2 min readJun 9, 2021
Background:
Last time we went over TA, Today we will go over Trial Element dataset. The trial Element domain contains all the info regarding the Elements included in the study, therefore the administration of planned trials uses Element as the basic building block to describe the time periods without any gaps.(Screening, Treatment, Followup). Each planned Element will have corresponding beginning and ending rules.
Key Variables:
ETCD: Code value assigned to ELEMENT.
*TA dataset should be consist with TEELEMENT: indicates the assigned treatment
*TA dataset should be consist with TE, otherwise replace with "UNPLAN"TESTRL: identifies the event that marks the transition into this Element.*Clear definition to washout the previous drug effectTEENRL: describes conditions how subject move out or completed the assigned Element.
*ex:15 days after start of ElementTEDUR: populates in ISO 8601 format when TEENRL is populated.
*ex: P6W = 6 weeks after start of elementP21D= 21 days after start of element
Sample Spec:
Sample Output:
Sample Trial Element Dataset