CDISC Releases New Submissions Domain Models

Austin, TX - 27 November 2001 -The Clinical Data Interchange Standards Consortium (CDISC) announced the publication of Version 2.0 of the CDISC Submissions Domain Models. These new models were developed by the Submissions Data Standards (SDS) team, which includes more than 20 active members representing major pharmaceutical companies and contract research organizations (CROs).

"To see a set of standards be developed to this level by representatives of companies that have different ways of doing things is truly remarkable," said Fred Wood, Procter & Gamble Pharmaceuticals. The Version 2.0 domains were also developed with active participation of the FDA liaisons to CDISC, and have been tested with standard computer applications that are being used within the FDA.

"The Version 2.0 SDS domains have been designed for broad adoption throughout the industry," said SDS Team Leader, Wayne Kubick. "We believe these models have addressed most of the ambiguities and concerns that were raised by early adopters of Version 1.0, and will serve as a solid foundation for our future submission modeling efforts." It is important to CDISC that their modeling efforts support worldwide standards.

"CDISC espouses the cause of developing global standards -- a challenge we willingly face. This is a logical step after having implemented standards in our local environment," said Dr. Johann Bruening, Head of Global Standards for Clinical Data, Schering AG.

Among the many improvements in the SDS Version 2.0 domains are revisions to the core and non-core variable contents, definitions and names, the addition of standard formats and decodes [including support for the Logical Observation Identifier Names and Codes (LOINC) database maintained by the Regenstrief Institute], compatibility with the ICH E2B standard for adverse event reporting, an improved presentation format, and expanded documentation. Version 2.0 also includes two new alternative vertical representations of Vital Signs and ECG data, in addition to the horizontal representations originally prepared for the Version 1.0 models.

"We believe the vertical representations will be increasingly useful as the FDA moves to standard database applications for data review and analysis, while the horizontal representations are more historically suited to working with flat data files," said Chris Tolk of Bayer Corporation, Pharmaceutical Division.

"Covance believes that submission data modeling is essential to improving communication of clinical trial data between pharma companies, CROs and regulatory authorities," said Michael Walega, who represents Covance on the CDISC Industry Advisory Board. "We continue to actively support the SDS team in its efforts to develop these improved models."

As a related CDISC activity, their Analysis Dataset Modeling team (ADaM) recently published a draft set of guidelines for the submission of analysis datasets and documentation and a strawman metadata model for a percent change from baseline statistical analysis. Both documents are posted on the CDISC website and are currently undergoing review and testing by FDA statisticians.

CDISC encourages adoption of these models both for regulatory submissions and for use within sponsor organizations. CDISC requests feedback from industry on the SDS and ADaM models through its website discussion facility. The industry feedback will be used to improve future versions of the models. The SDS group is also working on additional domain models for pharmacokinetics data and other safety and efficacy domains.

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.

Additional information, including downloadable copies of the Version 2.0 SDS models, can be found on the CDISC website at www.cdisc.org.

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