The CDISC Study Data Tabulation Model (SDTM):
History, Perspective, and Basics
Principal Consultant, Octagon Research Solutions
The CDISC (Clinical Data Interchange Standards Consortium) SDTM is a standard for submitting data tabulations to the FDA
in support of marketing applications. In July of 2004, this standard became a Study Data Specification (1) referenced in the
eCTD Guidance (2). The FDA has announced on several occasions their intention to make the SDTM required by regulation
(3-6). This paper/presentation will focus on the SDTM and the SDTMIG (SDTM Implementation Guide: Human Clinical Trials),
but will also describe the regulatory climate around the SDTM, and provide an update on recent activities with SEND
(Standard for Exchange of Nonclinical Data), an implementation of the SDTM for animal toxicology and pharmacology studies.
NOTE TO READERS
In an attempt to make wading through the alphabet soup of acronyms, some of the more frequently used ones are
listed at the end of this paper.
From its inception in 1997, CDISC has recognized the need for the establishment of standard data models to improve the
process of electronic acquisition and exchange of clinical trials information for the benefit of all medical and pharmaceutical
stakeholders. This is reflected in the mission statement:
"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 mission of CDISC is to develop and support global, platform-independent data
standards that enable information system interoperability to improve medical research and related areas of healthcare."
While the focus of this paper is the SDTM (developed by the CDISC Submission Data Standards [SDS] Team), it is im