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Title	Mini-Mental State Examination (MMSE)
CDISC Reference	Functional Test Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name	MMSE
QRS Permission Status	Approved
Team	CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version	1.0
Status	DRAFT
Date	20212022-0704-1914
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
20212022-0704-1914	1.0 Draft

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This document describes the CDISC implementation of the Mini-Mental State Examination (MMSE) instrument.

CDISC does did not modify this questionnaires, ratings, and scales (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 instrument MMSE instrument and has granted CDISC permission to include this supplement in the CDISC library inventory 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 example below shows the terminology used to implement the instrument in the FT domain. This example shows the data for 3 subjects collected at the baseline visit for the MMSE 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 items, subtotal and total scores from the MMSE instrument. USUBJID = "2324-P0001" performed the serial 7s portion of the MMSE. USUBJID = "2324-P0002" refused the 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.

Dataset wrap

Name	ft

Dataset2

Row	STUDYID	DOMAIN	USUBJID	FTSEQ	FTTESTCD	FTTEST	FTCAT	FTSCAT	FTORRES	FTSTRESC	FTSTRESN	FTSTAT	FTREASND	FTLOBXFL	VISITNUM	FTDTC
1	STUDYX	FT	2324-P0001	1	MMS101A	MMS1-What Is the Year	MMSE	ORIENTATION TO TIME	CORRECT	1	1			Y	1	2015-05-15
2	STUDYX	FT	2324-P0001	2	MMS101B	MMS1-What Is the Season	MMSE	ORIENTATION TO TIME	CORRECT	1	1			Y	1	2015-05-15
3	STUDYX	FT	2324-P0001	3	MMS101C	MMS1-What Is the Month of Year	MMSE	ORIENTATION TO TIME	CORRECT	1	1			Y	1	2015-05-15
4	STUDYX	FT	2324-P0001	4	MMS101D	MMS1-What Is the Day of Week	MMSE	ORIENTATION TO TIME	CORRECT	1	1			Y	1	2015-05-15
5	STUDYX	FT	2324-P0001	5	MMS101E	MMS1-What Is the Date	MMSE	ORIENTATION TO TIME	CORRECT	1	1			Y	1	2015-05-15
6	STUDYX	FT	2324-P0001	6	MMS102A	MMS1-What Is the State	MMSE	ORIENTATION TO PLACE	CORRECT	1	1			Y	1	2015-05-15
7	STUDYX	FT	2324-P0001	7	MMS102B	MMS1-What Is the County	MMSE	ORIENTATION TO PLACE	CORRECT	1	1			Y	1	2015-05-15
8	STUDYX	FT	2324-P0001	8	MMS102C	MMS1-What Is the City/Town	MMSE	ORIENTATION TO PLACE	CORRECT	1	1			Y	1	2015-05-15
