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Tolerance Test 2 Summary is here.

Knowledge Base

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.

Controlled Terminology, SDTMIG
Intermediate
Knowledge Base
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 terms for human clinical research but its scope goes beyond research use. LOINC is used in over 170 countries and is mandated in 30.
Controlled Terminology, SDTM, SDTMIG
Intermediate
Knowledge Base

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.

SDTM
Novice
Knowledge Base
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 be used in SDTM.
CDASH, SDTM, SDTMIG
Intermediate
Knowledge Base
A substance administration consists of a substance and the activity of administering the substance. Some data items describe the substance, others the administration.
CDASH, SDTM, SDTMIG
Intermediate
Knowledge Base
This is an example for the familiar test Temperature.
CDASH, SDTM, SDTMIG
Intermediate
Knowledge Base
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 and CDASH PRIOR or ONGO can be used to populate STRTPT, The date or visit at which the log is finalized can be used to populate ENTPT and CDASH PRIOR or ONGO can be used to populate ENRTPT. STRF and ENRF are not needed and should not be used.
CDASH, SDTM, SDTMIG
Intermediate
Knowledge Base
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 to explain why there are so many timing variables in SDTM.
CDASH, SDTM
Novice