What information does SDTM.PR (Procedures) contain?
This post is part of 'SDTM | Procedures' series
- PR domain of SDTM belongs to interventions observation class
- Interventions observation class is designed to capture the investigational, therapeutic, and other treatments that are administered to the subject
- PR domains captures interventional activity intended to have diagnostic, preventive, therapeutic, or palliative effects
- Some interventions that get classified as 'procedures' are
- Disease screening (mammogram, pap smear)
- Endoscopic examinations (laparoscopy, colonoscopy etc)
- Diagnostic tests (X-RAY, CT scan, MRI scan, biopsy, catheterization etc)
- Therapeutic procedures (radiotherapy, phototherapy, mechanical ventilation etc)
- Surgical procedures
- This domain is intended only to capture the occurrence of the procedure and all the measurements collected from the procedure are collected in a relevant findings domain
- When only findings from a procedure are collected in a study (and information related to timing or occurrence of procedure is not collcted), then findings domain is sufficient and method of examination can be captured in --METHOD variable of the findings domain