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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. Copyright 1987, 1997 David Cella, Ph.D.

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 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.

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the FACT-HG G V4 are listed below.

The FACT-G V4 is a multiple-choice health-related general quality of life questionnaire about problems associated with cancer. It consists of 27 items rated on a 5-point scale.

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