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Getting Rid of Bloated Data in FDA Submissions
We provide a detailed discussion of 12 high-level rules that apply to folders, transport files, and data sets; we also provide utility programs to help evaluate whether your submission complies with those rules. Expand
Creating Analysis Data Marts from SDTM Warehouses
This paper describes a two-step approach that has been used to build SDTM warehouses and then to extract analysis data marts from them. Expand
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Some Strategies for Validating Your Data before Submission
We describe some special-purpose macros that can be downloaded from SAS that can create both V5 transport files (for clinical trial submissions) as well as V8 and V9 transport files for non-submission purposes. Expand