on comments re attribute geneticRegionOfInterest (row 6) |
#*[[Clarification on comments re attribute geneticRegionOfInterest]] | #*[[Clarification on comments re attribute geneticRegionOfInterest]] | ||
| − | #Need clarification on comments re AminoAcidSequenceFeature (row 20) | + | #CLOSED - Need clarification on comments re AminoAcidSequenceFeature (row 20) |
#*[[Clarification on comments re AminoAcidSequenceFeature]] | #*[[Clarification on comments re AminoAcidSequenceFeature]] | ||
| − | #Need clarification on comments re Biomarker (row 21) | + | #CLOSED - Need clarification on comments re Biomarker (row 21) |
#*[[Clarification on comments re Biomarker]] | #*[[Clarification on comments re Biomarker]] | ||
| − | #Need clarification on comments re Biomarker.name (row 22) | + | #CLOSED - Need clarification on comments re Biomarker.name (row 22) |
#*[[Clarification on comments re Biomarker.name]] | #*[[Clarification on comments re Biomarker.name]] | ||
| − | #Need clarification on comments re Exon (row 23) | + | #CLOSED - Need clarification on comments re Exon (row 23) |
#*[[Clarification on comments re Exon]] | #*[[Clarification on comments re Exon]] | ||
| − | #Need clarification on comments re Gene.symbol (row 24) | + | #CLOSED - Need clarification on comments re Gene.symbol (row 24) |
#*[[Clarification on comments re Gene.symbol]] | #*[[Clarification on comments re Gene.symbol]] | ||
| − | #Need clarification on comments re GeneIdentifier.identifier (row 26) | + | #CLOSED - Need clarification on comments re GeneIdentifier.identifier (row 26) |
#*[[Clarification on comments re GeneIdentifier.identifier]] | #*[[Clarification on comments re GeneIdentifier.identifier]] | ||
| − | #Need clarification on comments re GeneticReference.sequenceIdentifier (row 28) | + | #CLOSED - Need clarification on comments re GeneticReference.sequenceIdentifier (row 28) |
#*[[Clarification on comments re GeneticReference.sequenceIdentifier]] | #*[[Clarification on comments re GeneticReference.sequenceIdentifier]] | ||
| − | #Need clarification on comments re GeneticVariation (row 29) | + | #CLOSED - Need clarification on comments re GeneticVariation (row 29) |
#*[[Clarification on comments re GeneticVariation]] | #*[[Clarification on comments re GeneticVariation]] | ||
| − | #Need clarification on comments re Intron (row 30) | + | #CLOSED - Need clarification on comments re Intron (row 30) |
#*[[Clarification on comments re Intron]] | #*[[Clarification on comments re Intron]] | ||
| − | #Need clarification on comments re MessengerRNA (row 31) | + | #CLOSED - Need clarification on comments re MessengerRNA (row 31) |
#*[[Clarification on comments re MessengerRNA]] | #*[[Clarification on comments re MessengerRNA]] | ||
| − | #Need clarification on comments re MessengerRNAIdentifier Example (row 33) | + | #CLOSED - Need clarification on comments re MessengerRNAIdentifier Example (row 33) |
#*[[Clarification on comments re MessengerRNAIdentifier Example]] | #*[[Clarification on comments re MessengerRNAIdentifier Example]] | ||
| − | #Need clarification on comments re MessengerRNAIdentifier Definition (row 34) | + | #CLOSED - Need clarification on comments re MessengerRNAIdentifier Definition (row 34) |
#*[[Clarification on comments re MessengerRNAIdentifier Definition]] | #*[[Clarification on comments re MessengerRNAIdentifier Definition]] | ||
#Need clarification on comments re NucleicAcidSequenceFeature.orientation (row 35) | #Need clarification on comments re NucleicAcidSequenceFeature.orientation (row 35) | ||
#*[[Clarification on comments re NucleicAcidSequenceFeature.orientation]] | #*[[Clarification on comments re NucleicAcidSequenceFeature.orientation]] | ||
| − | #Need clarification on comments re Chromosome (row 36) | + | #CLOSED - Need clarification on comments re Chromosome (row 36) |
#*[[Clarification on comments re Chromosome]] | #*[[Clarification on comments re Chromosome]] | ||
| − | #Need clarification on comments re InVivoCharacterization (row 9, FDA) | + | #CLOSED - Need clarification on comments re InVivoCharacterization (row 9, FDA) |
#*[[Clarification on comments re InVivoCharacterization]] | #*[[Clarification on comments re InVivoCharacterization]] | ||
Return to [[Main Page]] | Return to [[Main Page]] | ||
Latest revision as of 18:54, 3 October 2016
Biomedical Research Integrated Domain Group (BRIDG) Work Group
Contents
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
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.
- StudyProtocolVersion Attributes Moving to Study or StudyProtocol
- 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.
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.
- CLOSED - Proposed new definition and example for PerformedGeneticObservationResult.mutationTypeCode (row 7)
- CLOSED - Need examples for ProteinIdentifier.identifier (row 12)
- CLOSED - Need clarification and storyboard for examples for AminoAcidSequence(row 18)
- CLOSED - Need overall clarification on GeneticReference (rows 49 & 50)
- CLOSED - Proposed Change to MolecularBiomarker Definition (row 52)
- Proposed Change to MolecularBiomarkerGroup Definition (row 53)
- CLOSED - Proposed Change to Pathway Definition (row 54)
- CLOSED - Proposed Change on Protein Definition (row 55)
- CLOSED - Need clarification on comments re attribute geneticRegionOfInterest (row 6)
- CLOSED - Need clarification on comments re AminoAcidSequenceFeature (row 20)
- CLOSED - Need clarification on comments re Biomarker (row 21)
- CLOSED - Need clarification on comments re Biomarker.name (row 22)
- CLOSED - Need clarification on comments re Exon (row 23)
- CLOSED - Need clarification on comments re Gene.symbol (row 24)
- CLOSED - Need clarification on comments re GeneIdentifier.identifier (row 26)
- CLOSED - Need clarification on comments re GeneticReference.sequenceIdentifier (row 28)
- CLOSED - Need clarification on comments re GeneticVariation (row 29)
- CLOSED - Need clarification on comments re Intron (row 30)
- CLOSED - Need clarification on comments re MessengerRNA (row 31)
- CLOSED - Need clarification on comments re MessengerRNAIdentifier Example (row 33)
- CLOSED - Need clarification on comments re MessengerRNAIdentifier Definition (row 34)
- Need clarification on comments re NucleicAcidSequenceFeature.orientation (row 35)
- CLOSED - Need clarification on comments re Chromosome (row 36)
- CLOSED - Need clarification on comments re InVivoCharacterization (row 9, FDA)
Return to Main Page
