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The example 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 documented using the CVTPT to note if the CVTEST was done before or after contrast. CVTPTREF associates the timepoints in CVTPT with "contrast administration." = BEFORE or AFTER contrast administration. This example includes records for an unreadable image and an unperformed test. 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 A non-standard variable CVOIQ = Overall Image Quality is used to represent image quality.
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The example AG dataset shows details for the gadolinium based contrast that was used for the procedure.
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Row | STUDYID | DOMAIN | USUBJID | AGSEQ | AGTRT | AGCAT | AGDOSE | AGDOSU | AGDOSFRM | AGROUTE | AGSTDTC |
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1 | DMD-RT | AG | DMD-RT-01-301 | 1 | Gd-DOTA | CONTRAST AGENT | 8 | mL | SOLUTION | INTRAVENOUS | 2023-08-01 |
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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 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 | ABC002 | | SFTWRNAM | Software Name | CMRRLXU2 |
| | 2 | DMD-RT | DO | ABC002 | 2 | SFTWRVER | Software Version | CMRLX.2 |
| | 3 | DMD-RT | DO | ABC002 | 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 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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