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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:
- 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.
- Examples in this supplement assume that no protocol modifications were made to RECIST 1.1.
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