Subject Elements (SE) :

DEFINITION : The Subject Elements (SE) domain captures the different phases (elements) that a subject goes through during the trial, such as screening, treatment, and follow-up.

PURPOSE : To document the timing and sequence of trial elements for each subject, allowing precise tracking of their progression through different study phases.

STRUCTURE : One record per actual Element per subject

TOPIC : ETCD

KEY VARIABLES : STUDYID, USUBJID, ETCD, SESTDTC