Study data in CDISC?
The Study Data Tabulation Model (SDTM) of the Clinical Data Interchange Standards Consortium (CDISC) represents the future standard for the export of clinical data.
Also recognized by the FDA, a standard like this allows to subject data from different studies in a simple way to a meta-analysis. CDISC data export is already a requirement of many of our customers. However, only few know what kind of effort is necessary to prepare and process the data. Thus, the sponsors requirements (annotated CRF, metadata and code lists) must be checked for SDTM compliance, furthermore based on the CRF a mapping must be created and implemented. And of course, these processes are subject to an internal validation again.
Supported by cccp (www.3cp.biz) Alcedis has already built up an extensive expertise and conducts CDISC-compliant data exports on demand.