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Example

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Medical History Example 1
Medical History Example 1

Tobacco Product Usage  - May use an established published questionaire- may just have a CRF with sponsor questions 

Should  we use SC for all details question about usage and quitting. or FASU....    

Modeling at baseline - question like - longest period of abstinence in the past year 

Have you attempted to quit smoking 

Number of previous attempts to quit smoking  

Used patches  

SU - Used for exposure  amounts.... 

This example illustrates how typical SU data could be populated. Here, the CRF collected:

  • Smoking data
    • Smoking status of "previous", "current", or "never"
    • If a current or past smoker, number of packs per day
    • If a former smoker, the year the subject quit
  •  Current caffeine use
    • What caffeine drinks subjects consumed today
    • How many cups today

SUCAT allows the records to be grouped into smoking-related data and caffeine-related data. In this example, the treatments are prespecified on the CRF page, so SUTRT does not require a standardized SUDECOD equivalent.

Not shown: A subject who never smoked does not have a tobacco record. Alternatively, a row for the subject could have been included with SUOCCUR = "N" and null dosing and timing fields; the interpretation would be the same. A subject who did not drink any caffeinated drinks on the day of the assessment does not have any caffeine records. A subject who never smoked and did not drink caffeinated drinks on the day of the assessment does not appear in the dataset.

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titlesu.xpt
NameSu

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su.xpt

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Row

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STUDYID

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DOMAIN

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USUBJID

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SUSEQ

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SUTRT

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SUCAT

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SUSTAT

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SUREASND

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SUDOSE

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SUDOSU

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SUDOSFRQ

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SUSTDTC

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SUENDTC

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SUSTTPT

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SUSTRTPT

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SUENTPT

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SUENRTPT

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Former Smoker