TE: SDTM Trial Element Dataset

Background:

Last time we went over TA , Today we will go over Trial Element dataset. Trial Element domain contains all the info regarding the Elements included in the study, therefore administration of planned trials use Element as the basic building block to describe the time periods without any gaps.(Screening, Treatment, Followup). Each planned Element will have a corresponding beginning and ending rules.

Key Variables:

ETCD: Code value assigned to ELEMENT.
*TA dataset should be consist with TE

ELEMENT: 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 effect

TEENRL: describes conditions how subject move out or completed the assigned Element.
*ex:15 days after start of Element

TEDUR: populates in ISO 8601 format when TEENRL is populated.
*ex: P6W = 6 weeks after start of element
     P21D= 21 days after start of element

 

Sample Spec:

 

Sample Output:

Sample Trial Element Dataset

 

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