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Historically, CDISC standards have primarily been used for regulatory submissions of clinical trials data in support of approval to market medical products. However, recent expansion of CDISC standards through therapeutic area user guide (TAUG) development and an increase in CDISC visibility has led to the recognition of the value of data standards in other areas of medical research as well.
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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