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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 | 2022-03-1517 |
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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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Date | Version | Summary of Changes |
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2022-03-1517 | 1.0 Draft | Implementation based on the CRF dated 4/26/2020PRO-CTCAE Version 1.0 Release Notes dated 2022-01-28. |
© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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