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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

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 McMaster University owns the copyright for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION instrument and has granted CDISC permission to include this supplement in the CDISC inventory 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) McMaster University will distribute the CDISC supplement package to sponsors when they are approved to use this instrument.) Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.

For public domain instruments use the following text: CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION 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. There may be many versions of this instrument. 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/controlled-terminology.

Reference for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION:

Rush, A.J., Carmody, T. and Reimitz, P.E. The Inventory of Depressive Symptomatology (IDS): Clinician (IDS-C) and self-report (IDS-SR) ratings of depressive symptoms. International Journal of Methods in Psychiatric Research, 9:45-59, 2000. 

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This is an example only.  Use the reference from the CDISC definition of the QSCAT.

• do not include the parentheses.
• do not include copyright information from the definition about copyright holder and version since that's already included above.
• do add a period to the end. 

If there are multiple references, please use the following format:

References for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION:

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/controlled-terminology.

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 acknowledgesDr. Gordon H. Guyatt, Dept. of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada for the approval to include the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION in the CDISC data standards.

Reference for the CRQ-SAS FOLLOW-UP ADMINISTRATION VERSION:

• The Chronic Respiratory Questionnaire Self-Administered including the standardized Dyspnea Domain (CRQSAS), Principal authors G.H. Guyatt and Dr. H.J. Schunemann, is the copyright of McMaster University.
• http://milo.mcmaster.ca/questionnaires/questionnaires
• http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2845220/
• http://www.proqolid.org/instruments/chronic_respiratory_disease_questionnaire_self_administered_standardized_crq_sas
• Schunemann HJ, Griffith L, Jaeschke R, Goldstein R, Stubbing D, Austin P, Guyatt GH. A comparison of the original chronic respiratory questionnaire with a standardized version. Chest. 2003 Oct;124(4):1421-9

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