Subject Visits (SV)

Subject Visits (SV) is a special purpose domain that contains information for each subject's actual and planned visits.

The Subject Visits domain consolidates information about the timing of subject visits that is otherwise spread over domains that include the visit variables (VISITNUM and possibly VISIT and/or VISITDY). Unless the beginning and end of each visit is collected, populating the SV dataset will involve derivations. In a simple case where for each subject visit exactly 1 date appears in every such domain, the SV dataset can be created easily by populating both SVSTDTC and SVENDTC with the single date for a visit. When there are multiple dates and/or date/times for a visit for a particular subject, the derivation of values for SVSTDTC and SVENDTC may be more complex. The method for deriving these values should be consistent with the visit definitions in the Trial Visits (TV) dataset (See section 3.3.1.1.1, Schedule for Assessments (TV)).

For some studies, a visit may be defined to correspond with a clinic visit that occurs within 1 day, whereas for other studies, a visit may reflect data collection over a multiday period.

The SV dataset provides reviewers with a summary of a subject’s visits over the course of their participation in a study. Comparison of an individual subject’s SV dataset with the TV dataset, which describes the planned visits for the trial, supports the identification of planned but not expected visits due to a subject not completing the study. Comparison of the values of SVSTDY and SVENDY to VISIT and/or VISITDY can often highlight departures from the planned timing of visits.

The data below represents the visits for a single subject.

Row 1:	Data for the screening visit was gathered over the course of 6 days.
Row 2:	The visit called "DAY 1" started and ended as planned, on day 1.
Row 3:	The visit scheduled for day 8 occurred one day early, on day 7.
Row 4:	The visit called "WEEK 2" started and ended as planned, on day 15.
Row 5:	Shows an unscheduled visit. SVUPDES provides the information that this visit dealt with evaluation of an adverse event. Since this visit was not planned, VISITDY was not populated. The applicant chose not to populate VISIT. VISITNUM was populated, probably because the data collected at this encounter is in a Findings domain such as EG, LB, or VS, in which VISIT is treated as an important timing variable.
Row 6:	This subject had their last visit, a follow-up visit on study day 26, 8 days after the unscheduled visit, but well before the scheduled visit day of 71.

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Row	STUDYID	DOMAIN	USUBJID	VISITNUM	VISIT	VISITDY	SVSTDTC	SVENDTC	SVSTDY	SVENDY	SVUPDES
1	123456V	SV	101	1	SCREEN	-7	2006-01-15	2006-01-20	-6	-1
2	123456V	SV	101	2	DAY 1	1	2006-01-21	2006-01-21	1	1
3	123456V	SV	101	3	WEEK 1	8	2006-01-27	2006-01-27	7	7
4	123456V	SV	101	4	WEEK 2	15	2006-02-04	2006-02-04	15	15
5	123456V	SV	101	4.1			2006-02-07	2006-02-07	18	18	Evaluation of AE
6	123456V	SV	101	8	FOLLOW-UP	71	2006-02-15	2006-02-15	26	26

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Subject Visits (SV)