SDTM DATA CLASSES

Describes the datasets or domains within SDTM. These are of six types as follows

General observation Classes:

Subject level observations collected during the study goes into one of three general observation classes as follows

Special purpose: SDTM includes three types of special purpose datasets

1.  Domain datasets,Demographics(DM),Comments(CO),Subject Elements(SE), Subject Visits(SV),all of which include subject level data that do not conform to one of the three general observation classes
2. Trial Design Model(TDM) datasets-Trial Arms(TA),Trial Elements(TE),Trial Visits(TV) describe the planned design of the study.
3. Relationship datasets-RELREC and SUPPQUAL