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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:
  
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:::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.  
+
:::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===
  
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Alternating Tuesdays, 10-11 AM (US Eastern Time, GMT -4 DST).  ­
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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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To subscribe to this service, go to the [http://www.hl7.org/listservice/index.cfm HL7 Listservices Welcome Page]
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[[Instructions for Subscribing to a List Service]]
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#Select ''Subscribe to List Services''
 
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#Fill in Name, Organization, e-mail and password
 
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#Select type of mail
 
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:;Mail : You receive copies of messages posted to the list as they are delivered and distributed (most common method)
 
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:;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.
 
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:;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.
 
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#Scroll down the list to '''Regulated Clinical Research Information Management'''
 
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#Check '''bridg''' ''BRIDG Harmonization''
 
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#Scroll to the bottom of the page and check the '''confirmation statement'''
 
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#Press '''Request Subscription'''
 
  
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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
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 +
----
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===Open Discussion Questions for BRIDG Work Group===
 +
 
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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]]
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#[[Adding ID data type and associated impact analysis]]
 +
 
 +
 
 +
----
 +
 
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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]]
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#[[Proposed BRIDG Changes for New Imaging Sub-Domain]]
  
  
 
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===Open Discussion Questions from BRIDG 4.0 May 2015 Ballot===
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===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.
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#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]]
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#Proposed Change to Pathway Definition (row 54)
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#CLOSED - Proposed Change to Pathway Definition (row 54)
 
#*[[Discussion on Proposed Change to Pathway Definition]]
 
#*[[Discussion on Proposed Change to Pathway Definition]]
 
#CLOSED - Proposed Change on Protein Definition (row 55)
 
#CLOSED - Proposed Change on Protein Definition (row 55)
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#CLOSED - 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]]
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#Need clarification on comments re GeneticVariation (row 29)
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#CLOSED - Need clarification on comments re GeneticVariation (row 29)
 
#*[[Clarification on comments re GeneticVariation]]
 
#*[[Clarification on comments re GeneticVariation]]
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#Need clarification on comments re Intron (row 30)
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#CLOSED - Need clarification on comments re Intron (row 30)
 
#*[[Clarification on comments re Intron]]
 
#*[[Clarification on comments re Intron]]
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#Need clarification on comments re MessengerRNA (row 31)
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#CLOSED - Need clarification on comments re MessengerRNA (row 31)
 
#*[[Clarification on comments re MessengerRNA]]
 
#*[[Clarification on comments re MessengerRNA]]
 
#CLOSED - Need clarification on comments re MessengerRNAIdentifier Example (row 33)
 
#CLOSED - Need clarification on comments re MessengerRNAIdentifier Example (row 33)

Latest revision as of 18:54, 3 October 2016

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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