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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
Date2022-0809-1107
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 to be released in the SDTMIG v4.0. This new variable will streamline the data representation of conditional branched items.

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Revision History


DateVersion
2022-0809-11071.0 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.

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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. 

2 Copyright Status

The PRO-CTCAE® Measurement System is owned exclusively by National Cancer Institute.The National Cancer Institute (NCI) is the owner of the PRO-CTCAE V1.0measurement system

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyQRSSUPP-460
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. 

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