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Pilot Project Submission Package

The CDISC SDTM/ADaM Pilot Project package that was submitted to the FDA in February 2007 is available to CDISC members for use as an example of the application of the CDISC standards. (Refer to the project report for the list of CDISC standards used.)  Included in the package are the cover letter, the reviewer’s guide, the protocol, the statistical analysis plan, the blank CRF (annotated), the abbreviated study report, the tabulation (SDTM) datasets, and the analysis datasets. The SDTM dataset metadata, the analysis dataset metadata, and the analysis results metadata are provided in a Define.XML file.

It should be noted that two versions of the Define file are included - a framed and a no-frame version.  The framed version works only with Internet Explorer, but offers much superior navigation capabilities. The non-framed version can be used with browsers other than Internet Explorer, but can be difficult to navigate with Internet Explorer 6.

 

CDISC SDTM/ADaM Pilot Project Submission Package