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Title

Mini-Mental State Examination 2 Standard Version (MMSE-2 STANDARD VERSION)

CDISC ReferenceFunctional Test Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

MMSE-2 STANDARD VERSION

QRS Permission StatusApproved
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date2022-04-1430
NotesThis supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.


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Revision History

DateVersion
2022-04-14301.0 Draft

© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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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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