CDISC has published the first of a new kind of QRS supplement to the SDTMIG, a supplement for an oncology response criterion, Response Evaluation Criteria…

The ISO international standard for country codes is ISO-3166, which provides several representations of names for countries (ISO-3166-1) and their subdivisions (ISO-3166-2): Country and Subdivision names…

In an events or interventions domain, the variable –PRESP = "Y" can be used to indicate that the value in the topic variable (–TERM or…

In some cases, the reason for the restriction is fairly obvious, but in other cases, understanding the reason requires understanding the differences between how human…

When an implementer is working how to represent data for a study, they first consult the SDTMIG and SDTM to find the appropriate standard variable….

The earliest version of the SDTMIG had only one domain for tests on biologic specimens taken from a study subject, the Laboratory Test (LB) domain….

If your data is based on a general observation class, you can determine the answer to this question by consulting the SDTM. Qualifiers for your…

In all versions of the SDTMIG through v3.2, the "Conformance" section includes the following as a criterion for conformance: Using SDTM-specified variable labels for all…

Regina Zopf, FDA, Bethesda, MD, USA Jeff Abolafia, Rho, Chapel Hill, NC, USA Bhargava Reddy, UCB, Raleigh, NC USA ABSTRACT There is a lot of…