Health Level Seven and CDISC sign associate charter agreement
The associate charter agreement signed by HL7 and CDISC calls for the creation of a clinical trials special interest group (CTSIG) within HL7 that will convene jointly with representatives from the existing CDISC working teams. Under the terms of the agreement, both organizations will recognize members of the other organization as members of their SIG or Team for the purposes of collaboration, although voting and meetings will be conducted according to the rules of the hosting organization.
According to the partnering companies, the collaboration will focus on identifying the scope and range of data element requirements for the functionality of clinical trials, identifying appropriate controlled vocabulary for encoding those data elements, and identifying or defining messages and objects required to support the specific information exchange needs of clinical research application and as output from those applications.
Representatives from both CTSIG and CDISC will work together under the collaboration, to harmonize the existing CDISC information models with the HL7 Reference Information Model (RIM), evaluate the CDISC submission model and Operational Data Model DTD, conduct DTD cross reference analysis, and determine the applicability of HL7's Clinical Document Architecture (CDA) standard to future CDISC initiatives.
Both organizations hope the collaboration will enable them to expand the value and influence of clinical trials efforts globally and improve drug development and healthcare through the development of harmonized standards.
"CDISC is extremely pleased to have this opportunity to work with HL7 and capitalize on their vast experience in developing data standards for health care," said Wayne Kubick of Lincoln Technologies, and Member of CDISC Board of Directors "Through our joint efforts, we believe we can move even more rapidly to define standards that will benefit all stakeholders in the clinical research process."