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changes.mady.by.user Christine Connolly

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changes.mady.by.user Kathleen Mellars

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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, 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; and

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,

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including studies on tobacco products, collect general information about a subject/participant. This section shows information typically collected in all studies, such as study disposition, demographic and subject characteristic information ( e.g., sex, age), information about prior tobacco product use, safety laboratory tests, and medical history. 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.

Pagenav