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These specific implementation details for the disease response criteria are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.
The CDISC Intellectual Property Policy can be found on the CDISC web site at: https://www.cdisc.org/about/bylaws.
1.1 Representations and Warranties, Limitations of Liability, and Disclaimers
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Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.
CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the criteria beyond the normal license fees charged by the copyright holder.
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- E.A. Eisenhauer, P. Therasse, J. Bogaerts, L.H. Schwartz, D. Sargent, R. Ford, J. Dancey, S. Arbuck, S. Gwyther, M. Mooney, L. Rubinstein, L. Shankar, L. Dodd, R. Kaplan, D. Lacombe, J. Verweij. New response evaluation criteria in solid tumours; Revised RECIST guideline (version 1.1). European Journal of Cancer 2009; 45:228-247.
- https://recist.eortc.org/recist-1-1-2/
3 The Oncology Disease Response and Supporting Domains Model for RECIST 1.1
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SDTM dataset specializations have been defined for the TU, TR, and RS datasets. They are retrievable via the CDISC Library API as JSON output. See the CDISC Biomedical Concepts page for more information https://www.cdisc.org/cdisc-biomedical-concepts.
3.1 Assumptions for the Oncology Disease Response and Supporting Domains Model
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The CDISC Oncology Codetable (available at https://www.cdisc.org/standards/terminology/controlled-terminology) contains the valid value list for the tests in the TU, TR, and RS domains.
RSORRES is populated with the original result and RSSTRESC is populated with the standardized character result according to the associated controlled terminology. For example, RSORRES = "CR" and RSSTRESC = "CR" where "CR" is a valid value in the associated controlled terminology.
- TUORRES is populated with the original result and TUSTRESC is populated with the standardized character result according to the associated controlled terminology. For example, TUORRES = "TARGET" and TUSTRESC = "TARGET" where "TARGET" is a valid value in the associated controlled terminology.
For the TR domain, TRORRES and TRSTRESC can contain numeric or character results and TRSTRESN is only populated for numeric results. There are situations when a character result in TRORRES is standardized to a numeric representation of the result in TRSTRESC and TRSTRESN.
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