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- W2186810367 abstract "Everyone making clinical trial submissions tries for the process to go as smoothly as possible, but there are some places where missteps can cause delays. Avoiding these missteps can greatly streamline the submission review process. The CDISC SDTM Implementation Guides have hundreds of pages that provide exhaustive (and exhausting) detail about dozens of domains and their variables, but those Implementation Guides don’t provide any information about how long any of the variables should be. Careful data design and some utility processes can take the guesswork out of assigning lengths to character variables in submission data sets.. V5 transport files are the approved mechanism for transmitting clinical trial data within a submission. The usual way for creating them is with PROC COPY and the XPORT Libname Engine. But now there are 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). The define.xml contains information about what a reviewer can expect to find in a submission. Because discrepancies between the define.xml and the submission data sets can cause delays in the FDA review, it is very important to make sure that the define.xml truly reflects the submission data’s metadata. The SAS Clinical Standards Toolkit (CST) provides a way to reconcile the define.xml with submission data metadata so that any discrepancies can be resolved before a submission is made." @default.
- W2186810367 created "2016-06-24" @default.
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- W2186810367 date "2013-01-01" @default.
- W2186810367 modified "2023-09-27" @default.
- W2186810367 title "Some Strategies for Validating Your Data before Submission" @default.
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