9	STUDYX	FT	2324-P0001	9	MMS102D	MMS1-What Is the Building	MMSE	ORIENTATION TO PLACE	CORRECT	1	1			Y	1	2015-05-15
10	STUDYX	FT	2324-P0001	10	MMS102E	MMS1-What Is the Floor	MMSE	ORIENTATION TO PLACE	CORRECT	1	1			Y	1	2015-05-15
11	STUDYX	FT	2324-P0001	11	MMS103A	MMS1-Repeat Word 1	MMSE	REGISTRATION	CORRECT	1	1			Y	1	2015-05-15
12	STUDYX	FT	2324-P0001	12	MMS103B	MMS1-Repeat Word 2	MMSE	REGISTRATION	CORRECT	1	1			Y	1	2015-05-15
13	STUDYX	FT	2324-P0001	13	MMS103C	MMS1-Repeat Word 3	MMSE	REGISTRATION	CORRECT	1	1			Y	1	2015-05-15
14	STUDYX	FT	2324-P0001	14	MMS104AA	MMS1-What is 100 Take Away 7	MMSE	ATTENTION AND CALCULATION	CORRECT	1	1			Y	1	2015-05-15
15	STUDYX	FT	2324-P0001	15	MMS104AB	MMS1-Keep Subtracting 7 Step 2	MMSE	ATTENTION AND CALCULATION	CORRECT	1	1			Y	1	2015-05-15
16	STUDYX	FT	2324-P0001	16	MMS104AC	MMS1-Keep Subtracting Step 3	MMSE	ATTENTION AND CALCULATION	CORRECT	1	1			Y	1	2015-05-15
17	STUDYX	FT	2324-P0001	17	MMS104AD	MMS1-Keep Subtracting Step 4	MMSE	ATTENTION AND CALCULATION	INCORRECT	0	0			Y	1	2015-05-15
18	STUDYX	FT	2324-P0001	18	MMS104AE	MMS1-Keep Subtracting Step 5	MMSE	ATTENTION AND CALCULATION	INCORRECT	0	0			Y	1	2015-05-15
19	STUDYX	FT	2324-P0001	19	MMS104BA	MMS1-Spell Backward Letter 1	MMSE	ATTENTION AND CALCULATION				NOT DONE	LOGICALLY SKIPPED ITEM	Y	1	2015-05-15
20	STUDYX	FT	2324-P0001	20	MMS104BB	MMS1-Spell Backward Letter 2	MMSE	ATTENTION AND CALCULATION				NOT DONE	LOGICALLY SKIPPED ITEM	Y	1	2015-05-15
21	STUDYX	FT	2324-P0001	21	MMS104BC	MMS1-Spell Backward Letter 3	MMSE	ATTENTION AND CALCULATION				NOT DONE	LOGICALLY SKIPPED ITEM	Y	1	2015-05-15
22	STUDYX	FT	2324-P0001	22	MMS104BD	MMS1-Spell Backward Letter 4	MMSE	ATTENTION AND CALCULATION				NOT DONE	LOGICALLY SKIPPED ITEM	Y	1	2015-05-15
23	STUDYX	FT	2324-P0001	23	MMS104BE	MMS1-Spell Backward Letter 5	MMSE	ATTENTION AND CALCULATION				NOT DONE	LOGICALLY SKIPPED ITEM	Y	1	2015-05-15
24	STUDYX	FT	2324-P0001	24	MMS104	MMS1-Attention and Calculation Subtotal	MMSE	ATTENTION AND CALCULATION	3	3	3			Y	1	2015-05-15
25	STUDYX	FT	2324-P0001	25	MMS105A	MMS1-Recall Word 1	MMSE	RECALL	CORRECT	1	1			Y	1	2015-05-15
26	STUDYX	FT	2324-P0001	26	MMS105B	MMS1-Recall Word 2	MMSE	RECALL	CORRECT	1	1			Y	1	2015-05-15
27	STUDYX	FT	2324-P0001	27	MMS105C	MMS1-Recall Word 3	MMSE	RECALL	CORRECT	1	1			Y	1	2015-05-15
28	STUDYX	FT	2324-P0001	28	MMS106A	MMS1-Naming Object 1	MMSE	NAMING	CORRECT	1	1			Y	1	2015-05-15
