Toward a Comprehensive CDISC Submission Data Standard
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Toward a Comprehensive CDISC Submission Data Standard Wayne R. Krbick, MIA Phase Forward. Inc., Waltham, Massachusetts Stephen Rrberg, PhD Global Medical Information Sciences. Medical Research S.Development Eli Lilly and Company, Indianapolis, Indiana
Edward Helton, PhD Pharmaceutical & Regulatory Science, SAS Institute, Cary, North Carolina
Key Words Clinical data standards; CDISC; eCTD; In teroperability; Analysis; Metadata; Submission Correspondence Address Wayne Kubick, Phase Fonvard/Lincoln Technologies. 880 Winter Street, Waltham, M A 02154 (e-mail: wayne.bbick@ lincolntechnologies.corn).
This article proposes a comprehensive set of data standards to address the submission of clinical data based on the work of the Clinical Data Interchange Standards Consortium (CDlSC). The present components of the CDISCsubmission standards are described and related to Food and Drug Administration guidelines on submission as expressed in the 1999 guidance documents on regulatory submissions and the 2005 guidance on the electronic Common Technical Document (eCTD). The relative
BACKGROUND A N D OBJECTIVES OF T H E C D I S C S U B M I S S I O N DATA STANDARDS The Clinical Data Interchange Standards Consortium (CDISC) began in 1997 as a grassroots effort among individuals with a common interest in developing standards for clinical data. Early CDISC efforts included the creation of a glossary of clinical research terms, an essential building block for semantic interoperability, and the discussion of different approaches toward creating clinical data standards. During this time, it was difficult to identify a common ground between the different parties that would serve as the basis for developing a common standard. In 1999, leading CDlSC participants proposed concentrating their standards development efforts in two distinct areas: a vendor-independent standard for exchanging information between separate clinical data management systems, which later became known as the CDISC Operational Data Model, or ODM, and a standardized approach for preparing data submissions to the Food and Drug Administration (FDA), which became known as the CDISC submission data standards (SDS). There were several reasons for proceeding along these parallel paths. First, exchanging data between disparate systems was largely a techni-
rdes of the CDlSC Study Data Tabulation Model (SDTM); the Case Report Tabulation Data Description Specification (define.xml), which is based on the CDlSC Operational Data Model (ODM); and the Analysis Dataset Models (ADaM) in meetingsubmission data requirements are next described. Finally, this article discusses implementation alternativesfor sponsors, fiture directions, and the potential benefit of current projects to improve the submission process.
cal problem, best solved by softwaredevelopment experts with knowledge of clinical data systems in the regulated clinical research environment. Because the requirements for this activity involved defining a common approach that would work with both rapidly advancing elect
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