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| Title | Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Item Library Version 1.0 Version Date 4/26/2020 (PRO-CTCAE V1.0 VERSION DATE 4/26/2020) |
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| CDISC Reference | QuestionnaireSupplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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| QRS Short Name | PRO-CTCAE V1.0 VERSION DATE 4/26/2020 |
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| QRS Permission Status | Approved |
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| Team | Pancreatic Cancer Therapeutic Area Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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| Supplement Version | 1.0 |
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| Status | DRAFT |
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| Date | 2022-0203-1501 |
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| 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. |
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Revision History
| Date | Version |
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| 2022-0203-1501 | 1.0 Draft |
© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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This document describes the CDISC implementation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Item Library Version 1.0 Version Date 4/26/2020 (PRO-CTCAE V1.0 VERSION DATE 4/26/2020) instrument.
CDISC does did not modify QRS instruments to this questionnaires, ratings, and scales (QRS) instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.
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