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Include this line only for supplements that the US FDA will be reviewing: 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.  

1.2   Copyright Status

(fyi, much of the text is in blue because not all instruments are public domain or copyrighted; however, please only change the name of the copyright holder and the QRS Short_Name and remove italics.)

For public domain instruments use the following text:  This instrument is CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the QRS Short_Name APACHE II in the CDISC library of QRS data standards supplements. There may be many versions of this instrument in the public domain or copyrighted. CDISC has chosen to use the version attached to the QRS supplement to the SDTMIG, and the QRS supplement to the ADaMIG is based on the same version.

For copyrighted instruments use the following text:  Name of copyright holder (e.g. Board of Regents of The University of Texas System) owns the copyright for the QRS Short_Name instrument and has granted CDISC permission to include this supplement in the CDISC library of QRS data standards supplements. (For supplements that are to be distributed by the copyright holder, add: Name of copyright holder (e.g. Board of Regents of The University of Texas System) will distribute the CDISC supplement package to sponsors when they are approved to use this instrument.) There may be many versions of this instrument in the public domain or copyrighted. CDISC has chosen to use the version attached to the QRS supplement to the SDTMIG, and the QRS supplement to the ADaMIG is based on the same version.

Only include for copyrighted instruments: CDISC acknowledges name of copyright holder (e.g., Drs. Robert L. Spitzer, Janet B.W. Williams, Kurt Kroenke and colleagues as developers of the GAD-7 and Pfizer) for the approval to include the QRS Short_Name in the CDISC data standards.

Only include for copyrighted instruments: 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. 

Include for all instruments: Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent versions of the SDTM and ADaM controlled terminologies should be accessed through the CDISC website (https://www.cdisc.org/standards/terminology).

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