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911 articles found
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Pre-specified Events and Pre-specified FindingsPre-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? Did event X occur?If yes,... -
Avoiding SDTM and ADaM Dataset and Variable Name ConflictsDataset names 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 that st...
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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 t...
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Translating CDASH "PRIOR" and "ONGO" to SDTM relative timing variablesIf 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...
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Concept Maps for a Finding with Increasing Levels of DetailThis is an example for the familiar test Temperature. At the simplest level, we have a test with a result performed on a particular date/time. A medical record might include more information, such as...
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Concept Maps for Substance Administration with Increasing Levels of DetailA substance administration consists of a substance and the activity of administering the substance. Some data items describe the substance, others the administration. In some situations, there is a...
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Concept Maps for Adverse Events with Increasing Levels of DetailA 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 Controlled Terminology...
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LOINC and the SDTMLOINC 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 ter...
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SDTM Structure DiagramsSDTM describes several types of datasets. This diagram illustrates a hierarchical view of those types of datasets. Findings domains may be represented as findings about a study subject or about an ass...
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UCUM and CDISC CodelistsUnified 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 u...