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titleInstructions on how to use this template

  1. Replace royal blue text with information pertaining to the instrument the supplement is being created for. Delete royal blue text which does not apply to the new instrument.
  2. Unless otherwise noted, text in black applies to all QRS Supplements and should not be deleted
  3. Remove all information blocks, except for the one immediately below this called 'Information for Reviewers'.
  4. Keep changes in blue for ease throughout internal and public review. Once the supplement has gone thru public review and all comments are resolved, change all text color to black except for hyperlinks.
  5. Arabic numerals (0, 1, 2, 3, etc.)are used to express numbers in most circumstances. Exceptions are the following: 
    • Numbers that begin a sentence, title, subtitle, or heading 

    • Common fractions 

    • Accepted usage such as idiomatic expressions and numbers used as pronouns 

    • Other uses of “one” in running text (e.g., when meaning "a")
    • Ordinals first through ninth
    • Numbers spelled out in quotes or published titles.
  6. ******ITEMS IN RED: Needs to be discussed with Steve/Dana.*******
Info
titleInformation for Reviewers

Text in black is part of the template used to create this document and is not under review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

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  1. The scale points include a numeric rating (1-7) and a definition of what is represented by the rating (e.g., 1 = "All of the time"). For the CRQ-SAS FIRST ADMINISTRATION VERSION, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.a.  The first 5 questions have a questionnaire choice of “8 = Not Done”. The result of “8” is included in QSSTRESC and QSSTRESN; however, the sponsor’s analysis plan should determine whether this value is considered a score for purposes of summary statistic calculations.

  2. The time period of evaluation for theCRQ-SAS FIRST ADMINISTRATION VERSION is populated in the --EVLINTfield in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the CRQ-SAS FIRST ADMINISTRATION VERSION is the LAST 2 WEEKS (QSEVLINT = "-P2W"). 

  3. Records are created in qs.xpt for every item on the instrument: 

    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.

  4. Terminology

    1. QSCAT, QSTESTCD, and QSTEST 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 CRQ-SAS FIRST ADMINISTRATION VERSION QS Domain Model

