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For study subjects, medical conditions are represented as events in the Medical History (MH) domain. This MH domain is is an Events domain used to represent information collected about medical conditions that started prior to the start of the study. The study timepoint at which events stop being pre-study events (medical history) is determined by the sponsor applicant according to the requirements of the study. However, the "stop" timepoint may be no earlier than the date of informed consent (which is recorded for each subject in the RFICDTC variable in the Demographics (DM) domain) and no later than the start date of the Study Reference Period study reference period (which is recorded for each subject in the RFSTDTC variable in the DM dataset). The timepoint is usually identifiable as the point at which medical history information is collected; medical conditions starting after the collection of medical history information are often considered to be on-study events. Note that the : The relative timing variables used to represent medical history events as being "prior" or "ongoing" will depend on whether the collection of medical history information coincides with the start of the study reference period.
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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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| title | su.xpt |
|---|---|
| Name | Su |
...
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Pagenav
su.xpt
...
Row
...
STUDYID
...
DOMAIN
...
USUBJID
...
SUSEQ
...
SUTRT
...
SUCAT
...
SUSTAT
...
SUREASND
...
SUDOSE
...
SUDOSU
...
SUDOSFRQ
...
SUSTDTC
...
SUENDTC
...
SUSTTPT
...
SUSTRTPT
...
SUENTPT
...
SUENRTPT
...
Former Smoker
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