RECISTv1.1 Module Definition
The Response Evaluation Criteria in Solid Tumors (RECIST) CRF module is used to document the questions collected when assessing the change in tumor burden as part of the clinical evaluation of cancer therapies using the RECIST guidelines. This working group utilized a proposed set of questions and data elements that were the result of a joint National Cancer Institute – Clinical Data Interchange Standards Consortium (NCI-CDISC) standardization effort that completed just prior to the initiation of the Round 5 working group activities.
This module is constrained to content in the RECISTv1.1 guidelines, and is not inclusive of the earlier RECISTv1.0 guideline or extensions of the standard in guidelines by other organizations such as the World Health Organization (WHO) and the CDISC. There is one exception, the inclusion of a single CDISC question which is conditional when an organization may be reporting their RECIST data based on the CDISC Study Data Tabulation Module (SDTM) format.
The RECISTv1.1 CRF module variables, or questions, have been divided into 4 groupings as viewed by researchers and statisticians:
RECIST v1.1 NCI CRF Standards created on October 30, 2018
iRECIST NCI Standards created on October 30, 2018
irRECIST NCI Standards created on October 30, 2018
irRC NCI Standards created on October 30, 2018
RECIST NCI CRF Standards created on June 11th, 2018
Until the latest release of the NCI CRF Standards has been posted to the Wiki, please send a request for a copy of the module to caDSR.RA@mail.nih.gov.
RECISTv1.1 NCI CRF Standards created on December 9th, 2013
* Represents working group leads
|7||Kristen||Engel||GOG Statistical and Data Center|
|11||Eleanor||Leung-Hollins||CALGB/Alliance Statistics and Data Center (Duke)|
|14||Susan||Panonni||City of Hope|