Shirley Williams
Rebecca Kush, Ph.D. CDISC
512.341.9885
www.cdisc.org

HEALTH LEVEL SEVEN AND CDISC SIGN ASSOCIATE CHARTER AGREEMENT

Ann Arbor, Mich.- March 16, 2001 - Health Level Seven, Inc. (HL7) and the Clinical Data Interchange Standards Consortium, Inc., (CDISC) announced today that they have signed an Associate Charter Agreement. This agreement formalizes collaboration between the two groups, which has been ongoing since early 2000.

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 Associate Charter 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. The HL7/CDISC 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. The CTSIG and CDISC representatives will work 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. The Affiliate Charter does not call for transfer of ownership rights to the HL7 Trademarks or Standards or of the CDISC models.

The agreement is beneficial for both organizations. The gains for CDISC include capitalizing on HL7's existing standards efforts, experience base, and ANSI accreditation. HL7's benefits include an expanded reach to the pharmaceutical industry, the FDA and other regulatory agencies, and other stakeholders in the biopharmaceutical industry, and access to domain experts for the Clinical Trials SIG. Both organizations hope to expand the value and influence of clinical trials efforts globally and improve drug development and healthcare through the development of harmonized standards.

"This is really a testimonial for the HL7 RIM and the V3 Message Development Framework (MDF)," says Chuck Meyer, McKesson HBOC, chair of the HL7 Organizational Relations Committee. This agreement is only the beginning of a process that will greatly enhance the communications of all facets of clinical trials information." Wayne Kubick, Lincoln Technologies, and Member of CDISC Board of Directors expressed similar enthusiasm. "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. 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."

About HL7

Founded in 1987, Health Level Seven, Inc. is a not-for-profit, ANSI-Accredited Standards Developing Organization that provides standards for the exchange, management and integration of data that supports clinical patient care and the management, delivery and evaluation of healthcare services. Its 2,200 members represent over 400 corporate members, including 90 percent of the largest information systems vendors serving healthcare. HL7 international affiliates are active in Australia, Canada, Finland, Germany, India, Japan, The Netherlands, New Zealand, Southern Africa and the United Kingdom. HL7's endeavors are sponsored, in part, by the support of its benefactors: Agilent Technologies, Ernst & Young, IDX Systems Corporation, Johnson & Johnson, McKesson HBOC, Quest Diagnostics Inc., Siemens Medical Solutions Health Services Corp., and the U.S. Department of Veterans Affairs. For more information, visit the HL7 web site at http://www.hl7.org/ or contact Karen Van Hentenryck, Associate Executive Director, at Karenvan@HL7.org.

About CDISC

CDISC is an open, multidisciplinary, non-profit organization committed to the development of worldwide industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The CDISC mission is to lead the development of standard, vendor-neutral, platform-independent data models to improve data quality and accelerate product development in the biopharmaceutical industry. It is a CDISC principle to ensure that the data models support the scientific nature of clinical research while improving process efficiency. For more information, visit the CDISC web site at www.cdisc.org or contact Shirley Williams, Director of Operations, CDISC, at swilliams@cdisc.org or Rebecca Kush, Ph.D., President, rkush@cdisc.org.

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