This is a significant and groundbreaking achievement for all of us – from CDISC, HL7, NCI, FDA and others who have strived for many years to see this goal come to fruition
Austin, Texas (PRWEB) May 28, 2015
The Clinical Data Interchange Standards Consortium (CDISC) is excited to announce that the International Organization for Standardization (ISO) now recognizes the collaborative Biomedical Research Integrated Domain Group (BRIDG) Model version 3.2 as a published, Final International Standard for clinical research and its link with healthcare. This standard, which had previously passed through the ISO Draft International Standard (DIS) ballot, was unanimously approved on 24 April for publication by the ISO Technical Committee (TC) 215 for Healthcare Informatics.
The BRIDG Model is a domain analysis model representing the realm of protocol-driven research. The BRIDG Model was initiated by CDISC in 2003 to support harmonization among the CDISC standards for clinical research and to bridge research and healthcare. Shortly thereafter, the US National Cancer Institute (NCI), Health Level Seven (HL7) and the U.S. Food and Drug Administration (FDA) joined with CDISC to collaborate on the development and maintenance of this model. BRIDG became a CDISC and HL7 standard in 2012. The BRIDG Board of Directors had also made the decision in 2010 to begin the process of advancing BRIDG to the status of an international standard through the ISO process. Through the Vienna Agreement, ISO standards are automatically adopted by the European Committee for Normalization (CEN).
“This is a significant and groundbreaking achievement for all of us – from CDISC, HL7, NCI, FDA and others who have strived for many years to see this goal come to fruition,” announced Dr. Rebecca Kush, CDISC President and CEO and Leader of the current BRIDG Steering Committee. “We are grateful to the ISO TC215 leadership, especially Dr. Chris Chute, Mike Glickman and Lisa Spellman, for working with us through this entire process, which brings a new type of standard – a non-static model that bridges clinical research with healthcare and is openly available – into the ISO repertoire.”
“BRIDG becoming an ISO standard is a testament to the process and the dedication of the project team,” said Mike Glickman, Chair of ISO Technical Committee 215 for Healthcare Informatics. “BRIDG was improved based on the outreach to a broader pool of experts and the resulting comment disposition. Coordination was achieved before-hand rather than requiring after the fact harmonization.”
In May, as part of the Joint Initiative Council process (Joint Initiative on SDO Global Health Informatics Standardization), CDISC announced the open public review period and a simultaneous HL7 ballot was open for votes and comments on a new draft version of the BRIDG model, version 4.0. The expanded model signifies a major BRIDG release to represent the clinical research domain, now encompassing the larger translational research domain including clinical genomics and pharmacogenomics.
CDISC is a 501(c)(3) global non-profit charitable organization, with over 350 supporting member organizations from across the clinical research and healthcare arenas. Through the efforts of volunteers around the globe, CDISC catalyzes productive collaboration to develop industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol through analysis and reporting, including the use of electronic health records to facilitate the collection of high quality research data. The CDISC standards and innovations can significantly decrease the time and cost of medical research and improve quality, thus contributing to the faster development of safer and more effective medical products and a learning healthcare system. The CDISC Vision is to inform patient care and safety through higher quality medical research.
About ISO TC-215
The BRIDG standard was created in collaboration with ISO Technical Committee (TC) 215, Health informatics. ISO is the world’s largest developer and publisher of international standards. Since its inception in 1998, ISO/TC215 Health informatics covers multiple healthcare domain delivery systems. Working as a global community, ISO/TC215 brings together public and private sectors from more than 50 nations participating and observing the development of health information and HIT standards. ISO/TC215 collaborates with other ISO Technical Committees and liaison organizations from across the globe, such as CDISC, to create consensus standards in health informatics. The American Health Information Management Association (AHIMA) holds the ANSI-delegated ISO/TC215 Secretariat.