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The representation of data collected for this functional test 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 functional test 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/foundational/qrs).
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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 (MMSE-2 STANDARD VERSION v1 Annotated CRF 2019-05-31.pdf). .
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title | Information for Reviewers |
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The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF. |
Note: CDISC controlled terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website (https://www.cdisc.org/standards/terminology).
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CDISC acknowledges R. Bob Smith III, PhD, Chairman and CEO Psychological Assessment Resources, Inc. for the approval to implement the MMSE-2 STANDARD VERSION as CDISC data standard.
Reference for the Mini MMSE-Mental State Examination 2 Standard Version (MMSE-2 STANDARD VERSION)2 STANDARD VERSION:
Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12(3):189‒198.
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The table represents the questions from the MMSE-2 STANDARD VERSION form. Rows 31 and 32 show the brief and standard total raw scores for USUBJID = "2324-P0001". USUBJID="2324-P0002" did not perform the MMSE.
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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 | 01 |
| 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 | 01 |
| 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 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 | Y | 1 | 2015-05-15 |
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4 SDTM Mapping Strategy
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 result variables (FTORRES, FTSTRESC and FTSTRESN) should be populated.
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