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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 post-marketing adverse event reporting.  
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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.  
  
  

Revision as of 19:48, 2 December 2015

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.


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  • Leadership:
    • CoChairs
      • Edward Helton PhD
      National Cancer Institute
      Term ends Jan 2016
      • Mary Ann Slack
      Food and Drug Administration
      Term ends Jan 2016


BRIDG WG Web Page

ListServ Subscribers: send an e-mail to bridgwg@lists.HL7.org.


Listserv

The BRIDG Listserve is bridg@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

Information on BRIDG

The BRIDG Model is a collaborative effort of stakeholders from the Clinical Data Interchange Standards Consortium (CDISC), the HL7 Regulated Clinical Research Information Management Technical Committee (RCRIM TC), the National Cancer Institute (NCI), and the US Food and Drug Administration (FDA) to produce a shared view of the dynamic and static semantics that collectively define a shared domain-of-interest, i.e. the domain of clincial and pre-clinical protocol-driven research and its associated regulatory artifacts.


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