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For the TIG Product Impact on Individual Health use case, assumptions in this section will be used with:

TOBA-634 - Getting issue details... STATUS

NumRecord or Variable PopulationImplementation
1 Instrument name

Names of instruments, represented in --CAT, may be either abbreviations or longer names. Applicants will reference CDISC Controlled Terminology: 

  • The list of QRS instruments that have published CDISC Controlled Terminology with NCI/EVS are available at: https://www.cdisc.org/standards/terminology/controlled-terminology.  TOBA-524 - Getting issue details... STATUS
  • Refer to the following CDISC Controlled Terminology codelists for QRS instrument --CAT terminology:
    • Category of Clinical Classification
    • Category of Functional Test
    • Category of Questionnaire
  • QRS --TESTCD/--TEST terminology codelists are listed separately by instrument name.       
2Subcategories 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.

3Numeric standardized responses

When numeric standardized responses assigned to text responses (e.g., a numeric standardized response of 0 assigned to response RARELY) 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. TOBA-633 - Getting issue details... STATUS This is irrespective of data collection (e.g., when a QRS CRF does not include numeric standardized responses for collected text).

4Derived 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.

  • QRS subtotal, total, etc. scores listed on the CRF are considered captured data and are included in the instrument’s controlled terminology.
  • QRS subtotal, total, etc. scores not listed on the CRF but documented in an associated instrument manual or reference paper are considered captured data and are included in the instrument’s controlled terminology.
  • QRS subtotal, total, etc. scores not listed on the CRF, but known to be included in eData by applicants are considered captured data and are included in the instrument’s controlled terminology. The QRS instrument’s controlled terminology is considered extensible for this case and the subtotal or total score should be requested to be added.
    • Any imputations/calculations done to numeric “standardized responses” to produce the total score via transforming numeric “standardized responses” are done as part of analysis.
  • The QRS instrument subtotal or total score, which is the sum of the numeric responses for an instrument, is populated in --ORRES, --STRESC, and --STRESN. It is considered a captured subtotal or total score without any knowledge of the applicant data management processes related to the score.
    • If operationally derived by the applicant, it is the applicant's responsibility to set the --DRVFL flag based on their eCRF process to derive subtotal and total scores. An investigator-derived score written on a CRF will be considered a captured score and not flagged. When subtotal and total scores are derived by the applicant, the derived flag (--DRVFL) is set to "Y". However, when the subtotal and total scores are received from a central provider or vendor, the value would go into --ORRES and --DRVFL would be null.
5Multiple repeats of a question

The variable --REPNUM 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.

6Evaluator

If needed, evaluators may be represented in SUPP-- datasets and variables --EVAL and --EVALID will not be used. 

7Allowable 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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