CDISC has published the first of a new kind of QRS supplement to the SDTMIG, a supplement for an oncology response criterion, Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
The RECIST 1.1 supplement can be found in the QRS section of the CDISC website, QRS. The SDS Oncology Team is working to develop supplements for additional oncology disease response criteria.
The structure of an oncology disease response supplement differs from the structure of most other supplements for clinical classifications represented in the RS domain.
Section 4, SDTM Mapping Strategy
| Oncology RS Supplements Sections | Sections in Most Other RS Supplements |
| Section 1, Introduction | Section 1, Introduction |
| Section 2, Copyright Information | Section 2, Copyright Information |
| Section 3, RS and Supporting Domain Models 3.1 Assumptions 3.2 General Points on Representing Data | Section 3, The RS Domain Model 3.1 Assumptions 3.2 Example |
| Section 4, Examples | Section 4, SDTM Mapping Strategy |
| Section 5, RELREC |
An oncology disease response supplement is more extensive than most clinical classification supplements because:
- It covers the supporting domains (Tumor/Lesion Identification [TU], Tumor/Lesion Results [TR], and Procedures [PR].
- It includes Section 3.2, which explains some of the complexities of representing disease response data.
- It includes multiple examples with the PR, TU, TR, and RS domains, rather than the one RS example typically included in a clinical classification supplement. Examples within an oncology disease response supplement support various use cases for the disease response criteria of interest.
- It covers the RELREC dataset needed to tie the RS and supporting domains together.