This is an example of a SDTM dataset that represents data collected on a protocol inclusion/exclusion CRF. The IECAT column uses the controlled terminology EXCLUSION, or INCLUSION. IETEST and IETESTCD are defined in the TI domain.
Rows 1-2:
Show data for a subject with 2 inclusion/exclusion exceptions.
Rows 3-4:
Show data for 2 other subjects, both of whom failed the same inclusion criterion.
ie.xpt
ie.xpt
Row
STUDYID
DOMAIN
USUBJID
IESEQ
IESPID
IETESTCD
IETEST
IECAT
IEORRES
IESTRESC
VISITNUM
VISIT
VISITDY
IEDTC
IEDY
1
XYZ
IE
XYZ-0007
1
17
EXCL17
Ventricular Rate
EXCLUSION
Y
Y
1
WEEK -8
-56
1999-01-10
-58
2
XYZ
IE
XYZ-0007
2
3
INCL03
Laboratory Test result abnormal
INCLUSION
N
N
1
WEEK -8
-56
1999-01-10
-58
3
XYZ
IE
XYZ-0047
1
3
INCL03
Laboratory Test result abnormal
INCLUSION
N
N
1
WEEK -8
-56
1999-01-12
-56
4
XYZ
IE
XYZ-0096
1
3
INCL03
Laboratory Test result abnormal
INCLUSION
N
N
1
WEEK -8
-56
1999-01-13
-55
Dataset Debug Message
There are six leading, trailing, or non-breaking spaces in the dataset.