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1.  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 Serial 7s and WORLD questions, the numeric rating is 0-5, and the sub-score subscore for these questions is represented where FTTESTCD = "MMS104". 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.
   

2. 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.

   1. 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).

   2. If scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM.
3. Terminology:
   

   1. FTCAT, FTTESTCD, and FTTEST values are included in CDISC controlled terminology.

   2. A full list of value sets for result field is provided in Section 4, SDTM Mapping Strategy.

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The table represents the items, subtotal, subtotal and and total scores from the MMSE instrument. USUBJID = "2324-P0001" performed the serial Serial 7s portion of the MMSE. USUBJID = "2324-P0002" refused the serial Serial 7s portion of the MMSE but performed the WORLD spelled backwards portion instead. USUBJID="2324-P0003" did not perform the MMSE at the scheduled visit.

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This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM FT domain. It also provides guidance on how the subcategories (FTSCAT) and the result variables (FTORRES, FTSTRESC, and FTSTRESN) should be populated.

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