Post on 25-May-2018
CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )
© 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved
ADAS-Cog Questionnaire Supplement to the Study Data
Tabulation Model Implementation Guide
Prepared by the
Coalition Against Major Diseases (CAMD)
Notes to Readers This implementation guide follows version 3.1.2 (V3.1.2) of the CDISC Submission Data Standards and domain models.
Revision History
Date Version Summary of Changes 2011-09-09 1.0 Draft Alzheimer’s Disease Assessment Scale-
Cognitive (ADAS-Cog) Questionnaire 2011-12-27 1.0 Alzheimer’s Disease Assessment Scale-
Cognitive (ADAS-Cog) Questionnaire release 2012-01-26 1.0 Alzheimer’s Disease Assessment Scale-
Cognitive (ADAS-Cog) Questionnaire release revised with inclusion of copyright appendix
Note: Please see 1570HAppendix F for Representations and Warranties, Limitations of Liability, and Disclaimers.
CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )
Page 2 © 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved January 26, 2011
CONTENTS
6 DOMAIN MODELS BASED ON THE GENERAL OBSERVATION CL ASSES ............. 3
6.3 FINDINGS ......................................................................................................................................................... 3
6.3.5 Questionnaire — QS Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-Cog) ..................... 3
6.3.5.1 Assumptions for Questionnaire Domain Model .................................................................................... 3 6.3.5.2 Examples for Alzheimer ‘s Disease ASSESSMENT SCALE Questionnaire Domain Model ............... 4
APPENDICES ............................................................................................................... 13
Appendix 2: Mapping Strategy for SDTM Variables .............................................................................................. 14
Appendix 3: SUPPLEMENTAL Qualifiers Name Codes ........................................................................................ 20
Appendix F: Representations and Warranties, Limitations of Liability, and Disclaimers ...................................... 21
CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )
© 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 3 January 26, 2011
6 Domain Models Based on the General Observation Classes
6.3 FINDINGS
6.3.5 QUESTIONNAIRE — QS ALZHEIMER’S DISEASE ASSESS MENT SCALE – COGNITIVE (ADAS-COG)
See SDTMIG for QS domain table.
The documentation for this questionnaire is located on the CDISC website in the Members Only Section. The link is: http://www.cdisc.org/contentmgr/showdetails.php/id/2909. All questionnaire documentation is being stored together in a separate location because many questionnaires are utilized across many different disease areas. The CDISC Questionnaire Terminology Team is in the process of assessing copyright issues and developing controlled terminology for additional questionnaires. This site will be updated on a regular basis with new questionnaires. .
CDISC acknowledges Dr. Richard Mohs for his agreement to include the ADAS-Cog scale in the CDISC data standards. Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64.
6.3.5.1 ASSUMPTIONS FOR QUESTIONNAIRE DOMAIN MODEL
All assumptions for the QS domain from the SDTMIG apply for this supplemental implementation guide including those referenced in the CDISC notes. Additionally, the following assumptions apply to Alzheimer’s disease Assessment Scale – Cognitive. 1. Alzheimer’s Disease Assessment Scale – Cognitive (ADAS-Cog): ADAS-Cog is a standard clinical scale used in Alzheimer’s disease studies. ADAS-Cog scale has been implemented in a number of different methods. The most common implementation is to collect a subset of the 15 summary questions. A certified reviewer provides the scores based on a worksheet which contains all the detailed information recorded in the sub-items. In this approach the sub-item scores are not recorded. The certified reviewer enters the summary scores on the CRF/eCRF. In this case QSDRVFL is NULL. Another approach is to collect the detailed results which include individual sub-items that are used to derive the summary questions. This includes the results of individual trials of specific questions within the ADAS-Cog scale. Summary scores are derived by the sponsor via the detailed questions. In this case QSDRVFL is set to Y for the derived summary record.
CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )
Page 4 © 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved January 26, 2011
The ADAS-Cog example below shows the correct terminology for QSCAT, QSSCAT, QSTEST, QSTESTCD and QSORRES that should be utilized for this scale. Values for QSORRES are for prospective data collection. Sponsors mapping legacy data may retain legacy values for QSORRES.
2. The ADAS-Cog scale collects the reason why specific questions were not completed. The sponsor specifc terminology for the reason the question was not answered are condensed to be either ”Cognitive reasons” or ”Non-Cognitive reasons” as part of the ADAS-Cog data standard. The following table indicates how the QSSTAT and QSREASND fields are populated when the detailed questions are captured and the summary questions are derived.
Based on SDTM rules for these fields, the QSORRES field is blank when QSSTAT=Y or a result is derived (SDTMIG page 47). In the ADAS-Cog scale, when the summary question is “NOT DONE” for “Cognitive reasons”, the derived score is populated with the worse value (.ex “5”) as follows: QSORRES=NULL QSSTRESC=5 QSSTRESN=5 QSDRVFL=Y QSSTAT=NULL QSREASND=NULL. If the NOT DONE reason is “Non-Cognitive reasons”, a missing value (.ex “NULL”) is derived as follows: QSORRES=NULL QSSTRESC=NULL QSSTRESN=NULL QSDRVFL=Y QSSTAT=NULL QSREASND=NULL. This logic indicates that it is not the derivation that is “NOT DONE”; but it the underlying detailed questions used as the source data for the derivation that were “NOT DONE”. Those detail records would be marked as NOT DONE as follows: QSORRES=NULL QSSTRESC=NULL QSSTRESN=NULL QSDRVFL=NULL QSSTAT=NOT DONE QSREASND=”Cognitive reasons” or “Non-Cognitive reasons”. The interpretation of these derived summary question results is based on the detailed question results. For derived summary questions with QSSTRESN=5 or NULL, the interpretation of the not done result is based on the QSSTAT and QSREASND values of the detailed questions results. When the ADAS-Cog data is collected by a certified reviewer, who enters the summary question results, the population of QSSTAT and QSREASND is handled as follows QSORRES=NULL QSSTRESC=5 QSSTRESN=5 QSDRVFL=NULL QSSTAT=NOT DONE QSREASND=Cognitive reasons or QSORRES=NULL QSSTRESC=NULL QSSTRESN=NULL QSDRVFL=NULL QSSTAT=NOT DONE QSREASND=Non-Cognitive reasons. 3. QS ADAS-Cog specific mapping strategy for the following fields is listed in Appendix 1.
