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Title

Non-Small Cell Lung Cancer Symptom Assessment Questionnaire v1.0 (NSCLC-SAQ V1.0)

CDISC Reference

Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials

QRS Short Name

NSCLC-SAQ V1.0

QRS Permission StatusApproved
TeamLung Cancer Standards Team and CDISC Questionnaires, Ratings and Scales (QRS) Subteam
Supplement Version1.0
StatusFinal
Date2020-0103-1310
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.


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Revision History

DateVersion
2020-0103-13101.0

© 2020 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols.

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

Critical Path Institute owns the copyright for the NSCLC-SAQ V1.0 and has granted CDISC permission to include this supplement in the CDISC library of QRS data standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the questionnaire. There may be many versions of this instrument in the public domain or copyrighted. CDISC has chosen to use this version as the data standard.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values.

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology.

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