BRIDG R3.0.1 CDISC Review and Comment Period – Comments due by 7 May 2010
This release of BRIDG is being taken through the ISO Joint Initiative Council (JIC) process which will include HL7 and ISO ballots as well as this CDISC review and comment cycle. This process is being undertaken to advance BRIDG to a global, open, publicly-available standard. To download and comment on BRIDG R3.0.1, please click here.
BRIDG Release 3.0.1 Now Available
You can download the full release here (zip).
Alternatively you can download separate files:
This release of BRIDG is being taken through the ISO Joint Initiative Council (JIC) process which will include HL7 and ISO ballots as well as another CDISC review and comment cycle. This process is being undertaken to advance BRIDG to a global, open, publicly-available standard. The current plan calls for this to effort to complete in mid to late 2010.
This release includes changes made as a result of the CDISC review in late 2010. Comments and resolutions available here (xls).
The Biomedical Research Integrated Domain Group (BRIDG) Model is a domain analysis model representing protocol-driven biomedical/clinical research. It was developed to provide an overarching model that could readily be understood by domain experts and would provide the basis for harmonization among standards within the clinical research domain and between biomedical/clinical research and healthcare.
Three important streams of development have been brought together into this collaborative framework:
- CDISC – In 2003, CDISC started constructing a Domain Analysis Model to support harmonization of their models as well as with HL7.
- NCI – In 2004, the NCI's caBIG initiative joined the CDISC BRIDG efforts to construct a structured protocol representation and to achieve interoperability among clinical trials research in cancer
- In early 2005, the BRIDG model was been adopted by the HL7 RCRIM Technical Committee as the RCRIM Domain Analysis Model and is being implemented at NCI.
The model emerged from an unprecedented collaborative effort among clinical trial experts from CDISC, the US National Institutes of Health (NIH)/National Cancer Institute (NCI), the Food and Drug Administration (FDA), Health Level Seven (HL7), and other volunteers. The modeling effort is using the HL7 Development Framework (HDF).
This structured information model is being used to support development of data interchange standards and technology solutions that will enable harmonization between the biomedical/clinical research and healthcare arenas.
The BRIDG Model serves to bridge standards, as well as organizations and various communities, including academic research institutions and pharmaceutical product development organizations and related service and technology providers. It is also bridging the gap between clinical research and healthcare.
