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Title

Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) Library Version 1.0 (PRO-CTCAE V1.0)

CDISC ReferenceQuestionnaireSupplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

PRO-CTCAE V1.0

QRS Permission StatusApproved
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date20222023-1101-2126
NotesThis supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.
Known Issue
  • The concept of “conditional branching” in QRS instruments is when the instrument directs the subject to another item of the instrument based on the result of a response compare for a given condition. This concept was reviewed with the CDISC standards teams and it was agreed to use this term instead of “logically skipped item” moving forward for this QRS instrument use case. A new QRS variable named “QSCBRFL” with the description of “Conditional Branched Item Indicator” has been requested for release in SDTMIG v4.0. This new variable will streamline the data representation of conditional branched items.

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Revision History

DateVersion
20222023-1101-21261.0 Draft
Info

The CDISC PRO-CTCAE V1.0 supplement Version 1.0 was developed based on the NCI/NIH PRO-CTCAE® website. The website’s PRO-CTCAE Version 1.0 release notes indicate the revisions made by NCI/NIH on the PRO-CTCAE 1.0 measurement system. The measurement system version is 1.0 based on the website's release notes (specific correction of typographical errors in the different CRF translations). NCI/NIH will notify CDISC of any major changes in the future that would require a change control to the CDISC PRO-CTCAE V1.0 supplement version.

© 2022 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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The PRO-CTCAE® Measurement System is owned exclusively by National Cancer Institute (NCI). Use of the PRO-CTCAE V1.0 is subject to NCI terms of use policy listed on the website. Based on these terms of use, CDISC considers this instrument exempt from copyright restrictions. CDISC has included this supplement in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the measurement system. 

The CDISC documentation of this measurement system consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values (referred to hereafter as annotated Item Library v1.0 form).

Note: CDISC Controlled Terminology is maintained by 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 copyright holder or any additional cost to users of the measurement system beyond the normal licenses fees charged by the copyright holder.

CDISC acknowledges Sandra Mitchell, PhD, CRNP, Research Scientist and Program Director Scientific Lead, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Outcomes Research Branch, Healthcare Delivery Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, for the approval to include the PRO-CTCAE V1.0 in the CDISC data standards.

References for the PRO-CTCAE V1.0:

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  • These materials discuss and/or include the PRO-CTCAE® Item Library Version 1.0 (PRO-CTCAE V1.0). The PRO-CTCAE® Measurement System is owned exclusively by the National Cancer Institute. No part of the PRO-CTCAE® Measurement System may be adapted, altered, amended, abridged, modified, condensed, made into derivative works, or translated without prior written permission from the US National Cancer Institute. PRO-CTCAE is a registered trademark of the US Department of Health & Human Services. All rights reserved. For additional terms of use and to access PRO-CTCAE® Measurement System content, visit https://healthcaredelivery.cancer.gov/pro-ctcae/
  • The PRO-CTCAE trademark items and information herein were developed by the Division of Cancer Control and Population Sciences in the National Cancer Institute at the National Institutes of Health, Bethesda, Maryland, USA. Use of the PRO-CTCAE is subject to NCI’s Terms of Use. PRO-CTCAE Measurement System content should be downloaded using the Instruments & Form Builder link (https://healthcaredelivery.cancer.gov/pro-ctcae/).

The CDISC documentation of this measurement system consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values (referred to hereafter as annotated Item Library v1.0 form).

Note: CDISC Controlled Terminology is maintained by 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 copyright holder or any additional cost to users of the measurement system beyond the normal licenses fees charged by the copyright holder.

CDISC acknowledges Sandra Mitchell, PhD, CRNP, Research Scientist and Program Director Scientific Lead, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Outcomes Research Branch, Healthcare Delivery Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, for the approval to include the PRO-CTCAE V1.0 in the CDISC data standards.

References for the PRO-CTCAE V1.0:

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  • Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, Mendoza TR, Hay J, Atkinson TM, Abernethy AP, Bruner DW, Cleeland CS, Sloan JA, Chilukuri R, Baumgartner P, Denicoff A, St Germain D, O'Mara AM, Chen A, Kelaghan J, Bennett AV, Sit L, Rogak L, Barz A, Paul DB, Schrag D. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).J Natl Cancer Inst 2014 Sep 29;106(9)).
  • National Institutes of Health – National Cancer Institute, Division of Cancer Control & Population Sciences. (2017, July 2) https://healthcaredelivery.cancer.gov/pro-ctcae/overview.html

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