| Num | Record or Variable Population | Implementation |
|---|
| 1 | Instrument |
NameThe name of an instrument is represented Names of instruments, represented in --CAT |
and , 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.
- 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.
| | 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 |
There are cases where QRS CRFs do not include numeric “standardized responses” assigned to text responses (e.g., mild, moderate, severe being 1, 2, 3). It is clearly in everyone's best interest to include the numeric “standardized responses” in the SDTMIG QRS dataset. This is only done when the numeric “standardized responses” are documented in the | Numeric standardized responses | When text responses have assigned standardized numeric responses, both the text and numeric responses will be represented in the tabulation dataset using variables --ORRES and --STRESC/--STRESN respectively. Assigned numeric responses are those documented in instrument specific documentation, such as QRS CRF instructions, a user manual, and/or a website specific to the QRS instrument |
, or another reference document that provides a clear explanation and rationale for providing them in the SDTMIG QRS 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 |
4 | Sponsors should always consult published QRS supplements for guidance on submitting derived information in a |
SDTMIG QRS domain. Derived variable |
results in results in QRS are usually considered captured data. If |
sponsors applicants operationally derive variable results in a new record, then |
the derived records that are submitted in a QRS domain should be flagged by 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
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sponsors - applicants are considered
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as , - and are included in the instrument’s controlled terminology. The QRS instrument’s
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CT - 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”
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in any way would be ADaM derivations- 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
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sponsor-- applicant data management processes related to the score.
- If operationally derived by the
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sponsor sponsor- 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
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sponsor- 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
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(see Section 41.8.1, Origin Metadata for Variables). | | 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 |
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: - Notify the QRS Terminology Team that the instrument has a specific or multiple version numbers. This team will assist in providing an resolution on how the situation will be handled.
- Consider the use of the --GRPID variable to indicate the instrument's version number prior to a decision by the QRS Terminology Team.
- The sponsor is expected to provide information about the version used for each QRS instrument in the metadata (using the Comments column in the Define-XML document). This could be provided as value-level metadata for --CAT.
- The sponsor is expected to provide information about the scoring rules in the metadata.
| 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. - The instrument’s annotated CRF can also be used as a reference for the full text in both of these situations.
| 8 | | Evaluator | If needed, evaluators may be represented in SUPP-- datasets and variables --EVAL and --EVALID |
must to model QRS data in SDTM These variables have had various interpretations on QRS CRFs and were used to represent a multitude of evaluator information about QRS instruments. This has made it more difficult for users of SDTM QRS data to interpret this data and more difficult to pool data for analyses. If needed, supplemental qualifiers may be used to represent this data. Updated information on a proposed solution to this issue will be posted on the CDISC QRS webpage (https://www.cdisc.org/standards/foundational/qrs). All standard QRS supplement development is coordinated with the CDISC SDS QRS Subteam as the governing body. The process involves drafting the controlled terminology and defining instrument-specific standardized values for qualifier, timing, and result variables to populate the SDTMIG FT, QS, and RS domains. These supplements are developed based on user demand and therapeutic area standards development needs. Sponsors should always consult the CDISC website to review the terminology and supplements prior to modeling any QRS instrument. Sponsors may participate and/or request the development of additional QRS supplements and terminology through the CDISC SDS QRS subteam and the Controlled Terminology QRS subteam.Once generated, the QRS supplement is posted on the CDISC website (https://www.cdisc.org/standards/foundational/qrs).Sponsors should always consult the published QRS supplements for guidance on submitting derived information in SDTMIG-based domains. | 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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