a. QSTPT, QSTPTNUM, QSORRES, QSSTRESC and QSSTRESN
6.3.5.2 EXAMPLES FOR ALZHEIMER ‘S DISEASE ASSESSMEN T SCALE QUESTIONNAIRE DOMAIN MODEL
Example 1: Alzheimer’s disease Assessment Scale –Cognitive (ADAS-Cog)
CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )
© 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 5 January 26, 2011
This example shows data from two subjects collected at one visit for an ADAS-Cog questionnaire with the detailed questions collected and the the summary question derived. The example uses standard controlled terminology for QSSPID, QSTESTCD, QSTEST, QSCAT and QSSCAT for the ADAS-Cog scale. Summary rows are shaded and detailed rows are not shaded. In order to show the concepts and for ease of use in review not all of the detailed rows are shown; these rows have “…” in them. For example, rows 4-11 are represented by one row and use the “…” notation. In these rows, STUDYID, DOMAIN, USUBJID, QSCAT, and QSSCAT do not change with regards to row 3. However, QSSEQ, QSSPID, QSTESTCD, and QSTEST with “…” all increment by 1 following the same naming convention as the previous value. QSORRES and QSTRESC would be populated with the actual data. The variables STUDYID=STUDYX, DOMAIN=QS and QSSTRESN are not shown in the example due to page width limitations. Rows 1, 35, 53, 59, 70, 76, 82, 91, 167-172, 176: Represent the 15 possible summary questions from the ADAS-Cog Form. All original results are represented with the
standard terminology in QSORRES. This result is then transformed into a Standard Numeric score from 0-5 in QSSTRESN, which is then also copied to a standard character value in QSSTRESC. All summary scores can either be entered by a certified evaluator or they can be derived via the detailed questions for each summary score. When derived, QSDRVLFL is set to “Y”.
Rows 2-12, 13-23, 24-34: Represent the 3 possible “Word Recall” trials. Rows 2, 13 and 24 represent the individual trial score with the 10 rows after each of these questions representing the individual words recalled either as correct or incorrect. Notice that QSTPTNUM and QSTPT are used to distinguish each of the three possible trials being asked on the same date where no time was collected. For more information on time points, see SDTMIG V3.1.2, Section 4.1.4.10.
Rows 35-52: Represent the “Naming Objects and Fingers” summary and detailed questions. Row 35 is the summary score for the detailed questions 36-52 on each object or finger.
Rows 53-58: Represent the “Commands” summary and detailed questions. Row 53 is the summary score for the detailed questions 54-58 on each command.
Rows 59-69: Represent the “Delayed Word Recall” summary and detailed questions. Row 59 is the summary score for the detailed questions 60-69 on each word presented to the subject for recall.
Rows 70-75: Represent the “Constructional Praxis” summary and detailed questions. Row 70 is the summary score for the detailed questions 71-75 on each “Constructional Praxis” object.
Rows 76-81: Represent the “Ideation Praxis” summary and detailed questions. Row 76 is the summary score for the detailed questions 77-81 on each Constructional Praxis object.
Rows 82-90: Represent the “Orientation summary” and detailed questions. Row 82 is the summary score for the detailed questions 83-90 on each Orientation location.
Rows 91-116, 117-141, 142-166: Represent the 3 possible “Word Recognition” trials. Rows 92, 117 and 142 represent the individual trial scores with each of
the 24 rows after each of these questions representing the individual words recognized either as correct or incorrect. Notice that QSTPTNUM and QSTPT are used to distinguish each of the three possible trials being asked on the same date where no time was collected. For more information on time points, see SDTMIG V3.1.2, Section 4.1.4.10.
Row 167: Represents the “Remembering Test Instructions” QSTEST name. Row 168: Represents the “Spoken Language Ability” QSTEST name. Row 169: Represents the “Word Finding Difficulty in Spont Speech” QSTEST name. Row 170: Represents the “Comprehension” QSTEST name. Row 171: Represents the “Concentration/Distractibility” QSTEST name.
CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )
Page 6 © 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved January 26, 2011
Rows 172-175: Represent the “Number Cancellation” summary and detailed QSTEST names. Row 172 is the summary score for the detailed questions 173-175 on each “Number Cancellation” question.
Rows 176-178: Represent the “Executive Function Maze” summary and detailed questions. Row 176 is the summary score for the detailed questions 177-178 on each “Executive Function Maze” question
Rows 179-191 Represents the use of the NOT DONE status for Cognitive reasons for subject 2324-P0002 for the Word Recall detail and summary questions.
Rows 192-200 Represents the use of the NOT DONE status for Cognitive reasons for subject 2324-P0002 for the Naming Objects and Fingers detail and summary questions.
