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.
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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 | HEART | 2023-08-01 |
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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.
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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 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" |
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- 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.
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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 | T1 |
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LONGITUDINAL RELAXATION TIME (T1 time)| Longitudinal Relaxation Time | | ms | | 1315 | ms | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT |
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| CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | MRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION |
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SCREENING | 2023-08-01 |
| EVALUABLE IMAGE | | 2 | DMD-RT | CV | DMD-RT-01-301 | 2 | 04 | T1 |
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LONGITUDINAL RELAXATION TIME (T1 time)| Longitudinal Relaxation Time | 1166 | ms | 1166 | 1166 | ms |
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| LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT |
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CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | MRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION |
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SCREENING | 2023-08-01 |
| EVALUABLE IMAGE | | 3 | DMD-RT | CV | DMD-RT-01-301 | 3 | 04 | T1 |
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| Longitudinal Relaxation Time | | ms | | 980 | ms |
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LONGITUDINAL RELAXATION TIME (T1 time) |
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| LEFT VENTRICULAR BASAL INFERIOR SEGMENT |
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CARDIAC MAGNETIC RESONANCE IMAGINGSCREENING| VISIT 1 | BEFORE | CONTRAST ADMINISTRATION | 2023-08-01 |
| EVALUABLE IMAGE | | 4 | DMD-RT | CV | DMD-RT-01-301 | 4 | 04 | T2 |
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TRANSVERSE RELAXATION TIME (T2 time) | Transverse Relaxation Time | | ms | 45 | 45 | ms | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT |
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CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | MRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION |
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SCREENING | 2023-08-01 |
| EVALUABLE IMAGE | | 5 | DMD-RT | CV | DMD-RT-01-301 | 5 | 04 | T2 |
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TRANSVERSE RELAXATION TIME (T2 time)| Transverse Relaxation Time | | ms | 40 | 40 | ms |
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| LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT |
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CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | MRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION |
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SCREENING | 2023-08-01 |
| EVALUABLE IMAGE | | 6 | DMD-RT | CV | DMD-RT-01-301 | 6 | 04 | T2 |
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| Transverse Relaxation Time | | ms | 48 | 48 | ms |
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TRANSVERSE RELAXATION TIME (T2 time) |
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| LEFT VENTRICULAR BASAL INFERIOR SEGMENT |
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CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | MRI |
| 1 | VISIT 1 | BEFORE | CONTRAST ADMINISTRATION |
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SCREENING | 2023-08-01 |
| EVALUABLE IMAGE | | 7 | DMD-RT | CV | DMD-RT-01-301 | 7 |
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NATIVE T1 MAPPING | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | 04 | T1 | Longitudinal Relaxation Time | | ms | 450 | 450 | ms | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT | MRI |
| 1 | VISIT 1 | AFTER | CONTRAST ADMINISTRATION |
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SCREENING | 2023-08-01 |
| EVALUABLE IMAGE | | 8 | DMD-RT | CV | DMD-RT-01-301 | 8 |
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EXTRAVOL | EXTRACELLULAR VOLUME| 04 | MYECV | Myocardial Extracellular Volume | | % | 25 | 25 | % | | | LEFT VENTRICULAR BASAL ANTEROSEPTAL SEGMENT |
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CARDIAC MAGNETIC RESONANCE IMAGING | 1 | | MRI |
| 1 | VISIT 1 | AFTER | CONTRAST ADMINISTRATION |
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SCREENING | 2023-08-01 |
| EVALUABLE IMAGE | | 9 | DMD-RT | CV | DMD-RT-01-302 | 1 |
| CVALL | Cardiovascular System Findings |
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| | | | 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 |
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| | UNABLE TO PLACE INTRAVENOUS LINE | | MRI |
| 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 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 |
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| 9 | EXTRAVOL | LEFT VENTRICULAR BASAL INFEROSEPTAL SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENING | 1 | 04 | Gd-DOTA | CONTRAST AGENT | 8 | mL | SOLUTION | INTRAVENOUS | 2023-08-01 |
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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).
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Row | STUDYID | DOMAIN | SPDEVID | DISEQ | DIPARMCD | DIPARM | DIVAL |
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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 |
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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.
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| Row | STUDYID | DOMAIN | SPDEVID | DOSEQ | DOTESTCD | DOTEST | DOORRES | DOORRESU |
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| 1 | DMD-RT | DO | ABC001 | | 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 |
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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.
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| Row | STUDYID | DOMAIN | USUBJID | SPDEVID | DUSEQ | DUREFID | DUTESTCD | DUTEST | DUORRES | DUORRESU | DUSTRESC | DUSTRESN | DUSTRESU | DUDTC |
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| 1 | DMD-RT | DU | DMD-RT-01-301 | ABC001 | 1 | 12345678 | ANTPLAN | Anatomical Plane | SAGITTAL |
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| 2023-08-01 | | 2 | DMD-RT | DU | DMD-RT-01-301 | ABC001 | 2 | 12345678 | PULSSEQ | Pulse Sequence | SPGR |
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| 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 | | 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 |
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10 | CV | 301 | 10 | EXTRAVOL | LEFT VENTRICULAR BASAL INFERIOR SEGMENT | CARDIAC MAGNETIC RESONANCE IMAGING | 1 | SCREENINGDU | DMD-RT-01-301 | ABC001 | 8 | 12345678 | COILSTR | Coil Strength | 1.5 | T | 1.5 | 1.5 | T | 2023-08-01 |
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The RELREC dataset is used to describe the relationship between 2 or more records in different domains.
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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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