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Considerations in Creating SDTM Trial Design Datasets
TLDR
Many sponsors are now submitting clinical trials data to the FDA in the format of the CDISC SDTM. Expand
Considerations in the Submission of Exposure Data in SDTM-Based Datasets
The submission of data regarding the subjects’ exposure to a study treatment is critical in assessing its safety and efficacy. While more and more sponsors are committing resources to submitExpand
Considerations in Submitting Non-Standard Variables: Supplemental Qualifiers, Findings About, or a Custom Findings Domain
As discussed by one of the authors in 2013 (Wood. F, Considerations in Data Modeling when Creating Supplemental Qualifiers Datasets in SDTM-Based Submissions, PharmaSUG Proceedings, May 2013), theExpand
SDTM EX and EC : Considerations When Submitting Exposure Data
Per the SDTMIG v3.2, the Exposure (EX) domain should contain only unblinded data for study treatment that was administered to subjects presented in protocol-specified units. Because of this, theExpand
Considerations in Creating Transparent SDTM-Based Datasets
TLDR
This paper will focus on several examples of how transparency at the data level may be compromised by poor or misleading mapping of operational data to SDTM-based datasets. Expand