Representatives of a variety of organizations participate in the BRIDG project. The project structure that is evolving to support that collaboration follows:
- The BRIDG Advisory Board: The BRIDG Advisory Board (BAB) was established in mid-2005. Its mission is “… to ensure that the further development, maintenance and governance of the model continue in a collaborative, open and coordinated manner. The Board will also manage the scope of the model and ensure that it is maintained.” The Board is led by Julie Evans, CDISC and Doug Fridsma, MD, caBIG/University of Pittsburgh, and is comprised of representatives from all of the four key stakeholder groups (CDISC, HL7, caBIG/NCI, and FDA).
- The Technical Harmonization Group: The BRIDG Technical Harmonization Group was established in September, 2005 to assist in the effort of harmonizing subproject models into the BRIDG model.
- BRIDG Subprojects: As the BRIDG project matures, more of the work to extend the model and add detail is performed in the context of subproject groups: small groups that focus on a defined area of the clinical trial protocol lifecycle.Examples of these groups include the Cancer Adverse Events Reporting System (caAERS) development group at the City of Hope and the caBIG CTMS Lab Interface, Study Calendar, and Financial Billing Special Interest Groups.
Other subprojects include the harmonization of the CDISC Study Data Tabulation Model (SDTM), the NCI’s Clinical Trial Object Model (CTOM), the CDISC-HL7 Protocol Representation Group, the Clinical Trial Registry (CTR), and the CDISC Trial Design Model.
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