Article
The SDTMIG’s description of time point variables covers two different use cases:
1. A planned set of findings scheduled relative to a reference time point, usually a dose of study treatment.
2. A planned number of repeated measurements.
Standard(s)CDASH, Questionnaires, Ratings and Scales (QRS), SDTM, SDTMIG
Article
CDASH and SDTM are each optimized for different purposes, and the philosophy behind each drives the design. SDTM represents cleaned, final CRF data organized in a predictable format that facilitates data transmission, review and reuse. CDASH collects the data in a user-friendly, EDC/CRF-friendly way that maximizes data quality and flows smoothly into SDTM.
Standard(s)CDASH, CDISC Controlled Terminology, Medical Devices, SDTM, SDTMIG