Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) Library Version1.0 (PRO-CTCAE V1.0)
CDISC Reference
QuestionnaireSupplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name
PRO-CTCAE V1.0
QRS Permission Status
Approved
Team
Pancreatic Cancer Therapeutic Area Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version
1.0
Status
DRAFT
Date
2022-06-14
Notes
This 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 onthe result of a response compare for a 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.