29	STUDYX	FT	2324-P0001	29	MMS106B	MMS1-Naming Object 2	MMSE	NAMING	INCORRECT	0	0			Y	1	2015-05-15
30	STUDYX	FT	2324-P0001	30	MMS107	MMS1-Repeat What I Say	MMSE	REPETITION	CORRECT	1	1			Y	1	2015-05-15
31	STUDYX	FT	2324-P0001	31	MMS108A	MMS1-Take in Right Hand	MMSE	COMPREHENSION	CORRECT	1	1			Y	1	2015-05-15
32	STUDYX	FT	2324-P0001	32	MMS108B	MMS1-Fold in Half	MMSE	COMPREHENSION	CORRECT	1	1			Y	1	2015-05-15
33	STUDYX	FT	2324-P0001	33	MMS108C	MMS1-Put on Floor (or Table)	MMSE	COMPREHENSION	CORRECT	1	1			Y	1	2015-05-15
34	STUDYX	FT	2324-P0001	34	MMS109	MMS1-Read This and Do What It Says	MMSE	READING	INCORRECT	0	0			Y	1	2015-05-15
35	STUDYX	FT	2324-P0001	35	MMS110	MMS1-Write a Sentence	MMSE	WRITING	CORRECT	1	1			Y	1	2015-05-15
36	STUDYX	FT	2324-P0001	36	MMS111	MMS1-Copy This Design	MMSE	DRAWING	INCORRECT	0	0			Y	1	2015-05-15
37	STUDYX	FT	2324-P0001	37	MMS112	MMS1-Total Score	MMSE		25	25	25			Y	1	2015-05-15
38	STUDYX	FT	2324-P0001	38	MMS113	MMS1-Level of Consciousness	MMSE		Alert/Responsive	Alert/Responsive	.			Y	1	2015-05-15
39	STUDYX	FT	2324-P0002	1	MMS101A	MMS1-What Is the Year	MMSE	ORIENTATION TO TIME	CORRECT	1	1			Y	1	2015-05-15
40	STUDYX	FT	2324-P0002	2	MMS101B	MMS1-What Is the Season	MMSE	ORIENTATION TO TIME	CORRECT	1	1			Y	1	2015-05-15
41	STUDYX	FT	2324-P0002	3	MMS101C	MMS1-What Is the Month of Year	MMSE	ORIENTATION TO TIME	CORRECT	1	1			Y	1	2015-05-15
42	STUDYX	FT	2324-P0002	4	MMS101C	MMS1-What Is the Month of Year	MMSE	ORIENTATION TO TIME	CORRECT	1	1			Y	1	2015-05-15
43	STUDYX	FT	2324-P0002	5	MMS101D	MMS1-What Is the Day of Week	MMSE	ORIENTATION TO TIME	CORRECT	1	1			Y	1	2015-05-15
44	STUDYX	FT	2324-P0002	6	MMS101E	MMS1-What Is the Date	MMSE	ORIENTATION TO TIME	CORRECT	1	1			Y	1	2015-05-15
45	STUDYX	FT	2324-P0002	7	MMS102A	MMS1-What Is the State	MMSE	ORIENTATION TO PLACE	CORRECT	1	1			Y	1	2015-05-15
46	STUDYX	FT	2324-P0002	8	MMS102B	MMS1-What Is the County	MMSE	ORIENTATION TO PLACE	CORRECT	1	1			Y	1	2015-05-15
47	STUDYX	FT	2324-P0002	9	MMS102C	MMS1-What Is the City/Town	MMSE	ORIENTATION TO PLACE	CORRECT	1	1			Y	1	2015-05-15
48	STUDYX	FT	2324-P0002	10	MMS102D	MMS1-What Is the Building	MMSE	ORIENTATION TO PLACE	CORRECT	1	1			Y	1	2015-05-15
49	STUDYX	FT	2324-P0002	11	MMS102E	MMS1-What Is the Floor	MMSE	ORIENTATION TO PLACE	CORRECT	1	1			Y	1	2015-05-15
50	STUDYX	FT	2324-P0002	12	MMS103A	MMS1-Repeat Word 1	MMSE	REGISTRATION	CORRECT	1	1			Y	1	2015-05-15
51	STUDYX	FT	2324-P0002	13	MMS103B	MMS1-Repeat Word 2	MMSE	REGISTRATION	CORRECT	1	1			Y	1	2015-05-15
