Abstract

By Leah van der Meer and Louella Schoemacher 

Whether it is a subject’s parent, an elderly person’s caretaker or a patient’s donor, characteristics of non-subjects, or associated persons, might influence study outcomes. Hence, there is a necessity to process data about associated persons when converting study data to SDTM. CDISC provides an implementation guide for standardising associated persons data into SDTM format.

However, associated persons data is not commonly collected, and the mapping of these data can be challenging: What is the relation with the subject? What is the purpose of mapping these data? Which variables are expected? And what about specific situations such as parent data of twin subjects or a donor with multiple receiving subjects? This paper describes the basics of mapping associated persons data and shows how associated persons domains are different from ‘standard’ domains. It also provides real-life examples of mapping associated persons data into an associated persons domain.

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