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1 Introduction

This document describes the CDISC implementation of the Title instrument.

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The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

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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.  (Include this line only for supplements that the US FDA will be reviewing.  Please DO NOT MODIFY the sentence.)

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 for the QRS Short_Name 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) 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.

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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 QRS Short_Name are listed below.

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1. Include a description of scale score or other possible responses (You may need multiple numbered points for this, though the IDS-SR did not.). For scale scores use the following language: The scale points include a numeric rating (0-3) and a definition of what is represented by the rating (e.g., 0 = "I never take longer than 30 minutes to fall asleep"). For the QRS Short_Name, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN. (Replace this sentence for instruments with text only responses with “QSORRES and QSSTRESC are populated with the text description and QSSTRESN is not represented with a numeric value”.

2. Include a description of the evaluation interval if one exists. This may be numeric (QSEVLINT) or text (QSEVINTX). When the evaluation interval is provided in text and cannot be described in ISO 8601 format, use QSEVINTX instead of "QSEVLINT field in ISO 8601 format" and replace "the past 7 days" with the text (e.g., "DAYTIME'". Refer to SDTMIG Section 2.2.5 Timing Variables for All Classes). The evaluation interval needs to be clearly defined on the CRF. Remove this point if it does not apply.: 

   1. If numeric use this wording: The time period of evaluation for theQRS Short_Name is populated in the --EVLINTfield in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the QRS Short_Name is the past 7 days (--EVLINT = "-P7D"). 

   2. If text use this wording: The time period of evaluation for the QRS Short_Name is populated in the --EVINTX field as an evaluation interval text value, since it cannot be precisely described as an ISO 8601 duration. The evaluation interval for the QRS Short_Name is "LIFETIME" (--EVINTX = "LIFETIME").
3. If there are subcategories, include a note that subcategories will be represented in QSSCAT. Also provide a list of the subcategories unless one is already provided in the description preceding the assumptions. Remove this point if it does not apply.  For example:  Items are divided into 5 subcategories represented in QSSCAT: "PHYSICAL WELL-BEING", "SOCIAL/FAMILY WELL-BEING", "EMOTIONAL WELL-BEING", "FUNCTIONAL WELL-BEING", and "ADDITIONAL CONCERNS".

4. Records are created in qs.xpt for every instrument item: 

   1. For items with no data, QSORRES, QSSTRESC, and QSSTRESN are all missing and QSSTAT = "NOT DONE". If the reason is known then that reason is represented in QSREASND (e.g., QSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then QSSTAT = "NOT DONE" and QSREASND is missing.

   2. Due to the variability of copyright holder and public domain derived score generation processes, records are not included for derived subscores or total scores that are not provided.

5. If the instrument standards currently being developed includes conditionally branched items, insert: Some items on the QRS Short_Name may be conditionally branched per the instrument instructions. Only one of the 2 oxygen saturation scales (RSTESTCD = "NEWS102" or "NEWS103") is completed for each subject. The other will be treated as a conditionally branched item. In addition, item RSTESTCD = "NEWS104A" is only completed when the response to RSTESTCD = "NEWS104" is the amount of oxygen received (in L/min). A record is created in rs.xpt for all items. When an item is considered a conditionally branched item, it is represented as follows:

   When assigned with conditionally branched responses are not documented in the instrument’s instructions or a user manual:

   1. QNAM = “QSCBRFL”, QLABEL = “Conditional Branched Item Flag“, QVAL = “Y” (this is a QS supplemental qualifier variable related to the record).
   2. QSORRES, QSSTRESC, and QSSTRESN are set to null (missing).

