Considerations in Submitting Non-Standard Variables: Supplemental Qualifiers, Findings About, or a Custom Findings Domain
@inproceedings{Salyers2015ConsiderationsIS, title={Considerations in Submitting Non-Standard Variables: Supplemental Qualifiers, Findings About, or a Custom Findings Domain}, author={Jerry Salyers and Richard Lewis}, year={2015} }
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 Implementation Guide (SDTMIG) provides for a standard mechanism and structure for submitting non-standard variables. That paper discussed common issues seen when submitting SUPP-- datasets, from using an inappropriate IDVAR to the practice of submitting data “as collected” (i.e. “coded”) though… CONTINUE READING