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Revision History

© 2020 2021 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Functional Tests (FT) domain model, which can be found at the CDISC website at: ( https://www.cdisc.org/standards/foundational/sdtmig).

These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC web site at: ( https://www.cdisc.org/standards/foundational/qrs).

The CDISC Intellectual Property Policy can be found on the CDISC web site at: (https://www.cdisc.org/about/bylaws).

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

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Psychological Assessment Resources, Inc. (PAR) owns  owns the copyright for the MMSEthe MMSE-2 STANDARD VERSION instrument VERSION instrument and has granted CDISC permission to include this supplement in the CDISC library of QRS data standards supplements. PAR will distribute the CDISC supplement package to sponsors when they are approved to use this instrument. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the functional test.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) case report form(s) annotated with the CDISC SDTMIG variables with submission values. 

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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 MMSE-2 STANDARD VERSION, 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-2 STANDARD VERSION instrument includes a brief version total score and a standard version total score that are considered as captured data on the CRF and are 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 questions from the MMSE-2 STANDARD VERSION instrument. Rows 31 and 32 show the brief and standard total raw scores for USUBJID = "2324-P0001". USUBJID="2324-P0002" did not perform the MMSEthe MMSE-2 STANDARD VERSION.

4 SDTM Mapping Strategy

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