WORK IN PROGRESS
Disclaimer...
CDISC standards specify how to structure the data to support efficient data sharing for regulated clinical trials.
CDISC standards do not specify what data should be collected or how to conduct clinical trial protocols, assessments, or endpoints.
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User guides do not replace the foundational CDISC standards or their implementation guides. Users should read those standards and implementation guides before applying the advice in user guides.
CDISC data standards are living documents. Due differing update cycles, some of the modeling approaches and controlled terminology presented in the examples in a document may become outdated before the next version of the document is released.
When a particular type of data has existing CDISC standards that can be used without additional development or customization, it is not covered in special detail in subsequent standards.
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A TA standard describes common kinds of data needed for area studies, so that those handling the data (e.g., data managers, statisticians, programmers) understand the data and can apply standards appropriately. These descriptions include the clinical situations from which the data arise, and the reasons these data are relevant for area.
A TA standard strives to define biomedical concepts unambiguously, so that consistent terminology can be used in area studies to enable aggregation and comparison of data across studies and drug programs, and so that metadata for these biomedical concepts can be likewise defined.
References
Clinical guidelines, articles, and other works consulted by the team during the creation of a document are referenced where appropriate. Documents that cite or rely on a large number of references include the full list of references in an appendix labeled "References".
Controlled Terminology
Although the examples in CDISC data standards try to appear plausible, including using controlled terminology where available, they should not be regarded as a definitive source for controlled terminology. Some codelists and/or values applicable to biomedical concepts and data elements in a document may still be in development at the time of publication. Some examples may use values that appear to be controlled terminology, but which are actually generic or "best guess" placeholders. Readers should consult the current CDISC Controlled Terminology (available at the link above) as the ultimate authority for correct controlled terminology codelists and values.
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.