Welcome to the CDISC Knowledge Base. The Knowledge Base serves as a resource for finding answers to questions you may have about implementing CDISC standards.
Knowledge Base Terms of Use
This diagram illustrates the steps that go into assessing the causality of an adverse event. For certain kinds of adverse events, some steps are almost automatic (e.g., an infectious disease can...
ADaM datasets include names that start with "AD", therefore "AD" must not be used as the name of a custom SDTM domain. Analysis datasets that are not based on ADaM may have names...
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 measured on a continuous scale; this line...
This is an example for the familiar test Temperature.
A query about adverse events is, at heart, an observation. Data on the adverse event may also include location and pattern. This concept map includes those details, as well as terminology that would...
A substance administration consists of a substance and the activity of administering the substance. Some data items describe the substance, others the administration. ...
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 dataset, one of the new study...
LOINC is a pre-coordinated laboratory coding system used in healthcare IT systems. It includes lab tests, clinical measures, HIPAA documents and standardized survey instruments. It also contains...
Pre-specified Events Collection of adverse event, clinical events, and medical history events can follow two approaches: Were there any events? If yes, what were the events...
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...
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 and Technology (NIST), the...
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 to the same person or animal, but there are...
If data is collected in a log form, and if you know the range of dates or visits for collection of log data then The date or visit at which the log is initiated can be used to populate STTPT...
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...
In ordinary conversation, depending on what “that” is, the question, “When did that happen?” could be answered in many ways. The fact that there are so many ways to say when something happened helps...
