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The basic difficulty in transforming CRF observations to CDISC SDTM tables comes from the different data structures.
To achieve this, we developed SDTM mapping rules, which are consisted of SDTM attributes to ISO/IEC 11179 basic attributes.
Included in the current release of the "Toolkit" is a standard Study Outline Template in MS Word format, a standard list of Study Outline Concepts and a complete mapping of the Study Outline Concepts to both the Biomedical Research Integrated Domain Group (BRIDG) model and the CDISC Study Data Tabulation Model (SDTM) Trial Summary (TS) Domain.
Use of the CDISC SDTM and Define.xml submission standards, for example, are specified in the FDA's current guidance for submissions using the electronic Common Technical Document (eCTD).
Another important CDISC standard is the Study Data Tabulation Model (SDTM), a standardized representation for clinical trials observations using a set of standard data variable names and table structures.
Genzyme has implemented or is in the process of implementing CDISC standards end-to-end, including PROTOCOL, CDASH, LAB, SDTM, ADaM and Controlled Terminology as well as utilizing BRIDG as its underlying information model.
* be able to check CRF, Central Lab, SDTM, ADaM data and define.xml file against CDISC standards and Genzyme-specific requirements to ensure that Genzyme receives, produces and submits quality data.
"Two key areas of emphasis from a process standpoint include the use of standard libraries, especially CDISC (in particular SDTM and ODM with BRIDG and/or CDASH), and remote site management or monitoring.
A CRO with its own technology, compared to a pure software company, will know how to create 100% accurate data sets in FDA-acceptable SDTM format.
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