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Considerations in Creating SDTM Trial Design Datasets
TLDR
This paper will discuss some of the considerations and challenges in creating the TDM datasets, using case studies of both relatively simple and more complex trials, and highlight a number of the pitfalls and misconceptions that are commonly seen when sponsors and their vendors attempt to create theTDM datasets for the first time.
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 submit
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), the
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, the
Considerations in Creating Transparent SDTM-Based Datasets
TLDR
The correct mapping of stored operational data to SDTM-based datasets represents an all-important layer in the overall quest to provide transparent and traceable data.