Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

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.

Dataset wrap
Namepr
Dataset2
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

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.

Dataset wrap
Namecv
Rowcaps

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"
Info
titleNotes
  • CVORRES: Result of the measurement or finding as originally received or collected.
  • CVORRESU: Original units in which the data were collected. Unit for CVORRES.
  • CVSTRESC: Result value for all findings from CVORRES in a standard format or in standard units. If results are numeric, they should also be stored in numeric format in CVSTRESN.
  • CVSTRESN: Used for continuous or numeric results or findings in standard format; copied in numeric format from CVSTRESC.
  • CVSTRESU: Standardized units used for CVSTRESC and CVSTRESN.
  • CVLOBXFL: Last Observation Before Exposure Flag. Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null.

...

.
Dataset2

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-01-301104T1
LONGITUDINAL RELAXATION TIME (T1 time)
Longitudinal Relaxation Time

1315

ms

1315

1315ms



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING1

MRI
1VISIT 1BEFORECONTRAST ADMINISTRATION
SCREENING
2023-08-01
EVALUABLE IMAGE
2DMD-RTCVDMD-RT-01-301204T1
LONGITUDINAL RELAXATION TIME (T1 time)
Longitudinal Relaxation Time1166ms11661166ms

LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING1
MRI
1VISIT 1BEFORECONTRAST ADMINISTRATION
SCREENING
2023-08-01
EVALUABLE IMAGE
3DMD-RTCVDMD-RT-01-301304T1
Longitudinal Relaxation Time

980

ms

980

980ms
LONGITUDINAL RELAXATION TIME (T1 time)


LEFT VENTRICULAR BASAL INFERIOR SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING
MRI
1
SCREENING
VISIT 1BEFORECONTRAST ADMINISTRATION2023-08-01
EVALUABLE IMAGE
4DMD-RTCVDMD-RT-01-301404T2
TRANSVERSE RELAXATION TIME (T2 time)
Transverse Relaxation Time

45

ms4545ms



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING1

MRI
1VISIT 1BEFORECONTRAST ADMINISTRATION
SCREENING
2023-08-01
EVALUABLE IMAGE
5DMD-RTCVDMD-RT-01-301504T2
TRANSVERSE RELAXATION TIME (T2 time)
Transverse Relaxation Time

40

ms4040ms

LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING1
MRI
1VISIT 1BEFORECONTRAST ADMINISTRATION
SCREENING
2023-08-01
EVALUABLE IMAGE
6DMD-RTCVDMD-RT-01-301604T2
Transverse Relaxation Time

48

ms4848ms
TRANSVERSE RELAXATION TIME (T2 time)


LEFT VENTRICULAR BASAL INFERIOR SEGMENT
CARDIAC MAGNETIC RESONANCE IMAGING1
MRI
1VISIT 1BEFORECONTRAST ADMINISTRATION
SCREENING
2023-08-01
EVALUABLE IMAGE
7DMD-RTCVDMD-RT-01-3017
NATIVE T1 MAPPINGCARDIAC MAGNETIC RESONANCE IMAGING1
04T1Longitudinal Relaxation Time

450

ms450450ms



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

MRI
1VISIT 1AFTERCONTRAST ADMINISTRATION
SCREENING
2023-08-01
EVALUABLE IMAGE
8DMD-RTCVDMD-RT-01-3018
EXTRAVOLEXTRACELLULAR VOLUME
04MYECV

Myocardial Extracellular Volume

25

%2525%



LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT

CARDIAC MAGNETIC RESONANCE IMAGING1
MRI
1VISIT 1AFTERCONTRAST ADMINISTRATION
SCREENING
2023-08-01
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

Nsvmeta
DomainCV

Variable

Label

Type

Role

Origin

CVOIQOverall Image QualitytextNon-standard Record QualifierCRF

The example Procedure Agents (AG) dataset shows details for the gadolinium-based contrast used for the procedure.

SCREENING
Dataset wrap
Nameag
Dataset2

Row

STUDYID

DOMAIN

USUBJID

AGSEQ

AGLNKID

AGTRT

AGCAT

AGDOSE

AGDOSU

AGDOSFRM

AGROUTE

AGSTDTC

1

DMD-RT

AG

DMD-RT-01-301

9EXTRAVOLLEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENTCARDIAC MAGNETIC RESONANCE IMAGING1

1

04

Gd-DOTA

CONTRAST AGENT

8

mL

SOLUTION

INTRAVENOUS

2023-08-01

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).

Dataset wrap
Namedi
Dataset2

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

Fixed properties of devices are represented in the Device Properties (DO) domain. The sponsor chose to keep the software version constant throughout the study.

Dataset wrap
Namedo
Dataset2
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

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.

SCREENING
Dataset wrap
Namedu
Dataset2
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

10
8

DMD-RT

CV30110EXTRAVOLLEFT VENTRICULAR BASAL INFERIOR SEGMENTCARDIAC MAGNETIC RESONANCE IMAGING1

DU

DMD-RT-01-301

ABC001

8

12345678

COILSTRCoil Strength1.5T1.51.5T

2023-08-01

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

Dataset wrap
Namerelrec
Dataset2

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