qs.xpt Row USUBJID QSSEQ QSSPID QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSDRVFL QSSTAT QSREASND QSTPT QSTPTNUM
1 2324-P0001 1 01 ADCRL Word Recall ADAS-COG WORD
RECALL SUMMARY
2 2 Y
2 2324-P0001 2 01T1 ADCRLT01 Word Recall
Trial 1 ADAS-COG
WORD RECALL DETAIL
2 Words Not Recalled
2 Y
Trial 1 1
3 2324-P0001 3 01T1W01 ADCRLW01 Word Recall:
Word [1] ADAS-COG
WORD RECALL DETAIL
RECALLED RECALLED
Trial 1 1
… 2324-P0001 … … … … ADAS-COG WORD
RECALL DETAIL
… …
Trial 1 1
12 2324-P0001 12 01T1W10 ADCRLW10 Word Recall:
Word [10] ADAS-COG
WORD RECALL DETAIL
NOT RECALLED
NOT RECALLED
Trial 1 1
13 2324-P0001 13 01T2 ADCRLT02 Word Recall
Trial2 ADAS-COG
WORD RECALL DETAIL
2 Words Not Recalled
2 Y
Trial 2 2
14 2324-P0001 14 01T2W01 ADCRLW01 Word Recall:
Word [1] ADAS-COG
WORD RECALL DETAIL
RECALLED RECALLED
Trial 2 2
… 2324-P0001 … … … … ADAS-COG WORD
RECALL DETAIL
… …
Trial 2 2
23 2324-P0001 23 01T2W10 ADCRLW10 Word Recall:
Word [10] ADAS-COG
WORD RECALL DETAIL
NOT RECALLED
NOT RECALLED
Trial 2 2
24 2324-P0001 24 01T3 ADCRLT03 Word Recall
Trial 3 ADAS-COG
WORD RECALL DETAIL
2 Words Not Recalled
2 Y
Trial 3 3
25 2324-P0001 25 01T3W01 ADCRLW01 Word Recall:
Word [1] ADAS-COG
WORD RECALL DETAIL
RECALLED RECALLED
Trial 3 3
… 2324-P0001 … … … … ADAS-COG WORD
RECALL DETAIL
… …
Trial 3 3
CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )
© 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 7 January 26, 2011
Row USUBJID QSSEQ QSSPID QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSDRVFL QSSTAT QSREASND QSTPT QSTPTNUM
34 2324-P0001 34 01T3W10 ADCRLW10 Word Recall:
Word [10] ADAS-COG
WORD RECALL DETAIL
NOT RECALLED
NOT RECALLED
Trial 3 3
35 2324-P0001 35 02 ADCOF Naming Objects
and Fingers ADAS-COG
NAMING OBJECTS AND
FINGERS SUMMARY
0-2 items incorrect
0 Y
36 2324-P0001 36 02A ADCOFO01 Naming Objects and Fingers: 1
ADAS-COG
NAMING OBJECTS AND
FINGERS DETAIL
CORRECT CORRECT
… 2324-P0001 … … … … … … … … … …
47 2324-P0001 47 02L ADCOFO12 Naming Objects and Fingers: 12
ADAS-COG
NAMING OBJECTS AND
FINGERS DETAIL
CORRECT CORRECT
48 2324-P0001 48 02M ADCOFF01 Naming Objects
and Fingers: Thumb
ADAS-COG
NAMING OBJECTS AND
FINGERS DETAIL
CORRECT CORRECT
49 2324-P0001 49 02N ADCOFF02 Naming Objects
and Fingers: Pointer
ADAS-COG
NAMING OBJECTS AND
FINGERS DETAIL
CORRECT CORRECT
50 2324-P0001 50 02O ADCOFF03 Naming Objects
and Fingers: Middle
ADAS-COG
NAMING OBJECTS AND
FINGERS DETAIL
CORRECT CORRECT
51 2324-P0001 51 02P ADCOFF04 Naming Objects
and Fingers: Ring
ADAS-COG
NAMING OBJECTS AND
FINGERS DETAIL
INCORRECT INCORRECT
52 2324-P0001 52 02Q ADCOFF05 Naming Objects
and Fingers: Pinky
ADAS-COG
NAMING OBJECTS AND
FINGERS DETAIL
INCORRECT INCORRECT
53 2324-P0001 53 03 ADCCMD Commands ADAS-COG COMMANDS SUMMARY
5 Commands Correct
0 Y
54 2324-P0001 54 03A ADCCMD01 Commands: Fist ADAS-COG COMMANDS
DETAIL CORRECT CORRECT
55 2324-P0001 55 03B ADCCMD02 Commands:
Ceiling ADAS-COG
COMMANDS DETAIL
CORRECT CORRECT
56 2324-P0001 56 03C ADCCMD03 Commands:
Pencil ADAS-COG
COMMANDS DETAIL
CORRECT CORRECT
57 2324-P0001 57 03D ADCCMD04 Commands:
Watch ADAS-COG
COMMANDS DETAIL
CORRECT CORRECT
58 2324-P0001 58 03E ADCCMD05 Commands:
Shoulder ADAS-COG
COMMANDS DETAIL
CORRECT CORRECT
CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )
Page 8 © 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved January 26, 2011
Row USUBJID QSSEQ QSSPID QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSDRVFL QSSTAT QSREASND QSTPT QSTPTNUM
59 2324-P0001 59 04 ADCDRL Delayed Word
Recall ADAS-COG
DELAYED WORD
RECALL SUMMARY
10 Words Not Recalled
10 Y
60 2324-P0001 60 0401 ADCDRL01 Delayed Word
Recall: Word [1] ADAS-COG
DELAYED WORD
RECALL DETAIL
INCORRECT INCORRECT
… 2324-P0001 … … … … … … … … … …
69 2324-P0001 69 0410 ADCDRL10 Delayed Word Recall: Word
[10] ADAS-COG
DELAYED WORD
RECALL DETAIL
INCORRECT INCORRECT
70 2324-P0001 70 05 ADCCP Constructional
Praxis ADAS-COG
CONSTRUCTIONAL PRAXIS SUMMARY
1 form drawn incorrectly
1 Y
71 2324-P0001 71 05A ADCCP01 Constructional Praxis: Circle
ADAS-COG CONSTRUCTIO
NAL PRAXIS DETAIL
INCORRECT INCORRECT
72 2324-P0001 72 05B ADCCP02 Constructional
Praxis: 2 Rectangles
ADAS-COG CONSTRUCTIO
NAL PRAXIS DETAIL
CORRECT CORRECT
73 2324-P0001 73 05C ADCCP03 Constructional
Praxis: Diamond ADAS-COG
CONSTRUCTIONAL PRAXIS
DETAIL CORRECT CORRECT
74 2324-P0001 74 05D ADCCP04 Constructional Praxis: Cube
ADAS-COG CONSTRUCTIO
NAL PRAXIS DETAIL
CORRECT CORRECT
75 2324-P0001 75 05E ADCCPS Attempt to Draw ADAS-COG CONSTRUCTIO
NAL PRAXIS DETAIL
76 2324-P0001 76 06 ADCIP Ideational Praxis ADAS-COG IDEATIONAL
PRAXIS SUMMARY
Difficulty to perform 1 task
