• Corpus ID: 61583637

Avoiding a REL-WRECK; Using RELREC Well

@inproceedings{Miller2012AvoidingAR,
  title={Avoiding a REL-WRECK; Using RELREC Well},
  author={Karl Miller and J. J. Hantsch and Janet E. Stuelpner},
  year={2012}
}

• K. Miller, J. J. Hantsch, J. Stuelpner
• Published 2012
• Computer Science

Everything that happens to a single subject in a clinical trial is interrelated. Most points of data can be reported and processed in isolation, but not all. When two or more points of data in two or more CDISC Study Data Tabulation Model (SDTM) domains require reporting their relationship, there is a Special-Purpose domain, RELREC (Related Records) for this purpose. Although employed for accidental (or inexplicit) relationships where data destined for two domains is collected on one CRF page; an explicit relationship between data reported in two domains is also possible. A subject who takes a concomitant medication to treat an adverse event has an explicit relationship between two records in the CM and AE domains. An adverse event which causes a dose-delay or titration (AE & EX), a lab value which indicates a change in dosing epoch (LB & DS) and a substance usage report which results in study termination (SU & DS) are other examples of related records. Careful consideration of what types of explicit relationships are expected and how they will be reported can prevent RELREC from turning into a RELWRECK. In this paper, we demonstrate our method of avoiding the re-mapping of entire SDTM domains and risking mismatched relationships in your final submission data.