What information does SDTM.DM (Demographics) contain?
This post is part of 'SDTM | Demographics' series
- DM (Demographics) domain of SDTM belongs to special purpose domains
- SDTM broadly classifies the data collected in a clinical trial into three general observation classes
- Some data collected does not fit into any of the above three observation classes and so, we have this separate classification called 'special purpose domains'
- DM domain contains below sets of standard variables that describe each subject in a clinical study
- study reference start and end dates for each subject
- treatment start and end dates
- date of informed consent and date of end of participation
- birth and death dates
- site and investigator identification details
- variables that may affect the drug activity
- the planned and actual treatments