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Title | Mini-Mental State Examination 2 Standard Version (MMSE-2 STANDARD VERSION) |
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CDISC Reference | Functional Test Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
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QRS Short Name | |
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QRS Permission Status | Approved |
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Team | CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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Supplement Version | 1.0 |
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Status | DRAFT
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Date | 20212022-0704-1914 |
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Notes | This 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
Date | Version |
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20212022-0704-1914 | 1.0 Draft |
© 2021 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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This document describes the CDISC implementation of the Mini-Mental State Examination 2 Standard Version (MMSE-2 STANDARD VERSION) instrument.
CDISC does did not modify this QRS instruments instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.
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Psychological Assessment Resources, Inc. (PAR) owns the copyright for the MMSE-2 STANDARD 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 developed FTTESTCD and FTTEST for each item based on the actual text on the functional test.
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The MMSE-2 STANDARD VERSION example below shows the terminology used to implement the instrument in the FT domain. This example shows the data for 2 subjects collected at the baseline visit for a MMSE-2 STANDARD VERSION instrument. The example uses CDISC controlled terminology for FTTESTCD, FTTEST, and FTCAT. All original results, matching the CRF item response text, are represented with preferred terminology inFTORRES. This result is then transformed into the represented as a standard numeric score inFTSTRESN and as a standard character representation of the standard numeric score inFTSTRESC.
The table represents the questions from the MMSEthe 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 at the scheduled visit.
Dataset wrap |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | FTSEQ | FTTESTCD | FTTEST | FTCAT | FTSCAT | FTORRES | FTSTRESC | FTSTRESN | FTSTAT | FTLOBXFL | VISITNUM | FTDTC |
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1 | STUDYX | FT | 2324-P0001 | 1 | MMS201A | MMS2-Repeat Word 1 | MMSE-2 STANDARD VERSION | REGISTRATION | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 2 | STUDYX | FT | 2324-P0001 | 2 | MMS201B | MMS2-Repeat Word 2 | MMSE-2 STANDARD VERSION | REGISTRATION | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 3 | STUDYX | FT | 2324-P0001 | 3 | MMS201C | MMS2-Repeat Word 3 | MMSE-2 STANDARD VERSION | REGISTRATION | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 4 | STUDYX | FT | 2324-P0001 | 4 | MMS202A | MMS2-What Is the Year | MMSE-2 STANDARD VERSION | ORIENTATION TO TIME | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 5 | STUDYX | FT | 2324-P0001 | 5 | MMS202B | MMS2-What Is the Season | MMSE-2 STANDARD VERSION | ORIENTATION TO TIME | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 6 | STUDYX | FT | 2324-P0001 | 6 | MMS202C | MMS2-What Is the Month of Year | MMSE-2 STANDARD VERSION | ORIENTATION TO TIME | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 7 | STUDYX | FT | 2324-P0001 | 7 | MMS202D | MMS2-What Is the Day of Week | MMSE-2 STANDARD VERSION | ORIENTATION TO TIME | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 8 | STUDYX | FT | 2324-P0001 | 8 | MMS202E | MMS2-What Is the Date | MMSE-2 STANDARD VERSION | ORIENTATION TO TIME | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 9 | STUDYX | FT | 2324-P0001 | 9 | MMS203A | MMS2-What Is the State | MMSE-2 STANDARD VERSION | ORIENTATION TO PLACE | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 10 | STUDYX | FT | 2324-P0001 | 10 | MMS203B | MMS2-What Is the County | MMSE-2 STANDARD VERSION | ORIENTATION TO PLACE | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 11 | STUDYX | FT | 2324-P0001 | 11 | MMS203C | MMS2-What Is the City/Town | MMSE-2 STANDARD VERSION | ORIENTATION TO PLACE | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 12 | STUDYX | FT | 2324-P0001 | 12 | MMS203D | MMS2-What Is the Building | MMSE-2 STANDARD VERSION | ORIENTATION TO PLACE | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 13 | STUDYX | FT | 2324-P0001 | 13 | MMS203E | MMS2-What Is the Floor | MMSE-2 STANDARD VERSION | ORIENTATION TO PLACE | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 14 | STUDYX | FT | 2324-P0001 | 14 | MMS204A | MMS2-Recall Word 1 | MMSE-2 STANDARD VERSION | RECALL | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 15 | STUDYX | FT | 2324-P0001 | 15 | MMS204B | MMS2-Recall Word 2 | MMSE-2 STANDARD VERSION | RECALL | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 16 | STUDYX | FT | 2324-P0001 | 16 | MMS204C | MMS2-Recall Word 3 | MMSE-2 STANDARD VERSION | RECALL | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 17 | STUDYX | FT | 2324-P0001 | 17 | MMS205A | MMS2-What is 100 Take Away 7 | MMSE-2 STANDARD VERSION | ATTENTION AND CALCULATION | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 18 | STUDYX | FT | 2324-P0001 | 18 | MMS205B | MMS2-Keep Subtracting 7 Step 2 | MMSE-2 STANDARD VERSION | ATTENTION AND CALCULATION | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 19 | STUDYX | FT | 2324-P0001 | 19 | MMS205C | MMS2-Keep Subtracting 7 Step 3 | MMSE-2 STANDARD VERSION | ATTENTION AND CALCULATION | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 20 | STUDYX | FT | 2324-P0001 | 20 | MMS205D | MMS2-Keep Subtracting 7 Step 4 | MMSE-2 STANDARD VERSION | ATTENTION AND CALCULATION | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 21 | STUDYX | FT | 2324-P0001 | 21 | MMS205E | MMS2-Keep Subtracting 7 Step 5 | MMSE-2 STANDARD VERSION | ATTENTION AND CALCULATION | INCORRECT | 0 | 0 |
| Y | 1 | 2015-05-15 | 22 | STUDYX | FT | 2324-P0001 | 22 | MMS206A | MMS2-Naming Object 1 | MMSE-2 STANDARD VERSION | NAMING | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 23 | STUDYX | FT | 2324-P0001 | 23 | MMS206B | MMS2-Naming Object 2 | MMSE-2 STANDARD VERSION | NAMING | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 24 | STUDYX | FT | 2324-P0001 | 24 | MMS207 | MMS2-Repeat What I Say | MMSE-2 STANDARD VERSION | REPETITION | INCORRECT | 0 | 0 |
| Y | 1 | 2015-05-15 | 25 | STUDYX | FT | 2324-P0001 | 25 | MMS208A | MMS2-Point to the Circle | MMSE-2 STANDARD VERSION | COMPREHENSION | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 26 | STUDYX | FT | 2324-P0001 | 26 | MMS208B | MMS2-Point to the Square | MMSE-2 STANDARD VERSION | COMPREHENSION | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 27 | STUDYX | FT | 2324-P0001 | 27 | MMS208C | MMS2-Point to the Triangle | MMSE-2 STANDARD VERSION | COMPREHENSION | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 28 | STUDYX | FT | 2324-P0001 | 28 | MMS209 | MMS2- Do What This Says to Do | MMSE-2 STANDARD VERSION | READING | INCORRECT | 0 | 0 |
