The example procedures (PR) dataset includes the SPDEVID variable to show what device was used and the PRREFID variable to represent the accession number or procedure reference identifier associated with the specific procedure. SPDEVID was used to link this PR record to the device records below.
pr.xpt
pr.xpt
Row
STUDYID
DOMAIN
USUBJID
SPDEVID
PRSEQ
PRREFID
PRLNKID
PRTRT
PRSTDTC
1
DMD-RT
PR
DMD-RT-01-301
ABC001
1
12345678
04
CARDIAC MAGNETIC RESONANCE IMAGING
2023-08-01
$warningHtml
The example cardiovascular system findings (CV) dataset below shows how to represent longitudinal relaxation time, transverse relaxation time and extracellular volume findings from CMR. This example includes records for an unreadable image and an unperformed test. For these records, CVSTAT was populated with "NOT DONE" and CVREASND was populated with the reason the result was not provided or the procedure was not done. A non-standard variable was used to represent image quality.
Rows 1-6:
Show the longitudinal relaxation time and the transverse relaxation time for different segments of the heart prior to contrast (CVTPT = BEFORE and CVTPTREF = CONTRAST ADMINISTRATION).
Rows 7-8:
Show the longitudinal relaxation time and myocardial extracellular volume for different segments of the heart after contrast (CVTPT = AFTER and CVTPTREF = CONTRAST ADMINISTRATION).
Row 9:
Shows an unreadable CMR result for participant DMD-RT-01-302, CVREASND = "NON-EVALUABLE IMAGE".
Row 10:
Shows participant DMD-RT-01-303 did not have a CMR procedure because they were unable to place an intravenous access line, CVREASND = "UNABLE TO PLACE INTRAVENOUS LINE".
The device identifiers (DI) domain is used to represent the device information details. Characteristics recorded in a DI dataset are those necessary to identify each device to the level of granularity necessary for the study (e.g., to the model level if knowing the actual unit is not necessary, to the serial number level if there is a need to distinguish among units).
di.xpt
di.xpt
Row
STUDYID
DOMAIN
SPDEVID
DISEQ
DIPARMCD
DIPARM
DIVAL
1
DMD-RT
DI
ABC001
1
DEVTYPE
Device Type
CMR Scanner
2
DMD-RT
DI
ABC001
2
MANUF
Manufacturer
ACME
3
DMD-RT
DI
ABC001
3
TRADENAM
Trade Name
ACME 64
4
DMD-RT
DI
ABC001
4
MODEL
Model Number
CMR540
$warningHtml
Fixed properties of devices are represented in the device properties (DO) domain. The sponsor chose to keep the software version constant throughout the study.
do.xpt
do.xpt
Row
STUDYID
DOMAIN
SPDEVID
DOSEQ
DOTESTCD
DOTEST
DOORRES
DOORRESU
1
DMD-RT
DO
ABC001
1
SFTWRNAM
Software Name
CMRRLXU2
2
DMD-RT
DO
ABC001
2
SFTWRVER
Software Version
CMRLX.2
3
DMD-RT
DO
ABC001
3
IMAQDIM
Image Acquisition Dimensionality
3
$warningHtml
Changeable properties and parameters of devices are represented in the device in-use (DU) domain. These settings can be linked to records in the CV dataset by their shared SPDEVID and DTC values. For brevity, only 1 subject's parameters are shown.
du.xpt
du.xpt
Row
STUDYID
DOMAIN
USUBJID
SPDEVID
DUSEQ
DUREFID
DUTESTCD
DUTEST
DUORRES
DUORRESU
DUSTRESC
DUSTRESN
DUSTRESU
DUDTC
1
DMD-RT
DU
DMD-RT-01-301
ABC001
1
12345678
ANTPLAN
Anatomical Plane
SAGITTAL
SAGITTAL
2023-08-01
2
DMD-RT
DU
DMD-RT-01-301
ABC001
2
12345678
PULSSEQ
Pulse Sequence
SPGR
SPGR
2023-08-01
3
DMD-RT
DU
DMD-RT-01-301
ABC001
3
12345678
FLIPANGL
Flip Angle
50
deg
50
50
deg
2023-08-01
4
DMD-RT
DU
DMD-RT-01-301
ABC001
4
12345678
INTDISTM
Interslice Distance
1
mm
1
1
mm
2023-08-01
5
DMD-RT
DU
DMD-RT-01-301
ABC001
5
12345678
STHICK
Slice Thickness
6
mm
6
6
mm
2023-08-01
6
DMD-RT
DU
DMD-RT-01-301
ABC001
6
12345678
FLDVIEW
Field of View
32X38
cm
32X38
32X38
cm
2023-08-01
7
DMD-RT
DU
DMD-RT-01-301
ABC001
7
12345678
NUMSLICE
Number of Slices
12
12
12
2023-08-01
8
DMD-RT
DU
DMD-RT-01-301
ABC001
8
12345678
COILSTR
Coil Strength
1.5
T
1.5
1.5
T
2023-08-01
$warningHtml
The RELREC dataset is used to describe the relationship between 2 or more records in different domains.