1 Y
77 2324-P0001 77 06A ADCIP01 Ideational
Praxis: Fold ADAS-COG
IDEATIONAL PRAXIS DETAIL
INCORRECT INCORRECT
78 2324-P0001 78 06B ADCIP02 Ideational
Praxis: Insert ADAS-COG
IDEATIONAL PRAXIS DETAIL
CORRECT CORRECT
79 2324-P0001 79 06C ADCIP03 Ideational
Praxis: Seal ADAS-COG
IDEATIONAL PRAXIS DETAIL
CORRECT CORRECT
80 2324-P0001 80 06D ADCIP04 Ideational
Praxis: Address ADAS-COG
IDEATIONAL PRAXIS DETAIL
CORRECT CORRECT
81 2324-P0001 81 06E ADCIP05 Ideational
Praxis: Stamp ADAS-COG
IDEATIONAL PRAXIS
CORRECT CORRECT
CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )
© 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 9 January 26, 2011
Row USUBJID QSSEQ QSSPID QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSDRVFL QSSTAT QSREASND QSTPT QSTPTNUM DETAIL
82 2324-P0001 82 07 ADCOR Orientation ADAS-COG ORIENTATION
SUMMARY 2 Items
Incorrect 2 Y
83 2324-P0001 83 07A ADCOR01 Orientation: Full
Name ADAS-COG
ORIENTATION DETAIL
INCORRECT INCORRECT
84 2324-P0001 84 07B ADCOR02 Orientation:
Month ADAS-COG
ORIENTATION DETAIL
INCORRECT INCORRECT
85 2324-P0001 85 07C ADCOR03 Orientation:
Date ADAS-COG
ORIENTATION DETAIL
CORRECT CORRECT
86 2324-P0001 86 07D ADCOR04 Orientation:
Year ADAS-COG
ORIENTATION DETAIL
CORRECT CORRECT
87 2324-P0001 87 07E ADCOR05 Orientation: Day
of Week ADAS-COG
ORIENTATION DETAIL
CORRECT CORRECT
88 2324-P0001 88 07F ADCOR06 Orientation:
Season ADAS-COG
ORIENTATION DETAIL
CORRECT CORRECT
89 2324-P0001 89 07G ADCOR07 Orientation:
Place ADAS-COG
ORIENTATION DETAIL
CORRECT CORRECT
90 2324-P0001 90 07H ADCOR08 Orientation:
Time ADAS-COG
ORIENTATION DETAIL
CORRECT CORRECT
91 2324-P0001 91 08 ADCRG Word
Recognition ADAS-COG
WORD RECOGNITION
SUMMARY 2 2 Y
92 2324-P0001 92 08T1 ADCRGT01 Word
Recognition Trial 1
ADAS-COG WORD
RECOGNITION DETAIL
2 Words Incorrect
2
Trial 1 1
93 2324-P0001 93 08T1W01 ADCRGW01 Word
Recognition: Word [1]
ADAS-COG WORD
RECOGNITION DETAIL
INCORRECT INCORRECT
Trial 1 1
… 2324-P0001 … … … … … … … … … …
116 2324-P0001 116 08T1W24 ADCRGW24 Word
Recognition: Word [24]
ADAS-COG WORD
RECOGNITION DETAIL
CORRECT CORRECT
Trial 1 1
117 2324-P0001 117 08T2 ADCRGT02 Word
Recognition Trial 2
ADAS-COG WORD
RECOGNITION DETAIL
2 Words Incorrect
2
Trial 2 2
118 2324-P0001 118 08T2W01 ADCRGW01 Word
Recognition: Word [1]
ADAS-COG WORD
RECOGNITION DETAIL
INCORRECT INCORRECT
Trial 2 2
… 2324-P0001 … … … … … … … … … …
141 2324-P0001 141 08T2W24 ADCRGW24 Word
Recognition: Word [24]
ADAS-COG WORD
RECOGNITION DETAIL
CORRECT CORRECT
Trial 2 2
142 2324-P0001 142 08T3 ADCRGT03 Word
Recognition Trial 3
ADAS-COG WORD
RECOGNITION DETAIL
2 Words Incorrect
2
Trial 3 3
143 2324-P0001 143 08T3W01 ADCRGW01 Word
Recognition: Word [1]
ADAS-COG WORD
RECOGNITION DETAIL
INCORRECT INCORRECT
Trial 3 3
CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )
Page 10 © 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved January 26, 2011
Row USUBJID QSSEQ QSSPID QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSDRVFL QSSTAT QSREASND QSTPT QSTPTNUM … 2324-P0001 … … … … … … … … … …
166 2324-P0001 166 08T3W24 ADCRGW24 Word
Recognition: Word [24]
ADAS-COG WORD
RECOGNITION DETAIL
CORRECT CORRECT
Trial 3 3
167 2324-P0001 167 09 ADCRI Remembering
Test Instructions ADAS-COG
DEGREE OF IMPAIRMENT
No impairment; patient never needs extra reminders of instructions
0
168 2324-P0001 168 10 ADCSL Spoken
Language Ability
ADAS-COG DEGREE OF
IMPAIRMENT
Very mild; one instance
of understandabil
ity
1
169 2324-P0001 169 11 ADCDIF Word Finding Difficulty in Spont Speech
ADAS-COG DEGREE OF
IMPAIRMENT
Mild; noticeable
circumlocution or synonym substitution
2
170 2324-P0001 170 12 ADCCMP Comprehension ADAS-COG DEGREE OF
IMPAIRMENT
No impairment;
patient understands
0
171 2324-P0001 171 13 ADCCON Concentration/D
istractibility ADAS-COG
DEGREE OF IMPAIRMENT
Very mild; one instance
of poor concentration
1
172 2324-P0001 172 14 ADCNC Number
Cancellation ADAS-COG
NUMBER CANCELLATION SUMMARY
18-23 Correct *
2* Y
173 2324-P0001 173 14A ADCNC01 Number
Cancellation: Correct
ADAS-COG NUMBER
CANCELLATION DETAIL
18 18
174 2324-P0001 174 14B ADCNC02 Number
Cancellation: Errors
ADAS-COG NUMBER
CANCELLATION DETAIL
0 0
175 2324-P0001 175 14C ADCNC03 Number
Cancellation: Remind
ADAS-COG NUMBER
CANCELLATION DETAIL
0 0
176 2324-P0001 176 15 ADCMZ Executive
Function maze ADAS-COG
EXECUTIVE FUNCTION
MAZE SUMMARY
* * Y
177 2324-P0001 177 15A ADCMZ01 Executive
Function maze: Errors
ADAS-COG EXECUTIVE FUNCTION
MAZE DETAIL 2 2
178 2324-P0001 178 15B ADCMZ02 Executive
Function maze: ADAS-COG
EXECUTIVE FUNCTION
42 PT42S
CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )
