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RECIST 1.1 is a set of criteria used to evaluate the activity and efficacy of anti-neoplastic agents in solid tumors. The "Oncology Disease Response and Supporting Domains Model for RECIST 1.1" encompasses the subset of SDTMIG domains used for the representation of RECIST 1.1 disease response , and supporting tumor/lesion data , and procedure data in oncology studies. The SDTMIG domains used include:
- Disease Response and Clin Classification (RS) is a findings domain used to represent disease response findings and QRS clinical classifications instruments. The disease responses based on RECIST 1.1 are represented in RS.
- Tumor/Lesion Identification (TU) is a findings domain. The supporting tumor identification of RECIST 1.1 target, non-target and new tumors are represented in the TU domain.
- Tumor/Lesion Results (TR) is a findings domain. The supporting tumor measurements and assessments of the RECIST 1.1 target, non-target and new tumors are represented in the TR domain.
Note that the Procedures (PR)
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domain is not required for RECIST 1.1 but it may be used to represent scan data including medical photography data
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.
These domains are related using RSLNKGRP, TULNKID, TUREFID, TRLNKID, TRLNKGRP, TRREFID and PRREFID. See Section 5 for more information on the relationships and an example RELREC dataset.
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