52	STUDYX	FT	2324-P0002	14	MMS103C	MMS1-Repeat Word 3	MMSE	REGISTRATION	CORRECT	1	1			Y	1	2015-05-15
53	STUDYX	FT	2324-P0002	15	MMS104AA	MMS1-What is 100 Take Away 7	MMSE	ATTENTION AND CALCULATION				NOT DONE	LOGICALLY SKIPPED ITEM	Y	1	2015-05-15
54	STUDYX	FT	2324-P0002	16	MMS104AB	MMS1-Keep Subtracting 7 Step 2	MMSE	ATTENTION AND CALCULATION				NOT DONE	LOGICALLY SKIPPED ITEM	Y	1	2015-05-15
55	STUDYX	FT	2324-P0002	17	MMS104AC	MMS1-Keep Subtracting Step 3	MMSE	ATTENTION AND CALCULATION				NOT DONE	LOGICALLY SKIPPED ITEM	Y	1	2015-05-15
56	STUDYX	FT	2324-P0002	18	MMS104AD	MMS1-Keep Subtracting Step 4	MMSE	ATTENTION AND CALCULATION				NOT DONE	LOGICALLY SKIPPED ITEM	Y	1	2015-05-15
57	STUDYX	FT	2324-P0002	19	MMS104AE	MMS1-Keep Subtracting Step 5	MMSE	ATTENTION AND CALCULATION				NOT DONE	LOGICALLY SKIPPED ITEM	Y	1	2015-05-15
58	STUDYX	FT	2324-P0002	20	MMS104BA	MMS1-Spell Backward Letter 1	MMSE	ATTENTION AND CALCULATION	CORRECT	1	1			Y	1	2015-05-15
59	STUDYX	FT	2324-P0002	21	MMS104BB	MMS1-Spell Backward Letter 2	MMSE	ATTENTION AND CALCULATION	CORRECT	1	1			Y	1	2015-05-15
60	STUDYX	FT	2324-P0002	22	MMS104BC	MMS1-Spell Backward Letter 3	MMSE	ATTENTION AND CALCULATION	INCORRECT	0	0			Y	1	2015-05-15
61	STUDYX	FT	2324-P0002	23	MMS104BD	MMS1-Spell Backward Letter 4	MMSE	ATTENTION AND CALCULATION	INCORRECT	0	0			Y	1	2015-05-15
62	STUDYX	FT	2324-P0002	24	MMS104BE	MMS1-Spell Backward Letter 5	MMSE	ATTENTION AND CALCULATION	CORRECT	1	1			Y	1	2015-05-15
63	STUDYX	FT	2324-P0002	25	MMS104	MMS1-Attention and Calculation Subtotal	MMSE	ATTENTION AND CALCULATION	3	3	3			Y	1	2015-05-15
64	STUDYX	FT	2324-P0002	26	MMS105A	MMS1-Recall Word 1	MMSE	RECALL	CORRECT	1	1			Y	1	2015-05-15
65	STUDYX	FT	2324-P0002	27	MMS105B	MMS1-Recall Word 2	MMSE	RECALL	CORRECT	1	1			Y	1	2015-05-15
66	STUDYX	FT	2324-P0002	28	MMS105C	MMS1-Recall Word 3	MMSE	RECALL	CORRECT	1	1			Y	1	2015-05-15
67	STUDYX	FT	2324-P0002	29	MMS106A	MMS1-Naming Object 1	MMSE	NAMING	CORRECT	1	1			Y	1	2015-05-15
68	STUDYX	FT	2324-P0002	30	MMS106B	MMS1-Naming Object 2	MMSE	NAMING	INCORRECT	0	0			Y	1	2015-05-15
69	STUDYX	FT	2324-P0002	31	MMS107	MMS1-Repeat What I Say	MMSE	REPETITION	CORRECT	1	1			Y	1	2015-05-15
70	STUDYX	FT	2324-P0002	32	MMS108A	MMS1-Take in Right Hand	MMSE	COMPREHENSION	CORRECT	1	1			Y	1	2015-05-15
71	STUDYX	FT	2324-P0002	33	MMS108B	MMS1-Fold in Half	MMSE	COMPREHENSION	CORRECT	1	1			Y	1	2015-05-15
