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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

PRLOC

PRSTDTC

1

DMD-RT

PR

DMD-RT-01-301

ABC001

1

12345678

04

MRI

HEART

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".

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

1DMD-RTCVDMD-RT-01-301104T1Longitudinal Relaxation Time (T1 Time)

1315

ms

1315

1315ms



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

MRI
1VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
2DMD-RTCVDMD-RT-01-301204T1Longitudinal Relaxation Time (T1 Time)1166ms11661166ms

LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENTMRI
1VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
3DMD-RTCVDMD-RT-01-301304T1Longitudinal Relaxation Time (T1 Time)

980

ms

980

980ms

LEFT VENTRICULAR BASAL INFERIOR SEGMENTMRI
1VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
4DMD-RTCVDMD-RT-01-301404T2Transverse Relaxation Time (T2 Time)

45

ms4545ms



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

MRI
1VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
5DMD-RTCVDMD-RT-01-301504T2Transverse Relaxation Time (T2 Time)

40

ms4040ms

LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENTMRI
1VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
6DMD-RTCVDMD-RT-01-301604T2Transverse Relaxation Time (T2 Time)

48

ms4848ms

LEFT VENTRICULAR BASAL INFERIOR SEGMENTMRI
1VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
7DMD-RTCVDMD-RT-01-301704T1Longitudinal Relaxation Time (T1 Time)

450

ms450450ms



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

MRI
1VISIT 1AFTERCONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
8DMD-RTCVDMD-RT-01-301804MYECV

Myocardial Extracellular Volume

25

%2525%



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

MRI
1VISIT 1AFTERCONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
9DMD-RTCVDMD-RT-01-3021
CVALLCardiovascular System Findings




NOT DONE

NON-EVALUABLE IMAGE

HEART

MRI
1VISIT 1
CONTRAST ADMINISTRATION2023-08-05
NON-EVALUABLE IMAGE
10DMD-RTCVDMD-RT-01-3031
CVALLCardiovascular System Findings




NOT DONE

UNABLE TO PLACE INTRAVENOUS LINE

HEART

MRI
1VISIT 1
CONTRAST ADMINISTRATION2023-08-05

$warningHtml

CV NSV Metadata

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

3IMAQDIMImage Acquisition Dimensionality3
$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

ANTPLANAnatomical PlaneSAGITTAL
SAGITTAL

2023-08-01

2

DMD-RT

DU

DMD-RT-01-301

ABC001

2

12345678

PULSSEQPulse SequenceSPGR
SPGR

2023-08-01

3

DMD-RT

DU

DMD-RT-01-301

ABC001

3

12345678

FLIPANGLFlip Angle50deg5050deg

2023-08-01

4

DMD-RT

DU

DMD-RT-01-301

ABC001

4

12345678

INTDISTM

Interslice Distance

1mm11mm

2023-08-01

5

DMD-RT

DU

DMD-RT-01-301

ABC001

5

12345678

STHICKSlice Thickness6mm66mm

2023-08-01

6

DMD-RT

DU

DMD-RT-01-301

ABC001

6

12345678

FLDVIEWField of View32X38cm32X3832X38cm

2023-08-01

7

DMD-RT

DU

DMD-RT-01-301

ABC001

7

12345678

NUMSLICENumber of Slices12
1212

2023-08-01

8

DMD-RT

DU

DMD-RT-01-301

ABC001

8

12345678

COILSTRCoil Strength1.5T1.51.5T

2023-08-01

$warningHtml
The RELREC dataset is used to describe the relationship between 2 or more records in different domains.
$titleHtml

relrec.xpt

Row

STUDYID

RDOMAIN

USUBJID

IDVAR

IDVARVAL

RELTYPE

RELID

1

DMD-RT

PR


PRLNKID


ONE

04

2

DMD-RT

CV


CVLNKID


MANY

04

3

DMD-RT

AG


AGLNKID


ONE

04

$warningHtml

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