© 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 11 January 26, 2011
Row USUBJID QSSEQ QSSPID QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSDRVFL QSSTAT QSREASND QSTPT QSTPTNUM Time MAZE DETAIL
179 2324-P0002 1 01 ADCRL Word Recall ADAS-COG WORD
RECALL SUMMARY
5 Y
180 2324-P0002 2 01T1 ADCRLT01 Word Recall
Trial 1 ADAS-COG
WORD RECALL DETAIL
5 Y Trial 1 1
181 2324-P0002 3 01T1W01 ADCRLW01 Word Recall:
Word [1] ADAS-COG
WORD RECALL DETAIL
NOT
DONE Cognitive Reasons
Trial 1 1
182 2324-P0002 4 … … … ADAS-COG WORD
RECALL DETAIL
… … … … … Trial 1 1
183 2324-P0002 5 01T1W10 ADCRLW10 Word Recall:
Word [10] ADAS-COG
WORD RECALL DETAIL
NOT
DONE Cognitive Reasons
Trial 1 1
184 2324-P0002 6 01T2 ADCRLT02 Word Recall
Trial 2 ADAS-COG
WORD RECALL DETAIL
5 Y Trial 2 2
185 2324-P0002 7 01T2W01 ADCRLW01 Word Recall:
Word [1] ADAS-COG
WORD RECALL DETAIL
NOT
DONE Cognitive Reasons
Trial 2 2
186 2324-P0002 8 … … … ADAS-COG WORD
RECALL DETAIL
… … … … … Trial 2 2
187 2324-P0002 9 01T2W10 ADCRLW10 Word Recall:
Word [10] ADAS-COG
WORD RECALL DETAIL
NOT
DONE Cognitive Reasons
Trial 2 2
188 2324-P0002 10 01T3 ADCRLT03 Word Recall
Trial 3 ADAS-COG
WORD RECALL DETAIL
5 Y Trial 3 3
189 2324-P0002 11 01T3W01 ADCRLW01 Word Recall:
Word [1] ADAS-COG
WORD RECALL DETAIL
NOT
DONE Cognitive Reasons
Trial 3 3
190 2324-P0002 12 … … … ADAS-COG WORD
RECALL DETAIL
… … … … … Trial 3 3
191 2324-P0002 13 01T3W10 ADCRLW10 Word Recall:
Word [10] ADAS-COG
WORD RECALL DETAIL
NOT
DONE Cognitive Reasons
Trial 3 3
192 2324-P0002 14 02 ADCOF Naming Objects
and Fingers ADAS-COG
NAMING OBJECTS AND
FINGERS SUMMARY
Y
193 2324-P0002 15 02A ADCOFO01 Naming Objects and Fingers: 1
ADAS-COG
NAMING OBJECTS AND
FINGERS DETAIL
NOT
DONE
Non-Cognitive Reasons
CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )
Page 12 © 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved January 26, 2011
Row USUBJID QSSEQ QSSPID QSTESTCD QSTEST QSCAT QSSCAT QSORRES QSSTRESC QSDRVFL QSSTAT QSREASND QSTPT QSTPTNUM
194 2324-P0002 16 … … … ADAS-COG
NAMING OBJECTS AND
FINGERS DETAIL
… … … … …
195 2324-P0002 17 02L ADCOFO12 Naming Objects and Fingers: 12
ADAS-COG
NAMING OBJECTS AND
FINGERS DETAIL
NOT
DONE
Non-Cognitive Reasons
196 2324-P0002 18 02M ADCOFF01 Naming Objects
and Fingers: Thumb
ADAS-COG
NAMING OBJECTS AND
FINGERS DETAIL
NOT
DONE
Non-Cognitive Reasons
197 2324-P0002 19 02N ADCOFF02 Naming Objects
and Fingers: Pointer
ADAS-COG
NAMING OBJECTS AND
FINGERS DETAIL
NOT
DONE
Non-Cognitive Reasons
198 2324-P0002 20 02O ADCOFF03 Naming Objects
and Fingers: Middle
ADAS-COG
NAMING OBJECTS AND
FINGERS DETAIL
NOT
DONE
Non-Cognitive Reasons
199 2324-P0002 21 02P ADCOFF04 Naming Objects
and Fingers: Ring
ADAS-COG
NAMING OBJECTS AND
FINGERS DETAIL
NOT
DONE
Non-Cognitive Reasons
200 2324-P0002 22 02Q ADCOFF05 Naming Objects
and Fingers: Pinky
ADAS-COG
NAMING OBJECTS AND
FINGERS DETAIL
NOT
DONE
Non-Cognitive Reasons
*Values for QSORRES and QSTRESC for Number Cancellation Summary and Executive Function Maze Summary results will be populated pending publication of an accepted algorithm by the Alzheimer’s Disease Cooperative Study (ADCS).
CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )
© 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 13 January 26, 2011
Appendices
APPENDIX 1: QUESTIONNAIRE COPYRIGHT STATUS
CDISC has obtained permission to include the ADAS-Cog questionnaire as part of CDISC Data Standards. This means that CDISC developed QSTESTCD and QSTEST for each question based on the actual question text on the questionnaire. The instrument itself was not changed. The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples and (3) case report forms annotated with the CDISC SDTMIG submission values. CDISC has developed this documentation at no cost to copyright holder or any additional cost to users of the instrument beyond the normal licenses fees charged by the copyright holder. CDISC acknowledges Dr. Richard Mohs for his agreement to include the ADAS-Cog scale in the CDISC data standards. Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. The author’s consent ensures that the data captured using this instrument will be done so in a standardized manner thereby facilitating collection, database storage, reporting and regulatory review of that data. CDISC wants to emphasize that the existing copyright status as well as the existing procedures for licensing fees and using the instrument will remain exactly as they have been. Please follow the instrument owners own mechanisms for permissions and licenses if you have a need to use this questionnaire.
CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )
Page 14 © 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved January 26, 2011
APPENDIX 2: MAPPING STRATEGY FOR SDTM VARIABLES
QS ADAS-Cog specific mapping strategy : QSTPTNUM and QSTPT QSTPTNUM QSTPT 1 Trial 1 2 Trial 2 3 Trial 3
QSTEST= Word Recall Trial 1, Word Recall Trial 2, Word Recall Trial 3 QSORRES QSSTRESC QSSTRESN
0 Words Not Recalled 0 0
1 Words Not Recalled 1 1
2 Words Not Recalled 2 2
3 Words Not Recalled 3 3
4 Words Not Recalled 4 4
5 Words Not Recalled 5 5
6 Words Not Recalled 6 6
7 Words Not Recalled 7 7
8 Words Not Recalled 8 8
9 Words Not Recalled 9 9
10 Words Not Recalled 10 10 QSSCAT=WORD RECALL DETAIL QSTEST=Word Recall: Word 1 to Word Recall: Word 10
QSTEST QSSCAT QSORRES QSSTRESC Word Recall: Word [1] WORD RECALL DETAIL RECALLED RECALLED Word Recall: Word [1] WORD RECALL DETAIL NOT RECALLED NOT RECALLED
… WORD RECALL DETAIL … … Word Recall: Word [10] WORD RECALL DETAIL RECALLED RECALLED Word Recall: Word [10] WORD RECALL DETAIL NOT RECALLED NOT RECALLED QSTEST= Naming Objects and Fingers QSORRES QSSTRESC QSSTRESN
0-2 items incorrect 0 0
3-5 items incorrect 1 1
6-8 items incorrect 2 2
9-11 items incorrect 3 3
12-14 items incorrect 4 4
15-17 items incorrect 5 5
QSSCAT= NAMING OBJECTS AND FINGERS DETAIL
CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )
© 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 15 January 26, 2011
QSTEST=Word Recall: Word 1 to Word Recall: Word 10 QSTEST QSSCAT QSORRES QSSTRESC
Naming Objects and Fingers: 1 NAMING OBJECTS AND FINGERS
DETAIL CORRECT CORRECT
Naming Objects and Fingers: 1 NAMING OBJECTS AND FINGERS
DETAIL INCORRECT INCORRECT
… NAMING OBJECTS AND FINGERS
DETAIL … …
Naming Objects and Fingers: 12 NAMING OBJECTS AND FINGERS
DETAIL CORRECT CORRECT
Naming Objects and Fingers: 12 NAMING OBJECTS AND FINGERS
DETAIL INCORRECT INCORRECT
Naming Objects and Fingers: Thumb
NAMING OBJECTS AND FINGERS DETAIL
CORRECT CORRECT
Naming Objects and Fingers: Thumb
NAMING OBJECTS AND FINGERS DETAIL
INCORRECT INCORRECT
Naming Objects and Fingers: Pointer
NAMING OBJECTS AND FINGERS DETAIL
CORRECT CORRECT
Naming Objects and Fingers: Pointer
NAMING OBJECTS AND FINGERS DETAIL
INCORRECT INCORRECT
Naming Objects and Fingers: Middle
NAMING OBJECTS AND FINGERS DETAIL
CORRECT CORRECT
Naming Objects and Fingers: Middle
NAMING OBJECTS AND FINGERS DETAIL
INCORRECT INCORRECT
Naming Objects and Fingers: Ring NAMING OBJECTS AND FINGERS
DETAIL CORRECT CORRECT
Naming Objects and Fingers: Ring NAMING OBJECTS AND FINGERS
DETAIL INCORRECT INCORRECT
Naming Objects and Fingers: Pinky
NAMING OBJECTS AND FINGERS DETAIL
CORRECT CORRECT
Naming Objects and Fingers: Pinky
NAMING OBJECTS AND FINGERS DETAIL
INCORRECT INCORRECT
QSTEST= Commands QSORRES QSSTRESC QSSTRESN
5 Commands Correct 0 0
4 Commands Correct 1 1
3 Commands Correct 2 2
2 Commands Correct 3 3
1 Commands Correct 4 4
All Commands Incorrect 5 5
QSSCAT= COMMANDS DETAIL QSTEST= Commands: Fist to Commands: Shoulder Word 10
QSTEST QSSCAT QSORRES QSSTRESC Commands: Fist COMMANDS DETAIL CORRECT CORRECT
CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )
Page 16 © 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved January 26, 2011
QSTEST QSSCAT QSORRES QSSTRESC Commands: Fist COMMANDS DETAIL INCORRECT INCORRECT
… COMMANDS DETAIL … … Commands: Shoulder COMMANDS DETAIL CORRECT CORRECT Commands: Shoulder COMMANDS DETAIL INCORRECT INCORRECT QSTEST= Delayed Word Recall QSORRES QSSTRESC QSSTRESN
0 Words Not Recalled 0 0
1 Words Not Recalled 1 1
2 Words Not Recalled 2 2
3 Words Not Recalled 3 3
4 Words Not Recalled 4 4
5 Words Not Recalled 5 5
6 Words Not Recalled 6 6
7 Words Not Recalled 7 7
8 Words Not Recalled 8 8
9 Words Not Recalled 9 9
10 Words Not Recalled 10 10
QSSCAT= DELAYED WORD RECALL DETAIL QSTEST= Delayed Word Recall: Word [1] to Delayed Word Recall: Word [10]
QSTEST QSSCAT QSORRES QSSTRESC Delayed Word Recall: Word [1] DELAYED WORD RECALL DETAIL CORRECT CORRECT Delayed Word Recall: Word [1] DELAYED WORD RECALL DETAIL INCORRECT INCORRECT
… DELAYED WORD RECALL DETAIL … … Delayed Word Recall: Word [10] DELAYED WORD RECALL DETAIL CORRECT CORRECT Delayed Word Recall: Word [10] DELAYED WORD RECALL DETAIL INCORRECT INCORRECT
QSTEST= Constructional Praxis QSORRES QSSTRESC QSSTRESN
All four drawings correct 0 0
1 form drawn incorrectly 1 1
2 forms drawn incorrectly 2 2
3 forms drawn incorrectly 3 3
4 forms drawn incorrectly 4 4
No figures drawn;scribbles;parts of forms;words instead of forms 5 5 QSSCAT= CONSTRUCTIONAL PRAXIS DETAIL QSTEST= Constructional Praxis: Circle to Attempt Draw
QSTEST QSSCAT QSORRES QSSTRESC
CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )
© 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 17 January 26, 2011
QSTEST QSSCAT QSORRES QSSTRESC Constructional Praxis: Circle
CONSTRUCTIONAL PRAXIS DETAIL
CORRECT CORRECT
