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Comment: clarified copyright statement (section 2) and removed the pink information box at the end.

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2 Copyright Status

The RECIST Working Group owns and European Journal of Cancer (EJC) own the copyright for the RECIST 1.1 guidelines and have made the RECIST 1.1 disease response criteria. CDISC has guidelines available for non-commercial purposes exempt from copyright restrictions. All other rights are reserved. CDISC has included this supplement in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed data standards for tumor identification, tumor results and disease response, and applied these to RECIST 1. 1. Examples were developed to represent RECIST 1.1 and were included in the CDISC library of QRS data standards supplements.

The CDISC documentation of the criteria consists of: (1) controlled terminology and (2) standard data structures with examples.

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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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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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Dataset wrap
Namesuppqual


QNAMRDOMAINQLABELTYPECODELISTROLE
RSREASNERSReason Response Not EvaluabletextFree text from CRF

Non-Standard Record Qualifier

TUPRVIR

TUPreviously Irradiated IndicatortextNY

Non-Standard Record Qualifier

TUPRVIRPTUPreviously Irradiated ProgressiontextNY

Non-Standard Record Qualifier

TUPRTYPTUTumor Presentation TypetextDSPRTYP

Non-Standard Record Qualifier

TULOCDTLTULocation DetailtextFree text from CRF

Non-Standard Record Qualifier

TUSLNUMTUSlice NumbertextFree text from CRF

Non-Standard Record Qualifier

TUPLOMSRTUPlane of MeasurementtextFree text from CRF

Non-Standard Record Qualifier

PRLOC1PRLocation of Procedure 1textLOC

Non-Standard Record Qualifier

PRLOC2PRLocation of Procedure 2textLOC

Non-Standard Record Qualifier

PRSLTHKPRSlice ThicknesstextFree text from CRF

Non-Standard Record Qualifier

PROIQPROverall Image QualitytextFree text from CRF

Non-Standard Record Qualifier

End of Document

Info

To set up your dataset wrapper, row caption, dataset combination when in edit mode:

  • Type "{dataset" (no quotes)
  • Choose "Dataset Wrapper" and hit return.  
  • Then place your cursor in the grey box, type "{row" (no quotes) and choose "Row Captions" and hit return.  
  • Finally place the cursor below that box and do the same with "{dataset" and clicking "Dataset".

Now you can select your table from Excel, copy, and then paste (control v) into the dataset box. To be sure there are no extraneous formats, if you click the grey bar at the top of the dataset macro, it will select all of the data in the table. You can now go to the top of the edit window, click on the down arrow by the A and click "Clear formatting" to clean up the table.

Feel free to delete this info box whenever you'd like (smile)


End of Document