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Comment: removed link to approved jira issue qrssupp-490

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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
Date2022-11-0104
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
2022-11-01041.0 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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As stated in Section 3.1 assumptions, the PRO-CTCAE V1.0 symptom terms are grouped into subcategories as represented in the Quick Guide to the Item Library. The table below includes the subcategory names along with the applicable question numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyQRSSUPP-490
on the CRF.

QSSCATQSTESTCD
ORALPT01001A - PT01006A
GASTROINTESTINALPT01007A - PT01018B
RESPIRATORYPT01019A - PT01021A
CARDIO/CIRCULATORYPT01022A - PT01023B
CUTANEOUSPT01024A - PT01038A
NEUROLOGICALPT01039A - PT01040B
VISUAL/PERCEPTUALPT01041A - PT01045A
ATTENTION/MEMORYPT01046A - PT01047B
PAINPT01048A - PT01051C
SLEEP/WAKEPT01052A - PT01053B
MOODPT01054A - PT01056C
GYNECOLOGIC/URINARYPT01057A - PT01065B
SEXUALPT01066A - PT01071A
MISCELLANEOUSPT01072A - PT01080A
OTHER SYMPTOMPT01081 - PT01091B

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