| Y | 1 | 2015-05-15 | 29 | STUDYX | FT | 2324-P0001 | 29 | MMS210 | MMS2-Write a Sentence | MMSE-2 STANDARD VERSION | WRITING | CORRECT | 1 | 1 |
| Y | 1 | 2015-05-15 | 30 | STUDYX | FT | 2324-P0001 | 30 | MMS211 | MMS2-Copy This Design | MMSE-2 STANDARD VERSION | DRAWING | INCORRECT | 0 | 0 |
| Y | 1 | 2015-05-15 | 31 | STUDYX | FT | 2324-P0001 | 31 | MMS212 | MMS2-BV Total Raw Score | MMSE-2 STANDARD VERSION |
| 16 | 16 | 16 |
| Y | 1 | 2015-05-15 | 32 | STUDYX | FT | 2324-P0001 | 32 | MMS213 | MMS2-SV Total Raw Score | MMSE-2 STANDARD VERSION |
| 26 | 26 | 26 |
| Y | 1 | 2015-05-15 | 33 | STUDYX | FT | 2324-P0001 | 33 | MMS214 | MMS2-Level of Consciousness | MMSE-2 STANDARD VERSION |
| Alert/Responsive | Alert/Responsive |
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| Y | 1 | 2015-05-15 | 34 | STUDYX | FT | 2324-P0002 | 1 | MMS201A | MMS2-Repeat Word 1 | MMSE-2 STANDARD VERSION | REGISTRATION |
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| NOT DONE |
| 1 | 2015-05-15 | 35 | STUDYX | FT | 2324-P0002 | 2 | MMS201B | MMS2-Repeat Word 2 | MMSE-2 STANDARD VERSION | REGISTRATION |
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| NOT DONE |
| 1 | 2015-05-15 | 36 | STUDYX | FT | 2324-P0002 | 3 | MMS201C | MMS2-Repeat Word 3 | MMSE-2 STANDARD VERSION | REGISTRATION |
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| NOT DONE |
| 1 | 2015-05-15 | 37 | STUDYX | FT | 2324-P0002 | 4 | MMS202A | MMS2-What Is the Year | MMSE-2 STANDARD VERSION | ORIENTATION TO TIME |
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| NOT DONE |
| 1 | 2015-05-15 | 38 | STUDYX | FT | 2324-P0002 | 5 | MMS202B | MMS2-What Is the Season | MMSE-2 STANDARD VERSION | ORIENTATION TO TIME |
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| NOT DONE |
| 1 | 2015-05-15 | 39 | STUDYX | FT | 2324-P0002 | 6 | MMS202C | MMS2-What Is the Month of Year | MMSE-2 STANDARD VERSION | ORIENTATION TO TIME |
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| NOT DONE |
| 1 | 2015-05-15 | 40 | STUDYX | FT | 2324-P0002 | 7 | MMS202D | MMS2-What Is the Day of Week | MMSE-2 STANDARD VERSION | ORIENTATION TO TIME |
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| NOT DONE |
| 1 | 2015-05-15 | 41 | STUDYX | FT | 2324-P0002 | 8 | MMS202E | MMS2-What Is the Date | MMSE-2 STANDARD VERSION | ORIENTATION TO TIME |
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| NOT DONE |
| 1 | 2015-05-15 | 42 | STUDYX | FT | 2324-P0002 | 9 | MMS203A | MMS2-What Is the State | MMSE-2 STANDARD VERSION | ORIENTATION TO PLACE |
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| NOT DONE |
| 1 | 2015-05-15 | 43 | STUDYX | FT | 2324-P0002 | 10 | MMS203B | MMS2-What Is the County | MMSE-2 STANDARD VERSION | ORIENTATION TO PLACE |
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| NOT DONE |
| 1 | 2015-05-15 | 44 | STUDYX | FT | 2324-P0002 | 11 | MMS203C | MMS2-What Is the City/Town | MMSE-2 STANDARD VERSION | ORIENTATION TO PLACE |
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| NOT DONE |
| 1 | 2015-05-15 | 45 | STUDYX | FT | 2324-P0002 | 12 | MMS203D | MMS2-What Is the Building | MMSE-2 STANDARD VERSION | ORIENTATION TO PLACE |
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| NOT DONE |
| 1 | 2015-05-15 | 46 | STUDYX | FT | 2324-P0002 | 13 | MMS203E | MMS2-What Is the Floor | MMSE-2 STANDARD VERSION | ORIENTATION TO PLACE |
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| NOT DONE |
| 1 | 2015-05-15 | 47 | STUDYX | FT | 2324-P0002 | 14 | MMS204A | MMS2-Recall Word 1 | MMSE-2 STANDARD VERSION | RECALL |
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| NOT DONE |
| 1 | 2015-05-15 | 48 | STUDYX | FT | 2324-P0002 | 15 | MMS204B | MMS2-Recall Word 2 | MMSE-2 STANDARD VERSION | RECALL |
