WORK IN PROGRESS
Concept Maps
CDISC often uses concept maps to explain clinical processes and biomedical concepts. Concept maps, also sometimes called mind maps, are diagrams which include “bubbles” representing concepts/ideas/things and labeled arrows that represent the relationships between the concepts/ideas/things. They are generally easier to draw and more accessible than more formal modeling diagrams, such as Unified Modeling Language (UML) diagrams.
The diagrams in CDISC standards use the following coding for classification of concepts:
This classification is based on classes in the Biomedical Research Integrated Domain Group (BRIDG) model (available at http://bridgmodel.nci.nih.gov/). These color-symbol pairs have been used to highlight kinds of things that occur commonly in clinical data and therefore give rise to common patterns of data. Some concepts are not coded; they have a thinner, black outline, and no accompanying symbol. These may include the subject of an observation, as well as characteristics, or attributes, of the coded concepts.
What is a "TAUG"?
“TAUG” stands for “therapeutic area user guide”, an informative data standard that focuses on a specific therapeutic area. "TAUG" is the prefix used in the short name for all such documents; in conversation, they are usually called "TA standards", TA user guides", or "TA guides".
What is CFAST?
What is a "biomedical concept"?
A biomedical concept (BC) is a unit of knowledge, created by a unique combination of the characteristics that define observations of real world phenomena in clinical research and/or healthcare, which represents biomedical knowledge that borrows from medical knowledge, statistical knowledge, BRIDG, and the CDISC standards. Metadata for biomedical concepts include the properties of the data items that are parts of the concepts, controlled terminology for those data items, and the ways in which the concepts relate to each other.