Constructional Praxis: Circle
CONSTRUCTIONAL PRAXIS DETAIL
INCORRECT INCORRECT
… CONSTRUCTIONAL
PRAXIS DETAIL … …
Constructional Praxis: Cube
CONSTRUCTIONAL PRAXIS DETAIL
CORRECT CORRECT
Constructional Praxis: Cube
CONSTRUCTIONAL PRAXIS DETAIL
INCORRECT INCORRECT
Attempt to Draw CONSTRUCTIONAL PRAXIS DETAIL
Attempt to Draw CONSTRUCTIONAL
PRAXIS DETAIL NONE: Attempted but drew
no forms correctly NONE: Attempted but drew
no forms correctly
QSTEST= Ideational Praxis QSORRES QSSTRESC QSSTRESN
All tasks completed successfully 0 0
Difficulty to perform 1 task 1 1
Difficulty to perform 2 tasks 2 2
Difficulty to perform 3 tasks 3 3
Difficulty to perform 4 tasks 4 4
Difficulty to perform 5 tasks 5 5 QSSCAT= IDEATIONAL PRAXIS DETAIL QSTEST= Ideational Praxis: Fold to Ideational Praxis: Stamp
QSTEST QSSCAT QSORRES QSSTRESC Ideational Praxis: Fold IDEATIONAL PRAXIS DETAIL CORRECT CORRECT Ideational Praxis: Fold IDEATIONAL PRAXIS DETAIL INCORRECT INCORRECT
… IDEATIONAL PRAXIS DETAIL … … Ideational Praxis: Stamp IDEATIONAL PRAXIS DETAIL CORRECT CORRECT Ideational Praxis: Stamp IDEATIONAL PRAXIS DETAIL INCORRECT INCORRECT
QSTEST= Orientation QSORRES QSSTRESC QSSTRESN
0 Items Incorrect 0 0
1 Items Incorrect 1 1
2 Items Incorrect 2 2
3 Items Incorrect 3 3
4 Items Incorrect 4 4
5 Items Incorrect 5 5
6 Items Incorrect 6 6
7 Items Incorrect 7 7
8 Items Incorrect 8 8
CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )
Page 18 © 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved January 26, 2011
QSSCAT= ORIENTATION DETAIL QSTEST= Orientation: Full Name to Orientation: Time
QSTEST QSSCAT QSORRES QSSTRESC Orientation: Full Name ORIENTATION DETAIL CORRECT CORRECT Orientation: Full Name ORIENTATION DETAIL INCORRECT INCORRECT
… ORIENTATION DETAIL … … Orientation: Time ORIENTATION DETAIL CORRECT CORRECT Orientation: Time ORIENTATION DETAIL INCORRECT INCORRECT
QSTEST= Word Recognition Trial 1, Word Recognition Trial 2, Word Recognition Trial 3 QSORRES QSSTRESC QSSTRESN
0 Words Incorrect 0 0
1 Words Incorrect 1 1
2 Words Incorrect 2 2
3 Words Incorrect 3 3
4 Words Incorrect 4 4
5 Words Incorrect 5 5
6 Words Incorrect 6 6
7 Words Incorrect 7 7
8 Words Incorrect 8 8
9 Words Incorrect 9 9
10 Words Incorrect 10 10
11 Words Incorrect 11 11
12-24 Words Incorrect 12 12 QSSCAT= WORD RECOGNITION DETAIL QSTEST= Word Recognition: Word [1] to Word Recognition: Word [24]
QSTEST QSSCAT QSORRES QSSTRESC Word Recognition: Word [1] WORD RECOGNITION DETAIL CORRECT CORRECT Word Recognition: Word [1] WORD RECOGNITION DETAIL INCORRECT INCORRECT
… WORD RECOGNITION DETAIL … … Word Recognition: Word [24] WORD RECOGNITION DETAIL CORRECT CORRECT Word Recognition: Word [24] WORD RECOGNITION DETAIL INCORRECT INCORRECT QSTEST= Remembering Test Instructions QSORRES QSSTRESC QSSTRESN
No impairment; patient never needs extra reminders of instructions 0 0
Very mild; forgets once 1 1
Mild; must be reminded 2 times 2 2
Moderate; must be reminded 3 or 4 times 3 3
Moderately severe; must be reminded 5 or 6 times 4 4
Severe; must be reminded 7 or more times 5 5
CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )
© 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 19 January 26, 2011
QSTEST= Spoken Language Ability QSORRES QSSTRESC QSSTRESN
No impairment; patient speaks clearly and/or is understandable 0 0
Very mild; one instance of lack of understandability 1 1
Mild; patient has difficulty < 25% of time 2 2
Moderate; patient has difficulty 25-50% of time 3 3
Moderately severe; patient has difficulty >50% of time 4 4
Severe; one or two word utterances; fluent, but empty speech; mute 5 5
QSTEST= Word Finding Difficulty in Spont Speech QSORRES QSSTRESC QSSTRESN
No evidence of word-finding difficulty in spontaneous speech 0 0
Very mild; one or two instances, not clinically significant 1 1
Mild; noticeable circumlocution or synonym substitution 2 2
Moderate; loss of words with compensation on occasion 3 3
Moderately severe; frequent loss of words without compensation 4 4 Severe; near total loss of content words; speech sounds empty, one or two word utterances 5 5
QSTEST= Comprehension QSORRES QSSTRESC QSSTRESN
No impairment; patient understands 0 0
Very mild; one or two instances of misunderstanding 1 1
Mild; 3-5 instances of misunderstanding 2 2
Moderate; requires several repetitions and rephrasings 3 3 Moderately severe; patient only occasionally responds correctly, i.e., yes/no questions 4 4 Severe; patient rarely responds to questions appropriately, not to property of speech 5 5
QSTEST= Concentration/Distractibility QSORRES QSSTRESC QSSTRESN
None; no evidence of concentration or distractibility 0 0
Very mild; one instance of poor concentration 1 1 Mild; 2-3 instances of poor concentration or distractibility; signs of restlessness and inattentiveness 2 2