   When assigned conditionally branched responses are documented in instructions or a user manual:

   1. QNAM = “QSCBRFL”, QLABEL = “Conditional Branched Item Flag“, QVAL = “Y” (this is a QS supplemental qualifier variable).
   2. The QSORRES responses are represented as follows:
   1. For severity items, QSORRES = "None".
   2. For interference items, QSORRES = "Not at all".
   3. If numeric response values are assigned, they are represented here: QSSTRESC = 0 and QSSTRESN = 0.

      or if no numeric responses are assigned: QSSTRESC = NULL and QSSTRESN = NULL.

6. Include this point if score(s) are submitted to SDTM. Update blue text: The QRS Short_Name instrument includes a total score (and subscores or other scores as needed.  If so, change "that is" to "that are") that is considered as captured data on the instrument and is not considered as derived in the example below. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from [Insert copyright holder's name or other source.].

   1. Subtotal and total scores are represented in--ORRES, --STRESC, and --STRESN.
   2. If scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible. It is the sponsors repsonsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.

7. Please review the decision on not including –EVAL and --EVALID in the QRS Supplement Best Practices topic “--EVAL/–EVALID not included in QRS domains/datasets”.Now we only represent administrative information if it is explicitly collected on an instrument. No assumptions are made for this data; if it's not on the instrument, it's not in the data.

   The SUPPQUAL variables used are a series of non-standard variables that represent collected administrator information, administration device, etc., and these updated SUPPQUAL variables are included in the WIKI non-standard variable registry (Non-standard Variable Registry). For example:

   1. PPRAID which is "Preprinted Administrator Identifier".
   2. COLAVL which is "Collected Administrator Value".

   The supplement version 1.0 of the FAS-NACC UDS V3.0 instrument shows an implementation example.

   The QRS Short_Name instrument collects administrative information as the preprinted examiner’s initials and the collected response. This is represented in the SUPPQUAL variable QNAM = --PPRAID” with QNAM = “Preprinted Administrator Identifier” and QVAL = “EXAMINER’S INITIALS”. The collected initials response is represented with QNAM = “--COLAID” and QNAM = “Collected Administrator Identifier” and QVAL = “ADM1”.

   This is part of the data example for the SUPPQUAL variables.

   The SUPPRS table represents the preprinted and collected administrative items represented on the CRF. 

    supprs.xpt

   STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
   STUDYX	RS	100-10001	RSCAT	FAS-NACC UDS V3.0	RSPPRAID	Preprinted Administrator Identifier	EXAMINER'S INITIALS	CRF
   STUDYX	RS	100-10001	RSCAT	FAS-NACC UDS V3.0	RSCOLAID	Collected Administrator Identifier	ADM1	CRF

8. Include this point if there are comments at the end of the instrument. Remove this point if it does not apply.: Comments located at the end of the QRS Short_Name will be recorded in the Comments domain (CO). All assumptions and business rules described in the SDTMIG CO domain are applicable.

9. Include this point if there are responses over 200 characters. Remove this point if it does not apply: Some responses to the QRS Short_Name items exceeded the 200-character limit for the QSORRES variable and needed to be reduced to fewer than 200 characters. Section 4, SDTM Mapping Strategy, indicates which item responses were revised in order to fit the 200-character limit.
   

10. Terminology

    1. QSCAT, QSTESTCD, QSTEST, QSORRES, QSSTRESC, and QSSTRESN (and other variables such as QSORRESU as needed; only include QSORRES, QSSTRESC, and QSSTRESN if the responses are published in CT with public domains instruments) values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the qualifier, timing, result, and unit fields is provided in Section 4, SDTM Mapping Strategy. (Note: Only the result field is always used. Include qualifier, timing, and unit fields as needed and remove this note.)

3.2 Example for the QRS Short_Name QS Domain Model

The QRS Short_Name example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at the baseline visit for the QRS Short_Name instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results, matching the CRF item response text, are represented in QSORRES. When there are numeric results, then use this sentence next, "This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC." When the results are character only, then use these sentences next, "This result is then transformed into the standard character representation in QSSTRESC. QSSTRESN is null as there are no standardized numeric results for this instrument."

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4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

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