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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
Date2023-12-08
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 “Conditionally Branched Item Flag” has been requested approved for release in SDTMIG v4.0. This new variable will streamline the data representation of conditional conditionally branched items.


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This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols. CDISC disclaims any liability for your use of this material.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument. 

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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/).

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CDISC has developed this documentation at no cost to copyright the owner, trademark 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.

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The SUPPQS dataset shows the items in the QS dataset which have assigned responses (QSDRVFL QSCBRFL = "Y") due to electronic conditional branching and also relates the symptom terms from the annotated Item Library v1.0 form to each symptom item represented in the QS dataset.

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