SDTM. Parametric Mapping

The example includes information about how to represent imaging device information in the event that the research requires this type of data.

The PR dataset shows the procedure of cardiac magnetic resonance imaging using the device associated with SPDEVID ABC001 and the PRREFID of 12345678. This information shows what CMR device is used for the procedure and the accession number or procedure reference identifier associated with the specific procedure for USUBJID 301. The SPDEVID variable is used to relate records by the device (in this case, the CMR machine). The Device Identifier (DI) dataset holds the device information details, the Device Properties (DO) dataset holds characteristics of the device that do not vary over the between subjects. The Device-In-Use (DU) dataset holds settings that are set on a device when it is used and may vary between participants.

The Cardiovascular System Findings (CV) dataset contains physiological and morphological findings related to the cardiovascular system so it holds the assessments from the parametric mapping. The 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." In the example below, row 9 represents and unreadable CMR using CVSTAT variable to show the reading was "NOT DONE" and the CVREASND variable to show the reason the procedure was not done, or in this case the result not provided which was a "Non-Evaluable" image . A similar approach may be used if there is a desire to record that the CMR was not obtained at the specific visit (omitting the poor quality information) and why in the dataset records. The non-standard variable CVOIQ/ Cardiovascular Overall Image Quality is used to represent if the image for the particular evaluation is "Non-evaluable", "Evaluable", "Evaluable Image - Sub-optimal", or "Evaluable Image -Optimal".The AG dataset shows the Gadolinium based contrast that was used for the procedure. In this example, the researchers did not collect the time of the contrast.DI holds the device identifier information that describes the device used to produce the image that was the basis of the interpretation recorded in the CV domain. Characteristics in DI 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).Fixed properties of devices identified in DI 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. Changeable properties and parameters of the devices identified in DI are represented in the DU domain. These settings could be linked to the record in the CV domain by their shared SPDEVID and DTC values. For the sake of brevity, only 1 subject's parameters are shown. For more information on relating records, see SDTMIG v3.4 Section 8.2, Relating Peer Records. 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.