Medical History

For study subjects, medical conditions are represented as events in the Medical History (MH) domain.

This MH domain is 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 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 DM domain) and no later than the start date of the 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 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.

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.

Row 1:	Subject 1234005 is a 2-pack/day current smoker. “Current” implies that smoking started sometime before the time the question was asked (SUSTTPT = "2006-01-01", SUSTRTPT = "BEFORE") and had not ended as of that date (SUENTTP = "2006-01-01", SUENRTPT = "ONGOING"). See Section 4.4.7, Use of Relative Timing Variables for the use of these variables. Both the beginning and ending reference time points for this question are the date of the assessment.
Row 2:	Subject 1234005 drank 3 cups of coffee on the day of the assessment.
Row 3:	Subject 1234006 is a former smoker. The date this subject began smoking is unknown, but it was sometime before the assessment date; this is shown by the values of SUSTTPT and SUSTRTPT. The end date of smoking was collected, so SUENTPT and SUENRTPT are not populated. Instead, the end date is in SUENDTC.
Row 4:	Subject 1234006 drank tea on the day of the assessment.
Row 5:	Subject 1234006 drank coffee on the day of the assessment.
Row 6:	Subject 1234007 had missing data for the smoking questions; this is indicated by SUSTAT = "NOT DONE". The reason is in SUREASND.
Row 7:	Subject 1234007 also had missing data for all of the caffeine questions.

su.xpt

Row	STUDYID	DOMAIN	USUBJID	SUSEQ	SUTRT	SUCAT	SUSTAT	SUREASND	SUDOSE	SUDOSU	SUDOSFRQ	SUSTDTC	SUENDTC	SUSTTPT	SUSTRTPT	SUENTPT	SUENRTPT
1	1234	SU	1234005	1	CIGARETTES	TOBACCO			2	PACK	QD			2006-01-01	BEFORE	2006-01-01	ONGOING
2	1234	SU	1234005	2	COFFEE	CAFFEINE			3	CUP	QD	2006-01-01	2006-01-01
3	1234	SU	1234006	1	CIGARETTES	TOBACCO			1	PACK	QD		2003	2006-03-15	BEFORE
4	1234	SU	1234006	2	TEA	CAFFEINE			1	CUP	QD	2006-03-15	2006-03-15
5	1234	SU	1234006	3	COFFEE	CAFFEINE			2	CUP	QD	2006-03-15	2006-03-15
6	1234	SU	1234007	1	CIGARETTES	TOBACCO	NOT DONE	Subject left office before CRF was completed
7	1234	SU	1234007	2	CAFFEINE	CAFFEINE	NOT DONE	Subject left office before CRF was completed

Former Smoker

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Medical History