This 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.
pr.xpt
pr.xpt
Row
STUDYID
DOMAIN
USUBJID
SPDEVID
PRSEQ
PRREFID
PRLNKID
PRTRT
PRLOC
PRSTDTC
1
DMD-RT
PR
DMD-RT-01-301
ABC001
1
12345678
04
MRI
HEART
2023-08-01
$warningHtml
This example cardiovascular system findings (CV) dataset shows how to represent longitudinal relaxation time, transverse relaxation time, and extracellular volume findings from CMR imaging. 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. An NSV 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 the LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT 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".
cv.xpt
cv.xpt
Row
STUDYID
DOMAIN
USUBJID
CVSEQ
CVLNKID
CVTESTCD
CVTEST
CVORRES
CVORRESU
CVSTRESC
CVSTRESN
CVSTRESU
CVSTAT
CVREASND
CVLOC
CVMETHOD
CVLOBFXL
VISITNUM
VISIT
CVTPT
CVTPTREF
CVDTC
CVOIQ
1
DMD-RT
CV
DMD-RT-01-301
1
04
T1
Longitudinal Relaxation Time
1315
ms
1315
1315
ms
LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT
MRI
1
VISIT 1
BEFORE
CONTRAST ADMINISTRATION
2023-08-01
EVALUABLE IMAGE
2
DMD-RT
CV
DMD-RT-01-301
2
04
T1
Longitudinal Relaxation Time
1166
ms
1166
1166
ms
LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT
MRI
1
VISIT 1
BEFORE
CONTRAST ADMINISTRATION
2023-08-01
EVALUABLE IMAGE
3
DMD-RT
CV
DMD-RT-01-301
3
04
T1
Longitudinal Relaxation Time
980
ms
980
980
ms
LEFT VENTRICULAR BASAL INFERIOR SEGMENT
MRI
1
VISIT 1
BEFORE
CONTRAST ADMINISTRATION
2023-08-01
EVALUABLE IMAGE
4
DMD-RT
CV
DMD-RT-01-301
4
04
T2
Transverse Relaxation Time
45
ms
45
45
ms
LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT
MRI
1
VISIT 1
BEFORE
CONTRAST ADMINISTRATION
2023-08-01
EVALUABLE IMAGE
5
DMD-RT
CV
DMD-RT-01-301
5
04
T2
Transverse Relaxation Time
40
ms
40
40
ms
LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT
MRI
1
VISIT 1
BEFORE
CONTRAST ADMINISTRATION
2023-08-01
EVALUABLE IMAGE
6
DMD-RT
CV
DMD-RT-01-301
6
04
T2
Transverse Relaxation Time
48
ms
48
48
ms
LEFT VENTRICULAR BASAL INFERIOR SEGMENT
MRI
1
VISIT 1
BEFORE
CONTRAST ADMINISTRATION
2023-08-01
EVALUABLE IMAGE
7
DMD-RT
CV
DMD-RT-01-301
7
04
T1
Longitudinal Relaxation Time
450
ms
450
450
ms
LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT
MRI
1
VISIT 1
AFTER
CONTRAST ADMINISTRATION
2023-08-01
EVALUABLE IMAGE
8
DMD-RT
CV
DMD-RT-01-301
8
04
MYECV
Myocardial Extracellular Volume
25
%
25
25
%
LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT
MRI
1
VISIT 1
AFTER
CONTRAST ADMINISTRATION
2023-08-01
EVALUABLE IMAGE
9
DMD-RT
CV
DMD-RT-01-302
1
CVALL
Cardiovascular System Findings
NOT DONE
NON-EVALUABLE IMAGE
HEART
MRI
1
VISIT 1
CONTRAST ADMINISTRATION
2023-08-05
NON-EVALUABLE IMAGE
10
DMD-RT
CV
DMD-RT-01-303
1
CVALL
Cardiovascular System Findings
NOT DONE
UNABLE TO PLACE INTRAVENOUS LINE
HEART
MRI
1
VISIT 1
CONTRAST ADMINISTRATION
2023-08-05
$warningHtml
CV NSV Metadata
Variable
Label
Type
Role
Origin
CVOIQ
Overall Image Quality
text
Non-standard Record Qualifier
CRF
Dataset Wrapper Debug Message
Please add a row column to your dataset.
The example Procedure Agents (AG) dataset shows details for the gadolinium-based contrast used for the procedure.
ag.xpt
ag.xpt
Row
STUDYID
DOMAIN
USUBJID
AGSEQ
AGLNKID
AGTRT
AGCAT
AGDOSE
AGDOSU
AGDOSFRM
AGROUTE
AGSTDTC
1
DMD-RT
AG
DMD-RT-01-301
1
04
Gd-DOTA
CONTRAST AGENT
8
mL
SOLUTION
INTRAVENOUS
2023-08-01
$warningHtml
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.