72	STUDYX	FT	2324-P0002	34	MMS108C	MMS1-Put on Floor (or Table)	MMSE	COMPREHENSION	CORRECT	1	1			Y	1	2015-05-15
73	STUDYX	FT	2324-P0002	35	MMS109	MMS1-Read This and Do What It Says	MMSE	READING	INCORRECT	0	0			Y	1	2015-05-15
74	STUDYX	FT	2324-P0002	36	MMS110	MMS1-Write a Sentence	MMSE	WRITING	CORRECT	1	1			Y	1	2015-05-15
75	STUDYX	FT	2324-P0002	37	MMS111	MMS1-Copy This Design	MMSE	DRAWING	INCORRECT	0	0			Y	1	2015-05-15
76	STUDYX	FT	2324-P0002	38	MMS112	MMS1-Total Score	MMSE		26	26	26			Y	1	2015-05-15
77	STUDYX	FT	2324-P0002	39	MMS113	MMS1-Level of Consciousness	MMSE		Drowsy	Drowsy	.			Y	1	2015-05-15
78	STUDYX	FT	2324-P0003	1	MMS101A	MMS1-What Is the Year	MMSE	ORIENTATION TO TIME				NOT DONE			1	2015-05-15
79	STUDYX	FT	2324-P0003	2	MMS101B	MMS1-What Is the Season	MMSE	ORIENTATION TO TIME				NOT DONE			1	2015-05-15
80	STUDYX	FT	2324-P0003	3	MMS101C	MMS1-What Is the Month of Year	MMSE	ORIENTATION TO TIME				NOT DONE			1	2015-05-15
81	STUDYX	FT	2324-P0003	4	MMS101D	MMS1-What Is the Day of Week	MMSE	ORIENTATION TO TIME				NOT DONE			1	2015-05-15
82	STUDYX	FT	2324-P0003	5	MMS101E	MMS1-What Is the Date	MMSE	ORIENTATION TO TIME				NOT DONE			1	2015-05-15
83	STUDYX	FT	2324-P0003	6	MMS102A	MMS1-What Is the State	MMSE	ORIENTATION TO PLACE				NOT DONE			1	2015-05-15
84	STUDYX	FT	2324-P0003	7	MMS102B	MMS1-What Is the County	MMSE	ORIENTATION TO PLACE				NOT DONE			1	2015-05-15
85	STUDYX	FT	2324-P0003	8	MMS102C	MMS1-What Is the City/Town	MMSE	ORIENTATION TO PLACE				NOT DONE			1	2015-05-15
86	STUDYX	FT	2324-P0003	9	MMS102D	MMS1-What Is the Building	MMSE	ORIENTATION TO PLACE				NOT DONE			1	2015-05-15
87	STUDYX	FT	2324-P0003	10	MMS102E	MMS1-What Is the Floor	MMSE	ORIENTATION TO PLACE				NOT DONE			1	2015-05-15
88	STUDYX	FT	2324-P0003	11	MMS103A	MMS1-Repeat Word 1	MMSE	REGISTRATION				NOT DONE			1	2015-05-15
89	STUDYX	FT	2324-P0003	12	MMS103B	MMS1-Repeat Word 2	MMSE	REGISTRATION				NOT DONE			1	2015-05-15
90	STUDYX	FT	2324-P0003	13	MMS103C	MMS1-Repeat Word 3	MMSE	REGISTRATION				NOT DONE			1	2015-05-15
91	STUDYX	FT	2324-P0003	14	MMS104AA	MMS1-What is 100 Take Away 7	MMSE	ATTENTION AND CALCULATION				NOT DONE			1	2015-05-15
92	STUDYX	FT	2324-P0003	15	MMS104AB	MMS1-Keep Subtracting 7 Step 2	MMSE	ATTENTION AND CALCULATION				NOT DONE			1	2015-05-15
93	STUDYX	FT	2324-P0003	16	MMS104AC	MMS1-Keep Subtracting Step 3	MMSE	ATTENTION AND CALCULATION				NOT DONE			1	2015-05-15
