Clinical Data Interchange Standards Consortium (CDISC)
The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit group that defines clinical data standards for the pharmaceutical industry. CDISC has developed numerous data models that you should familiarize yourself with. Four of these models are of particular importance:
Study Data Tabulation Model (SDTM).
The SDTM defines the data tabulation data sets that are to be sent to the FDA as part of a regulatory submission. The FDA has endorsed the SDTM in its Electronic Common Technical Document (eCTD) guidance. The SDTM was originally designed to simplify the production of case report tabulations (CRTs), and therefore the SDTM is listingfriendly, but not necessarily friendly for creating statistical summaries and analysis.
Analysis Dataset Models (ADaM).
The CDISC ADaM team defines data set definition guidance for the analysis data structures. These data sets are designed for creating statistical summaries and analysis.
Operational Data Model (ODM).
The ODM is a powerful XML-based data model that allows for XML-based transmission of any data involved in the conduct of clinical trials. SAS has provided support for importing and exporting ODM files via the CDISC procedure and the XML LIBNAME engine.
Case Report Tabulation Data Definition Specification (Define.xml).
Define.xml is the upcoming replacement for the data definition file (define.pdf) sent to the FDA with electronic submissions. Define.xml is based on the CDISC ODM model and is intended to provide a machine-readable version of define.pdf. Because define.xml is machine readable, the metadata about the submission data sets can be easily read by computer applications. This allows the FDA to work more easily with the data submitted to it.
You will be exporting, importing, and creating data for these models, so it is important that you learn about them. The FDA has formally endorsed the use of these data models in their guidance. Eventually the FDA will probably require data to be formatted to the CDISC model standards for regulatory submissions.