"Sex" and "gender" are similar but different concepts whose definitions and meanings can be confusing (see, for example, the article Sex and gender: What is…

Sam Hume, CDISC, State College, PA, USA Jeff Abolafia, Rho, Chapel Hill, NC, USA Geoff Low, Medidata Solutions, London, UK   ABSTRACT Use of Fast…

PHUSE US Connect 2019 Priya Gopal, TESARO, Waltham, MA, USA Jeff Abolafia, Rho, Chapel Hill, NC, USA Sam Hume, CDISC, State College, PA, USA  …

The International System of Units (SI), commonly known as the metric system, is the international standard for measurement. According to the National Institute of Science…

In the diagrams below, the red line represents a graph of severity over time for a hypothetical event. For most adverse events, severity cannot be…

For an implementer trying to decide where data belong in SDTM-based datasets, it's pretty clear when data belongs in a trial design dataset, a relationship…

1. Who makes Controlled Terminology? You do! Controlled Terminology is developed from user requests, as well as requests from the CDISC Foundational and Therapeutic Area…

The BRIDG model makes a distinction between a study subject and an experimental unit.  In most studies for which SDTM is implemented, these terms refer…

If you're trying to figure out how to represent imaging data in SDTM, it may be helpful to think about the similarities between an image…

A Summary of the Project The Japan Agency for Medical Research and Development (AMED) was established in 2015 for the advancement of medical discoveries that…