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

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