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Search results with tag "Data tabulation model"
A Guide to the ADaM Basic Data Structure for Dataset …
www.pharmasug.orgFor the purposes of this paper, all data values in Study Data Tabulation Model (SDTM) datasets are considered to be observed. This is despite the fact that in actuality a data value may have been derived prior to or during the creation of the SDTM datasets. For example, an SDTM value of LDL cholesterol derived by the Friedewald calculation from
Metadata Submission Guidelines Appendix to the Study …
clinicalsafetygeek.comData Tabulation Model (SDTM). This Appendix, which is comprised of this document in conjunction with study-related files, identifies and describes the components highly recommended for an electronic submission of SDTM data. The study-related files associated with this appendix include an annotated CRF, representative