CDISC and HL7 Renew Charter Agreement, Strengthen Relationship.

ANN ARBOR, Mich. & AUSTIN, Texas -- The Clinical Data Interchange Standards Consortium (CDISC) and Health Level Seven (HL7) have agreed to core points for the renewal of an Associate Charter Agreement that was originally signed in March 2001. The new agreement includes reciprocal organizational memberships and reciprocal advisory board positions in addition to educational and financial opportunities and benefits for joint members of both organizations.

"The exchange of CDISC and HL7 advisory board members highlights the importance and necessity of not only the convergence of the standards of these two organizations but also the activities of having CDISC standards referenced in FDA's eCTD Guidance and accrediting clinical research standards through a well-recognized organization such as HL7," said William Qubeck, associate director, electronic submissions data, Pfizer.

While HL7 is focused on standards and interoperability for healthcare systems, the focus of CDISC is on clinical research. The two organizations have found that their activities are becoming increasingly complementary.

"The healthcare industry has hundreds of specialties and as many information stovepipes," said Wes Rishel, past chair, HL7 Board; vice president, research area director, Gartner. "The mission of the HL7 Reference Information Model (RIM) is to break the stove pipes down, or at least make connecting them easy. CDISC brings an important industry segment to the table. Continuing the affiliation is vital to fulfilling our mission."

In January 2004, CDISC made a formal commitment to follow the HL7 Development Framework (HDF). Charlie Mead, MD, a member of the HL7 Board of directors, and director of information architecture at Oracle Corporation and Landen Bain, a director on the CDISC Board and HL7 marketing committee co-chair, are leading this effort. Ultimately, CDISC will provide structured knowledge and information exchange requirements from its clinical research domain expertise. In turn, HL7 will develop ANSI-balloted specifications based upon the Reference Information Model (RIM) and the Version 3 methodology.

"The commitment of CDISC to achieve interoperability with the HL7 standards is an important milestone for the biopharmaceutical industry," said Charles Jaffe, MD, PhD, director, medical informatics, AstraZeneca and a director on the CDISC Board. "It reaffirms the efforts of the regulated research community to become wholly integrated within the continuum of healthcare."

Another goal of the renewed Charter will be the formation of an Outreach Committee for Clinical Research (OCCR). This committee, which will be comprised of members from FDA, CDISC, HL7, NIH and other groups involved in clinical research, will be appointed by the Board of HL7 to strategically represent the domain of clinical research within the context of HL7.

"The agreement between HL7 and CDISC represents an effort by HL7 to reach out to important industry and scientific stakeholders," said HL7 Board Chair Mark Shafarman. "The discussions with CDISC led to the formation of HL7's Outreach Committee for Clinical Research, which will continue this direction."

About CDISC

CDISC is an open, multidisciplinary, non-profit organization committed to the development of worldwide 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 global, vendor-neutral, platform-independent standards to improve data quality and accelerate product development in the pharmaceutical industry. CDISC is made possible through the generous support of its members, sponsors, and volunteer participants. Additional information on CDISC and the CDISC open standards/models can be found on the CDISC website at http://www.cdisc.org.

About HL7

Founded in 1987, Health Level Seven, Inc. (http://www.HL7.org/) is a not-for-profit, ANSI-accredited standards developing organization dedicated to providing a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery and evaluation of health services. HL7's more than 2,000 members represent over 500 corporate members, including 90 percent of the largest information systems vendors serving healthcare.