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This section provides advice and examples for collecting and representing data in human clinical trials where the interest is evaluating tobacco product using the Clinical Data Acquisition Standards Harmonization (CDASH) model, and the Study Data Tabulation Model (SDTM), including
guidance on the use of domains and variables;
sample annotated case report forms (aCRFs);
- examples of SDTM datasets, with text describing the situational context and pointing out records of note.
The primary focus will be illustrating concept specifically related to clinical trials using tobacco products. Advice and examples for topics that are essentially the same as for Human Clinical trials, can be found in ...
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All studies All studies,
including studies on tobacco products, collect general information about a subject/participant. The following This section shows data information typically collected in tobacco product studies. This includes all studies, such as study disposition, demographic and subject characteristic information ( e.g., Sexsex, Ageage), information about prior tobacco product usage. use, safety laboratory tests, and medical history. ( NOTE-LIST to be revised to fix domains included in this section ) Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-160
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Most subject-level observations collected during the study should be represented according to 1 of the 3 SDTM general observation classes: Interventions, Events, or Findings.
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