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• Conceptual/abstract layer that provides standards-agnostic, unambiguous semantic definition largely based on NCIt concepts
• Implementation layer based on valid CDISC dataset specializations that provide value-level metadata definitions that facilitate metadata-driven automation

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In TR, TRDTC is populated with the date of tumor/lesion assessment/measurement (e.g., date of the scan, image, physical exam). In the examples, the summary results (e.g., Sum of Diameter) do not have TRMETHOD and TRDTC associated with them. However, if an appropriate TRDTC is available, it can be populated. In TR, scans which are not performed do not have TRDTC populated.

Note that:

1. Examples in this supplement are based on assumptions about data collection forms. For example, the collection of split and merged tumors may be collected in different ways depending on the form design and system limitations. The preferred SDTM data representation is shown in the examples.
2. Examples in this supplement assume that no protocol modifications were made to RECIST 1.1.

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4.3 Example 3: Scans Either Not Done or Not Evaluable

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4.4 Example 4: Accepted Record Flag for Multiple Independent Assessors

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The following supptu.xpt table shows the data describing the disease presentation of non-target tumors. The tumor presentation type (QNAM = "TUPRTYP") supplemental qualifier is used and controlled terminology is available (DSPRTYP). In addition, this example shows the plane of measurement and the slice number where the lesions lesion was identified.

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