The example shows the representation of device information, such as the CMR device manufacturer, software and version information, and the specific settings for each subject. Study requirements determine what data is needed.
The example PR dataset shows the cardiac MRI. The device identifier data is represented using SPDEVID and PRREFID. This information shows what device is used and the 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 for subject DMD-RT-01-301. The SPDEVID variable is was used to relate link this PR dataset record to other records by the device (in this case, the CMR machine)records.
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| Row | STUDYID | DOMAIN | USUBJID | SPDEVID | PRSEQ | PRREFID | PRLNKID | PRTRT | PRLOC | PRSTDTC |
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| 1 | DMD-RT | PR | DMD-RT-01-301 | ABC001 | 1 | 12345678 | 04 | MRI | HEARTCARDIAC MAGNETIC RESONANCE IMAGING | 2023-08-01 |
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The This example cardiovascular system findings (CV) dataset below shows how to represent longitudinal relaxation time, transverse relaxation time, and extracellular volume findings from CMR . The timing of the contrast specificity is noted using the CVTPT to note if the CVTEST was done before or after contrast. CVTPTREF associates the timepoints in CVTPT with "contrast administration." 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. The non-standard variable CVOIQ = Overall Image Quality is An NSV was used to represent image quality.
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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 contrastthe 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".
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Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVLNKID | CVTESTCD | CVTEST | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVSTAT | CVREASND | CVLOC | CVMETHOD | CVLOBFXL | VISITNUM | VISIT | CVTPT | CVTPTREF | CVDTC |
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| 1 | DMD-RT | CV | DMD-RT-01-301 | 1 | 04 | T1LONGITUDINAL RELAXATION TIME (T1 TIME) | Longitudinal Relaxation Time | | ms | | 1315 | ms | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION | 2023-08-01 |
| EVALUABLE IMAGE | | 2 | DMD-RT | CV | DMD-RT-01-301 | 2 | 04 | T1LONGITUDINAL RELAXATION TIME (T1 TIME) | Longitudinal Relaxation Time | 1166 | ms | 1166 | 1166 | ms |
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| LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION | 2023-08-01 |
| EVALUABLE IMAGE | | 3 | DMD-RT | CV | DMD-RT-01-301 | 3 | 04 | T1LONGITUDINAL RELAXATION TIME (T1 TIME) | Longitudinal Relaxation Time | | ms | | 980 | ms |
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| LEFT VENTRICULAR BASAL INFERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION | 2023-08-01 |
| EVALUABLE IMAGE | | 4 | DMD-RT | CV | DMD-RT-01-301 | 4 | 04 | T2TRANSVERSE RELAXATION TIME (T2 TIME) | Transverse Relaxation Time | | ms | 45 | 45 | ms | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION | 2023-08-01 |
| EVALUABLE IMAGE | | 5 | DMD-RT | CV | DMD-RT-01-301 | 5 | 04 | T2TRANSVERSE RELAXATION TIME (T2 TIME) | Transverse Relaxation Time | | ms | 40 | 40 | ms |
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| LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION | 2023-08-01 |
| EVALUABLE IMAGE | | 6 | DMD-RT | CV | DMD-RT-01-301 | 6 | 04 | T2TRANSVERSE RELAXATION TIME (T2 TIME) | Transverse Relaxation Time | | ms | 48 | 48 | ms |
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| LEFT VENTRICULAR BASAL INFERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION | 2023-08-01 |
| EVALUABLE IMAGE | | 7 | DMD-RT | CV | DMD-RT-01-301 | 7 | 04 | T1LONGITUDINAL RELAXATION TIME (T1 TIME) | Longitudinal Relaxation Time | | ms | 450 | 450 | ms | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| 1 | VISIT 1 | AFTER | CONTRAST ADMINISTRATION | 2023-08-01 |
| EVALUABLE IMAGE | | 8 | DMD-RT | CV | DMD-RT-01-301 | 8 | 04 | MYECV | MYOCARDIAL EXTRACELLULAR VOLUMEMyocardial Extracellular Volume | | % | 25 | 25 | % | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| 1 | VISIT 1 | AFTER | CONTRAST ADMINISTRATION | 2023-08-01 |
| EVALUABLE IMAGE | | 9 | DMD-RT | CV | DMD-RT-01-302 | 1 |
| CVALLCARDIOVASCULAR SYSTEM FINDINGS | Cardiovascular System Findings |
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| | | | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| 1 | VISIT 1 |
| CONTRAST ADMINISTRATION | 2023-08-05 |
| NON-EVALUABLE IMAGE | | 10 | DMD-RT | CV | DMD-RT-01-303 | 1 |
| CVALLCARDIOVASCULAR SYSTEM FINDINGS | Cardiovascular System Findings |
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| | UNABLE TO PLACE INTRAVENOUS LINE | | CARDIAC MAGNETIC RESONANCE IMAGINGMRI |
| 1 | VISIT 1 |
| CONTRAST ADMINISTRATION | 2023-08-05 |
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| Variable | Label | Type | Role | Origin |
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| CVOIQ | Overall Image Quality | text | Non-standard Record Qualifier | CRF |
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The example Procedure Agents (AG) dataset shows details for the gadolinium-based contrast that was used for the procedure.
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Row | STUDYID | DOMAIN | USUBJID | AGSEQ | AGLNKID | AGTRT | AGCAT | AGDOSE | AGDOSU | AGDOSFRM | AGROUTE | AGSTDTC |
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1 | DMD-RT | AG | DMD-RT-01-301 | 1 | 04 | Gd-DOTA | CONTRAST AGENT | 8 | mL | SOLUTION | INTRAVENOUS | 2023-08-01 |
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The device identifiers 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).
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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 should contain properties that are important for interpreting the data.
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| Row | STUDYID | DOMAIN | SPDEVID | DOSEQ | DOTESTCD | DOTEST | DOORRES | DOORRESU |
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| 1 | DMD-RT | DO | ABC002ABC001 | | SFTWRNAM | Software Name | CMRRLXU2 |
| | 2 | DMD-RT | DO | ABC002ABC001 | 2 | SFTWRVER | Software Version | CMRLX.2 |
| | 3 | DMD-RT | DO | ABC002ABC001 | 3 | IMAQDIM | Image Acquisition Dimensionality | 3 |
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Changeable properties and parameters of devices are represented in the device Device-in-use Use (DU) domain. These settings could can be linked to the record records in the CV domain dataset by their shared SPDEVID and DTC values. For brevity, only 1 subject's parameters are shown.
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The RELREC dataset is used to describe the relationship between 2 or more records in different domains. For more information on relating records, see SDTMIG v3.4, Section 8.2.
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | RELTYPE | RELID |
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1 | DMD-RT | PR |
| PRLNKID |
| ONE | 04 | 2 | DMD-RT | CV |
| CVLNKID |
| MANY | 04 | 3 | DMD-RT | AG |
| AGLNKID |
| ONE | 04 |
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