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The scale points include a numeric rating (0-1) and a description of what is represented by the rating (e.g., 0 = "INCORRECT", 1 = "CORRECT"). For the Serial 7s and WORLD questions,
the numeric rating is 0-5Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-625
, andJira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-626
. For the MMSE, FTORRES is populated with the text description of "INCORRECT" or "CORRECT". The numeric rating is represented in FTSTRESC and FTSTRESN. The actual result answers to each question are not represented in the dataset; only whether the answer is "CORRECT" or "INCORRECT" is represented.Jira server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-628 The MMSE instrument includes subtotal
and total scores that are considered as captured data on the CRF 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 the CRF.Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-629 Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-630 If operationally defined by the sponsor, it is the sponsor's responsibility to set the --DRVFL flag based on their eCRF process to derive subtotal and total scores. An investigator derived score will be considered a captured score and not flagged. When subtotal and total scores are derived by the sponsor, 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 (See SDTMIG Section 4.1.8.1, Origin Metadata for Variables).
Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-631 - If scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM.
- Terminology:
FTCAT, FTTESTCD, and FTTEST values are included in CDISC controlled terminology.
A full list of value sets for result field is provided in Section 4, SDTM Mapping Strategy.
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