94	STUDYX	FT	2324-P0003	17	MMS104AD	MMS1-Keep Subtracting Step 4	MMSE	ATTENTION AND CALCULATION				NOT DONE			1	2015-05-15
95	STUDYX	FT	2324-P0003	18	MMS104AE	MMS1-Keep Subtracting Step 5	MMSE	ATTENTION AND CALCULATION				NOT DONE			1	2015-05-15
96	STUDYX	FT	2324-P0003	19	MMS104BA	MMS1-Spell Backward Letter 1	MMSE	ATTENTION AND CALCULATION				NOT DONE			1	2015-05-15
97	STUDYX	FT	2324-P0003	20	MMS104BB	MMS1-Spell Backward Letter 2	MMSE	ATTENTION AND CALCULATION				NOT DONE			1	2015-05-15
98	STUDYX	FT	2324-P0003	21	MMS104BC	MMS1-Spell Backward Letter 3	MMSE	ATTENTION AND CALCULATION				NOT DONE			1	2015-05-15
99	STUDYX	FT	2324-P0003	22	MMS104BD	MMS1-Spell Backward Letter 4	MMSE	ATTENTION AND CALCULATION				NOT DONE			1	2015-05-15
100	STUDYX	FT	2324-P0003	23	MMS104BE	MMS1-Spell Backward Letter 5	MMSE	ATTENTION AND CALCULATION				NOT DONE			1	2015-05-15
101	STUDYX	FT	2324-P0003	24	MMS104	MMS1-Attention and Calculation Subtotal	MMSE	ATTENTION AND CALCULATION				NOT DONE			1	2015-05-15
102	STUDYX	FT	2324-P0003	25	MMS105A	MMS1-Recall Word 1	MMSE	RECALL				NOT DONE			1	2015-05-15
103	STUDYX	FT	2324-P0003	26	MMS105B	MMS1-Recall Word 2	MMSE	RECALL				NOT DONE			1	2015-05-15
104	STUDYX	FT	2324-P0003	27	MMS105C	MMS1-Recall Word 3	MMSE	RECALL				NOT DONE			1	2015-05-15
105	STUDYX	FT	2324-P0003	28	MMS106A	MMS1-Naming Object 1	MMSE	NAMING				NOT DONE			1	2015-05-15
106	STUDYX	FT	2324-P0003	29	MMS106B	MMS1-Naming Object 2	MMSE	NAMING				NOT DONE			1	2015-05-15
107	STUDYX	FT	2324-P0003	30	MMS107	MMS1-Repeat What I Say	MMSE	REPETITION				NOT DONE			1	2015-05-15
108	STUDYX	FT	2324-P0003	31	MMS108A	MMS1-Take in Right Hand	MMSE	COMPREHENSION				NOT DONE			1	2015-05-15
109	STUDYX	FT	2324-P0003	32	MMS108B	MMS1-Fold in Half	MMSE	COMPREHENSION				NOT DONE			1	2015-05-15
110	STUDYX	FT	2324-P0003	33	MMS108C	MMS1-Put on Floor (or Table)	MMSE	COMPREHENSION				NOT DONE			1	2015-05-15
111	STUDYX	FT	2324-P0003	34	MMS109	MMS1-Read This and Do What It Says	MMSE	READING				NOT DONE			1	2015-05-15
112	STUDYX	FT	2324-P0003	35	MMS110	MMS1-Write a Sentence	MMSE	WRITING				NOT DONE			1	2015-05-15
113	STUDYX	FT	2324-P0003	36	MMS111	MMS1-Copy This Design	MMSE	DRAWING				NOT DONE			1	2015-05-15
114	STUDYX	FT	2324-P0003	37	MMS112	MMS1-Total Score	MMSE					NOT DONE			1	2015-05-15
115	STUDYX	FT	2324-P0003	38	MMS113	MMS1-Level of Consciousness	MMSE					NOT DONE			1	2015-05-15

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