In SDTMIG v3.4 and SDTM v2.0, formats for Date/Time variables are now specified as "ISO 8601 datetime or interval." You may ask “What's that interval…

CDISC employs a rigorous approach to developing data standards. Each standard is informed and shaped by experts, making them not just of the highest quality,…

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…

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,…

This diagram illustrates the steps that go into assessing the causality of an adverse event.  For certain kinds of adverse events, some steps are almost…

Dataset names ADaM datasets include names that start with "AD", therefore "AD" must not be used as the name of a custom SDTM domain. Analysis…

Pre-specified Events Collection of adverse event, clinical events, and medical history events can follow two approaches: Were there any events? If yes, what were the…

In ordinary conversation, depending on what “that” is, the question, “When did that happen?” could be answered in many ways. The fact that there are…

If data is collected in a log form, and If you know the range of dates or visits for collection of log data then The…

This is an example for the familiar test Temperature. At the simplest level, we have a test with a result performed on a particular date/time….