Moderate; 4-5 instances during interview 3 3 Moderately severe; poor concentration/distractibility throughout much of the interview 4 4 Severe; extreme difficulty in concentration and extremely distractible, unable to complete tasks 5 5
CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )
Page 20 © 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved January 26, 2011
QSTEST= Number Cancellation QSORRES QSSTRESC QSSTRESN
>=31 Correct 0 0
24-30 Correct 1 1
18-23 Correct 2 2
12-17 Correct 3 3
6-11 Correct 4 4
0-5 Correct 5 5
QSTEST= Executive Function maze QSORRES QSSTRESC QSSTRESN
0-30 sec and 0-1 Errors 0 0
31-60 sec and 0-1 Errors 1 1
61-90 sec and 0-1 Errors 2 2
91-120 sec and 0-1 Errors 3 3
121-239 sec and 0-1 Errors 4 4
>= 240 sec or >=2 Errors 5 5
APPENDIX 3: SUPPLEMENTAL QUALIFIERS NAME CODES
The following table contains an additional standard name code for use in the Supplemental Qualifiers (SUPP--) special-purpose datasets. There are no SUPPQUAL fields related to the ADAS-Cog questionnaire. See SDTMIG Appendix C5 for other supplemental qualifier name codes. QNAM QLABEL Applicable Domains
CDISC SDTM ADAS-Cog Questionnaire Supplement (Versi on 1.0 )
© 2011 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 21 January 26, 2011
APPENDIX F: REPRESENTATIONS AND WARRANTIES, LIMITA TIONS OF LIABILITY, AND DISCLAIMERS
CDISC Patent Disclaimers It is possible that implementation of and compliance with this standard may require use of subject matter covered by patent rights. By publication of this standard, no position is taken with respect to the existence or validity of any claim or of any patent rights in connection therewith. CDISC, including the CDISC Board of Directors, shall not be responsible for identifying patent claims for which a license may be required in order to implement this standard or for conducting inquiries into the legal validity or scope of those patents or patent claims that are brought to its attention. Representations and Warranties Each Participant in the development of this standard shall be deemed to represent, warrant, and covenant, at the time of a Contribution by such Participant (or by its Representative), that to the best of its knowledge and ability: (a) it holds or has the right to grant all relevant licenses to any of its Contributions in all jurisdictions or territories in which it holds relevant intellectual property rights; (b) there are no limits to the Participant’s ability to make the grants, acknowledgments, and agreements herein; and (c) the Contribution does not subject any Contribution, Draft Standard, Final Standard, or implementations thereof, in whole or in part, to licensing obligations with additional restrictions or requirements inconsistent with those set forth in this Policy, or that would require any such Contribution, Final Standard, or implementation, in whole or in part, to be either: (i) disclosed or distributed in source code form; (ii) licensed for the purpose of making derivative works (other than as set forth in Section 4.2 of the CDISC Intellectual Property Policy (“the Policy”)); or (iii) distributed at no charge, except as set forth in Sections 3, 5.1, and 4.2 of the Policy. If a Participant has knowledge that a Contribution made by any Participant or any other party may subject any Contribution, Draft Standard, Final Standard, or implementation, in whole or in part, to one or more of the licensing obligations listed in Section 9.3, such Participant shall give prompt notice of the same to the CDISC President who shall promptly notify all Participants. No Other Warranties/Disclaimers. ALL PARTICIPANTS ACKNOWLEDGE THAT, EXCEPT AS PROVIDED UNDER SECTION 9.3 OF THE CDISC INTELLECTUAL PROPERTY POLICY, ALL DRAFT STANDARDS AND FINAL STANDARDS, AND ALL CONTRIBUTIONS TO FINAL STANDARDS AND DRAFT STANDARDS, ARE PROVIDED “AS IS” WITH NO WARRANTIES WHATSOEVER, WHETHER EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, AND THE PARTICIPANTS, REPRESENTATIVES, THE CDISC PRESIDENT, THE CDISC BOARD OF DIRECTORS, AND CDISC EXPRESSLY DISCLAIM ANY WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT, FITNESS FOR ANY PARTICULAR OR INTENDED PURPOSE, OR ANY OTHER WARRANTY OTHERWISE ARISING OUT OF ANY PROPOSAL, FINAL STANDARDS OR DRAFT STANDARDS, OR CONTRIBUTION. Limitation of Liability IN NO EVENT WILL CDISC OR ANY OF ITS CONSTITUENT PARTS (INCLUDING, BUT NOT LIMITED TO, THE CDISC BOARD OF DIRECTORS, THE CDISC PRESIDENT, CDISC STAFF, AND CDISC MEMBERS) BE LIABLE TO ANY OTHER PERSON OR ENTITY FOR ANY LOSS OF PROFITS, LOSS OF USE, DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR SPECIAL DAMAGES, WHETHER UNDER CONTRACT, TORT, WARRANTY, OR OTHERWISE, ARISING IN ANY WAY OUT OF THIS POLICY OR ANY RELATED AGREEMENT, WHETHER OR NOT SUCH PARTY HAD ADVANCE NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. Note: The CDISC Intellectual Property Policy can be found at http://www.cdisc.org/about/bylaws_pdfs/CDISCIPPolicy-FINAL.pdf.