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SDTM Model is build around the concept of observations which are the small pieces of message collected during the study. Observation is nothing it is the row dataset and variables are the column dataset, also observations are reported in a series of domain also domain is two-name characters. Mostly observations are collected during study and fit into some observation class


2.Event dataset

3. Finding

1.Interventions dataset

It captures treatment and procedure that are given to the subject as specified protocol.

Example-  EX (exposure)

                 CM (concomitant medications)

                 SU (substance used


Event capture planned protocol also include unplanned incident that occur before or during study are captured.

Example   -Adverse Effect (AE)

Disposition (DS)

Medical History (MH)


Finding capture observations that address specific question such as observations made during physical examination/screening the volunteer


VS  Vital sign

PE  Physical exam

LB—- labs

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