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Title

Functional Assessment of Cancer Therapy-General Version 4 (FACT-G V4)

CDISC ReferenceQuestionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

FACT-G V4

QRS Permission StatusApprove
TeamPancreatic Cancer Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date20022023-1102-2301
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

DateVersion
20222023-2302-16011.0 Draft

© 2022 Clinical 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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David Cella, PhD. owns the copyright for the FACT-G V4 instrument and has granted CDISC permission to include this supplement in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.

These materials discuss and/or include FACIT Measurement System, which is owned exclusively by Dr. David Cella. No part of the FACIT Measurement System may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of Dr. David Cella and payment of any applicable fees. Copyright Dr. David Cella. All rights reserved.

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

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CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond the normal license fees charged by the copyright holder.

CDISC acknowledges Dr. David Cella and FACIT.org, for the approval to include the FACT-G V4 in the CDISC data standards.

Reference for the FACT-G V4:

the instrument beyond the normal license fees charged by the copyright holder.

CDISC acknowledges Dr. David Cella and FACIT.org, for the approval to include the FACT-G V4 in the CDISC data standards.

Reference for the FACT-G V4:

  • Copyright 1987, 1997 David Cella, Ph.D
  • Copyright 1987, 1997 David Cella, Ph.D.
  • These materials discuss and/or include FACIT Measurement System, which is owned exclusively by Dr. David Cella. No part of the FACIT Measurement System may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of Dr. David Cella and payment of any applicable fees. Copyright Dr. David Cella. All rights reserved.


3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

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