We have compiled a number of frequently asked questions to answer your inquiries about Controlled Terminology.
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 and a specimen.
A sample taken from a subject for testing at a lab is a surrogate for the subject. Results of tests on the specimen tell us something about the subject at the time the specimen was taken.
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 make life better for everyone. Working under the Prime Minister’s Cabinet and national ministries, AMED provides a single avenue for researchers and institutions seeking funding for medical research and development.
The SDTMIG directs that, under certain circumstances, variables can be populated with the values "MULTIPLE" or "OTHER". Neither of these values is what might be called a "proper" value for the variable (i.e., a value that provides the the kind of information intended to be represented in the variable). Instead, these special values indicate that there are either multiple proper values or that the proper value collected was not in the list of values presented on the data collection form.
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?
When development of the SDTM and SDTMIG started, SAS was in almost universal use in the pharmaceutical industry and at FDA.
"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).
Unified Code for Units of Measure (UCUM) was developed by Regenstrief Institute and the UCUM Organization as an unambiguous system of units and their combinations. UCUM is intended to include all units of measure currently used internationally in science, engineering and business and has been adopted internationally by IEEE, DICOM, LOINC, and HL7, and is also in the ISO 11240:2012 standard.
SDTM describes several types of datasets. This diagram illustrates hierarchical view of these types of datasets. Findings may be findings about a study subject or about an associated person. A finding record can be linked to supplemental qualifiers, to comments, or to other records via relationships represented in RELREC.