- Created by Christine Connolly, last modified on Mar 19, 2023
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For the TIG Product Impact on Individual Health use case, assumptions in this section will be used with:
- CDISC QRS Supplements for specific instruments referred to in Section x.x, About Questionnaires, Ratings, and Scales.
- Domain-specific assumptions for domains, QS, FT, and RS.
Num | Record or Variable Population | Implementation |
---|---|---|
1 | Instrument Name | The name of an instrument is represented --CAT and may be either abbreviations or longer names. Applicants will reference CDISC Controlled Terminology:
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2 | Subcategories for Groups of Items/Questions | Names of subcategories for groups of items/questions are described under the --SCAT variable. --SCAT values are not included in the CDISC Controlled Terminology system but rather controlled as described in the QRS supplements in which they are used. |
3 | Numeric Standardized Responses | When numeric standardized responses assigned to text responses (e.g., mild, moderate, severe being 1, 2, 3) are documented in the QRS CRF instructions, a user manual, a website specific to the QRS instrument, or another reference document, the numeric responses will be represented in the tabulation dataset. This is irrespective of data collection (e.g., when a QRS CRF does not include numeric standardized responses for collected text). |
4 | Derived Records for Results | Applicants will consult published QRS supplements for guidance on submitting derived information in a QRS domain. Derived variable results in QRS are usually considered captured data. If applicants operationally derive variable results in a new record, then this will be represented in --DRVFL. The following rules apply for “total”-type scores in QRS datasets.
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5 | Multiple Repeats of a Question | The variable --REPNUM variable is populated when there are multiple repeats of the same question. When records are related to the first trial of the question, the variable --REPNUM should be set to "1". When records are related to the second trial of the same question, --REPNUM should be set to "2", and so forth. |
6 | Instrument Version Number | The actual version number of an instrument is represented in the --CAT value as designated by the QRS Terminology Team. If it is determined that this is not the case for an instrument:
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7 | If the variable --TEST is represented with verbatim text >40 characters, represent the abbreviated meaningful text in --TEST within 40 characters and describe the full text of the item in the study metadata. If the verbatim item response (e.g., --QSORRES) is >200 characters, represent the abbreviated meaningful text in QSORRES within the 200 characters and describe the full text in the study metadata; see Section 4 of the QRS supplement. See Section 4.5.3, Text Strings that Exceed the Maximum Length for General Observation-class Domain Variables, for further information.
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8 | Evaluator | If needed, evaluators may be represented in SUPP-- datasets and variables --EVAL and --EVALID will not be used. |
9 | Allowable Variables | Any identifiers, timing variables, or findings general observation class qualifiers may be added to a QRS domain, but the following qualifiers would generally not be used: --POS, --BODSYS, --ORNRLO, --ORNRHI, --STNRLO, --STNRHI, --STRNC, --NRIND, --XFN, --LOINC, --SPEC, --SPCCND, --LOC, --FAST, --TOX, --TOXGR, --SEV. |
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