CDISC RELEASES NEW SUBMISSIONS DOMAIN MODELS

Open for public review and comment

AUSTIN, Texas – 2 April 2003 - The Clinical Data Interchange Standards Consortium (CDISC) announces the first release of the Version 3.0 Submission Data Domain Models. These new models were developed by the CDISC Submissions Data Standards (SDS) Team, which includes more than 20 active members representing major pharmaceutical companies, contract research organizations (CROs), and FDA liaisons to CDISC.
Version 3.0 (V3) has been released by CDISC for open, public comment and has simultaneously been submitted for ballot approval as a Health Level 7 (HL7) informative document. Comments will be accepted until close of business on Wednesday, 23 April 2003. Comments can be submitted either through the CDISC Discussion Board at http://www.cdisc.org/discussions/discussions.html or via the HL7 ballot process (http://www.hl7.org).

The results of the Version 2.0 SDS pilot and the feedback from internal FDA reviews were the driving forces behind the changes that have led to Version 3.0. The V3 general models are intended to accommodate all clinical trial data.

“This is the big one,” said Wayne Kubick, CDISC Technical Director. “We’ve adapted V3 to address the changes the FDA wanted. We expect this version to be referenced by FDA Guidance documents this year, and believe it is the one that will be adopted throughout the industry.”

In a recent letter from the FDA to the CDISC SDS team, Janet Woodcock, Director, Center for Drug Evaluation and Research, and Randy Levin, Associated Director for Information Management for the Center, write, “Congratulations on the publication of the Clinical Trial Data Regulatory Submission Model at HL7! We feel that the model represents a significant advance for improving the efficiency of both the FDA and industry for bringing safe and effective treatments to the public.”
“While the Version 2.0 models were designed to make datasets more readily analyzable, the Version 3.0 models were designed primarily to facilitate the storage of all case report tabulation (CRT) datasets in a central data repository,” said Fred Wood, Procter & Gamble Pharmaceuticals. “Despite this difference, the Version 3.0 models used the ten original safety domains of the Version 2.0 Models as a base, so there are many similarities as well.”

“We learned a lot with Version 2.0 and we’ve applied those learnings to create the current SDS models, ” stated Mary Lenzen and Bill Qubeck, Pfizer, PGRD. “The new approach (V3.0) provides a framework by which the industry no longer has to guess what the agency wants. For the first time our primary customer of clinical data, the FDA, has been with us every step of the way. Version 3.0 improves upon V2.0 and is another giant step forward in delivering what the agency needs for an efficient and quality review.”

Among the changes in the SDS Version 3.0 domains are: the incorporation of a new general study data information model intended for use with most types of clinical data; the introduction of date/time variables with a precision indicator; the introduction of new variables and domains; and several changes to variable names, labels, controlled terminology and descriptions.

According to Michael Walega of Covance, "The Version 3.0 SDS models are a logical extension of the Version 2.0 models. They offer the benefit of reduced maintenance effort, logical grouping of similar clinical trials data, and enhanced ability to effectively warehouse submissions data."

In addition to the HL7 ballot on the SDS Version 3.0, there will be a ballot on the CDISC LAB model for its approval through the HL7 standards accreditation process. The CDISC LAB model, which was posted as a production version in October 2002, is designed to facilitate the exchange of clinical laboratory data from central laboratories to clinical trial sponsors, CROs and technology/EDC providers. The CDISC LAB model can be implemented via SAS, ASCII or an XML schema. An HL7 implementation of the LAB model has been pursued for those companies who utilize HL7 messaging. On approval, the HL7 clinical trial laboratory message will be an ANSI-approved standard.

“The experience of HL7 in the development and maintenance of standards has enhanced both the CDISC and HL7 versions of the LAB model. We believe that approval through HL7 and ANSI accreditation will augment the utility of this model,” said Susan Bassion, leader of the CDISC LAB Team.

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.

###

For more company information contact:
Shirley Williams, Director of Finance/Operations, CDISC, 512-341-9885, swilliams@cdisc.org, http://www.cdisc.org

Rebecca Kush, Ph.D., President, CDISC, rkush@cdisc.org