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

Assessing Causality

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...


Standard(s)
SDTM
Proficiency
Novice

Avoiding SDTM and ADaM Dataset and Variable Name Conflicts

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...


Standard(s)
ADaM SDTMIG
Proficiency
Intermediate

Concept Maps for a Finding with Increasing Levels of Detail

This is an example for the familiar test Temperature.


Standard(s)
CDASH SDTM SDTMIG
Proficiency
Intermediate

Concept Maps for Adverse Events with Increasing Levels of Detail

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...


Standard(s)
CDASH SDTM SDTMIG
Proficiency
Intermediate

Concept Maps for Substance Administration with Increasing Levels of Detail

A substance administration consists of a substance and the activity of administering the substance. Some data items describe the substance, others the administration. ...


Standard(s)
CDASH SDTM SDTMIG
Proficiency
Intermediate

LOINC and the SDTM

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...


Standard(s)
Controlled Terminology SDTM SDTMIG
Proficiency
Intermediate

Pre-specified Events and Pre-specified Findings

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...


Standard(s)
CDASH SDTM SDTMIG
Proficiency
Expert

SDTM Structure Diagrams

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...


Standard(s)
SDTM
Proficiency
Novice

Translating CDASH "PRIOR" and "ONGO" to SDTM relative timing variables

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...


Standard(s)
CDASH SDTM SDTMIG
Proficiency
Intermediate

UCUM and CDISC Codelists

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...


Standard(s)
Controlled Terminology SDTMIG
Proficiency
Intermediate

When Did That Happen? A Brief Guide to Representing Timing in SDTM.

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...


Standard(s)
CDASH SDTM
Proficiency
Novice