Use of Fast Healthcare Interoperability Resources (FHIR) in the Generation of Real World Evidence (RWE) demonstrated that electronic CRF data could be populated by mapping FHIR resources to CDASH/SDTM variables. To grow the use of FHIR for eSource beyond pilot projects, existing standards and workflows must be adapted to enable repeatable and scalable processes.
There is a lot of interest in the clinical trial community to understand what information can be obtained from Electronic Health Records (EHRs) to support clinical trials. The use of FHIR has been endorsed by the Office of National Coordinator for Health Information Technology (ONC) and is widely being used by EHR vendors.
"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 the difference? from Medical News Today).
When development of the SDTM and SDTMIG started, SAS was in almost universal use in the pharmaceutical industry and at FDA.
SNOMED (short for SNOMED Clinical Terms or SNOMED CT) is a set of medical terms used widely in clinical practice. Some have asked why CDISC develops its own Controlled Terminology, rather than using SNOMED. There are a number of reasons why we develop terminology:
The terms “domain” and “dataset” are commonly used in CDISC’s nomenclature and found frequently in the Study Data Tabulation Model (SDTM). For example, the SDTM v1.8 includes 134 instances of "domain" and says "A collection of observations on a particular topic is considered a domain." The model includes 78 instances of dataset and certain structures in the model are called "datasets" rather than "domains." Is there a difference between a domain and a dataset?