Due to Dataset File Size issue FDA can’t perform the regulatory review on timely manner. The FDA CDER Team conducted internal Quantitative Research on datasets file resize.
The internal research study concluded that significant file size differences exist between both legacy datasets and CDISC datasets, and between different file types used (JMP (.jmp), SAS v7 (.sas7bdat), and Transport v5 (.xpt)).
The have given some recommended action and possible solutions to the sponsors based on their research.
Industries (Sponsor) also involved in this testing through Pharma ERS group.
For more information and download the slides please use the following weblink: FDA CDER Electronic Data Team: SDTM Column Resizing Research - Background and Industry Testing Results
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