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Dataset wrap
Nameqs
Rowcaps
Rows 21-40:Show the subject 2324-P0002 was not evaluated on this instrument. Since the visit was missed, the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred.
Dataset2
RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSORRESQSSTRESCQSSTRESNQSSTATQSLOBXFLVISITNUMQSDTCQSEVLINT
1STUDYXQS2324-P00011CRQ0101CRQ01-Feeling EmotionalCRQ-SAS FIRST ADMINISTRATION VERSIONExtremely short of breath11
Y12022-05-15-P2W
2STUDYXQS2324-P00012CRQ0102CRQ01-Take Care of Basic NeedsCRQ-SAS FIRST ADMINISTRATION VERSIONVery short of breath22
Y12022-05-15-P2W
3STUDYXQS2324-P00013CRQ0103CRQ01-WalkingCRQ-SAS FIRST ADMINISTRATION VERSIONModerate shortness of breath44
Y12022-05-15-P2W
4STUDYXQS2324-P00014CRQ0104CRQ01-Performing ChoresCRQ-SAS FIRST ADMINISTRATION VERSIONNot at all short of breath77
Y12022-05-15-P2W
5STUDYXQS2324-P00015CRQ0105CRQ01-Participate in Social ActivitiesCRQ-SAS FIRST ADMINISTRATION VERSIONNot Done88
Y12022-05-15-P2W
6STUDYXQS2324-P00016CRQ0106CRQ01-Felt Frustrated or ImpatientCRQ-SAS FIRST ADMINISTRATION VERSIONA good bit of the time33
Y12022-05-15-P2W
7STUDYXQS2324-P00017CRQ0107CRQ01-Feeling of Fear or PanicCRQ-SAS FIRST ADMINISTRATION VERSIONSome of the time44
Y12022-05-15-P2W
8STUDYXQS2324-P00018CRQ0108CRQ01-FatigueCRQ-SAS FIRST ADMINISTRATION VERSIONExtremely tired11
Y12022-05-15-P2W
9STUDYXQS2324-P00019CRQ0109CRQ01-Embarrassed by CoughingCRQ-SAS FIRST ADMINISTRATION VERSIONA little of the time55
Y12022-05-15-P2W
10STUDYXQS2324-P000110CRQ0110CRQ01-Confident to Deal With IllnessCRQ-SAS FIRST ADMINISTRATION VERSIONA little of the time22
Y12022-05-15-P2W
11STUDYXQS2324-P000111CRQ0111CRQ01-EnergyCRQ-SAS FIRST ADMINISTRATION VERSIONFull of energy77
Y12022-05-15-P2W
12STUDYXQS2324-P000112CRQ0112CRQ01-Feel Upset, Worried or DepressedCRQ-SAS FIRST ADMINISTRATION VERSIONHardly any of the time66
Y12022-05-15-P2W
13STUDYXQS2324-P000113CRQ0113CRQ01-Control of Breathing ProblemsCRQ-SAS FIRST ADMINISTRATION VERSIONMost of the time55
Y12022-05-15-P2W
14STUDYXQS2324-P000114CRQ0114CRQ01-Feel Relaxed and Free of TensionCRQ-SAS FIRST ADMINISTRATION VERSIONA good bit of the time44
Y12022-05-15-P2W
15STUDYXQS2324-P000115CRQ0115CRQ01-Felt Low in EnergyCRQ-SAS FIRST ADMINISTRATION VERSIONA good bit of the time33
Y12022-05-15-P2W
16STUDYXQS2324-P000116CRQ0116CRQ01-Felt Discouraged or DownCRQ-SAS FIRST ADMINISTRATION VERSIONMost of the time22
Y12022-05-15-P2W
17STUDYXQS2324-P000117CRQ0117CRQ01-Felt Worn Out or SluggishCRQ-SAS FIRST ADMINISTRATION VERSIONAll of the time11
Y12022-05-15-P2W
18STUDYXQS2324-P000118CRQ0118CRQ01-Happy, Satisfied or PleasedCRQ-SAS FIRST ADMINISTRATION VERSIONHappy most of the time55
Y12022-05-15-P2W
19STUDYXQS2324-P000119CRQ0119CRQ01-Feel Upset Diff Getting BreathCRQ-SAS FIRST ADMINISTRATION VERSIONMost of the time22
Y12022-05-15-P2W
20STUDYXQS2324-P000120CRQ0120CRQ01-Felt Restless, Tense or UptightCRQ-SAS FIRST ADMINISTRATION VERSIONSome of the time44
Y12022-05-15-P2W
21STUDYXQS2324-P000221CRQ0101CRQ01-Feeling EmotionalCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
22STUDYXQS2324-P000222CRQ0102CRQ01-Take Care of Basic NeedsCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
23STUDYXQS2324-P000223CRQ0103CRQ01-WalkingCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
24STUDYXQS2324-P000224CRQ0104CRQ01-Performing ChoresCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
25STUDYXQS2324-P000225CRQ0105CRQ01-Participate in Social ActivitiesCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
26STUDYXQS2324-P000226CRQ0106CRQ01-Felt Frustrated or ImpatientCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
27STUDYXQS2324-P000227CRQ0107CRQ01-Feeling of Fear or PanicCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
28STUDYXQS2324-P000228CRQ0108CRQ01-FatigueCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
29STUDYXQS2324-P000229CRQ0109CRQ01-Embarrassed by CoughingCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
30STUDYXQS2324-P000230CRQ0110CRQ01-Confident to Deal With IllnessCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
31STUDYXQS2324-P000231CRQ0111CRQ01-EnergyCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
32STUDYXQS2324-P000232CRQ0112CRQ01-Feel Upset, Worried or DepressedCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
33STUDYXQS2324-P000233CRQ0113CRQ01-Control of Breathing ProblemsCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
34STUDYXQS2324-P000234CRQ0114CRQ01-Feel Relaxed and Free of TensionCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
35STUDYXQS2324-P000235CRQ0115CRQ01-Felt Low in EnergyCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
36STUDYXQS2324-P000236CRQ0116CRQ01-Felt Discouraged or DownCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
37STUDYXQS2324-P000237CRQ0117CRQ01-Felt Worn Out or SluggishCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
38STUDYXQS2324-P000238CRQ0118CRQ01-Happy, Satisfied or PleasedCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
39STUDYXQS2324-P000239CRQ0119CRQ01-Feel Upset Diff Getting BreathCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
40STUDYXQS2324-P000240CRQ0120CRQ01-Felt Restless, Tense or UptightCRQ-SAS FIRST ADMINISTRATION VERSION


NOT DONE
1
-P2W
Info

The following is for illustrative purposes and would not really be included for the IDS-SR instrument in this template. It provides an example of what would need to be included if the instrument required supplemental qualifiers (see Section 5 Supplemental Qualifier Name Codes):

Text that would remain unchanged has been left in black:

The evaluation interval text value for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.

CRF
Dataset wrap
Namesuppqs
STUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG
STUDYXQSP0001QSSEQSequence number corresponding to row of qs.xpt that supplemental qualifier is needed for (e.g., 8)Appropriate variable name to provide more information about data in qs.xpt, no more than 8 characters long (e.g., CONTACT).Label for QNAM (e.g., Contact Type)Value of QNAM variable ( e.g., SUBJECT VISIT)


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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