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| NOT DONE |
| 1 | 2015-05-15 | 49 | STUDYX | FT | 2324-P0002 | 16 | MMS204C | MMS2-Recall Word 3 | MMSE-2 STANDARD VERSION | RECALL |
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| NOT DONE |
| 1 | 2015-05-15 | 50 | STUDYX | FT | 2324-P0002 | 17 | MMS205A | MMS2-What is 100 Take Away 7 | MMSE-2 STANDARD VERSION | ATTENTION AND CALCULATION |
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| NOT DONE |
| 1 | 2015-05-15 | 51 | STUDYX | FT | 2324-P0002 | 18 | MMS205B | MMS2-Keep Subtracting 7 Step 2 | MMSE-2 STANDARD VERSION | ATTENTION AND CALCULATION |
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| NOT DONE |
| 1 | 2015-05-15 | 52 | STUDYX | FT | 2324-P0002 | 19 | MMS205C | MMS2-Keep Subtracting 7 Step 3 | MMSE-2 STANDARD VERSION | ATTENTION AND CALCULATION |
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| NOT DONE |
| 1 | 2015-05-15 | 53 | STUDYX | FT | 2324-P0002 | 20 | MMS205D | MMS2-Keep Subtracting 7 Step 4 | MMSE-2 STANDARD VERSION | ATTENTION AND CALCULATION |
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| NOT DONE |
| 1 | 2015-05-15 | 54 | STUDYX | FT | 2324-P0002 | 21 | MMS205E | MMS2-Keep Subtracting 7 Step 5 | MMSE-2 STANDARD VERSION | ATTENTION AND CALCULATION |
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| NOT DONE |
| 1 | 2015-05-15 | 55 | STUDYX | FT | 2324-P0002 | 22 | MMS206A | MMS2-Naming Object 1 | MMSE-2 STANDARD VERSION | NAMING |
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| NOT DONE |
| 1 | 2015-05-15 | 56 | STUDYX | FT | 2324-P0002 | 23 | MMS206B | MMS2-Naming Object 2 | MMSE-2 STANDARD VERSION | NAMING |
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| NOT DONE |
| 1 | 2015-05-15 | 57 | STUDYX | FT | 2324-P0002 | 24 | MMS207 | MMS2-Repeat What I Say | MMSE-2 STANDARD VERSION | REPETITION |
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| NOT DONE |
| 1 | 2015-05-15 | 58 | STUDYX | FT | 2324-P0002 | 25 | MMS208A | MMS2-Point to the Circle | MMSE-2 STANDARD VERSION | COMPREHENSION |
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| NOT DONE |
| 1 | 2015-05-15 | 59 | STUDYX | FT | 2324-P0002 | 26 | MMS208B | MMS2-Point to the Square | MMSE-2 STANDARD VERSION | COMPREHENSION |
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| NOT DONE |
| 1 | 2015-05-15 | 60 | STUDYX | FT | 2324-P0002 | 27 | MMS208C | MMS2-Point to the Triangle | MMSE-2 STANDARD VERSION | COMPREHENSION |
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| NOT DONE |
| 1 | 2015-05-15 | 61 | STUDYX | FT | 2324-P0002 | 28 | MMS209 | MMS2- Do What This Says to Do | MMSE-2 STANDARD VERSION | READING |
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| NOT DONE |
| 1 | 2015-05-15 | 62 | STUDYX | FT | 2324-P0002 | 29 | MMS210 | MMS2-Write a Sentence | MMSE-2 STANDARD VERSION | WRITING |
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| NOT DONE |
| 1 | 2015-05-15 | 63 | STUDYX | FT | 2324-P0002 | 30 | MMS211 | MMS2-Copy This Design | MMSE-2 STANDARD VERSION | DRAWING |
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| NOT DONE |
| 1 | 2015-05-15 | 64 | STUDYX | FT | 2324-P0002 | 31 | MMS212 | MMS2-BV Total Raw Score | MMSE-2 STANDARD VERSION |
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| NOT DONE |
| 1 | 2015-05-15 | 65 | STUDYX | FT | 2324-P0002 | 32 | MMS213 | MMS2-SV Total Raw Score | MMSE-2 STANDARD VERSION |
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| NOT DONE |
| 1 | 2015-05-15 | 66 | STUDYX | FT | 2324-P0002 | 33 | MMS214 | MMS2-Level of Consciousness | MMSE-2 STANDARD VERSION |
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| NOT DONE |
| 1 | 2015-05-15 |
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