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Document Name: CREST-E BLINDEDNESS QUESTIONNAIRE
Document Accession: phd007415.1

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CREST-E BLINDEDNESS QUESTIONNAIRE

(9/14/10) 9/21/10

116 | 40

BLINDI

SUBJECT ID VISIT NO
INITIALS SITE NO VISIT DATE MM DD YYYY
1. Questionnaire completed by:
1 = Investigator
Link to associated variable2. Which treatment do you believe the subject (or you, if you are the subject) was assigned to during this study?
1 = Placebo2 = Active Drug
Link to associated variable3. How sure are you of this answer?
1 = very sure2 = somewhat sure3 = not sure at all
Associated links4. Provide the primary and secondary reasons for your treatment guess:
4.1. primary
1 = improvement in symptoms of disease under study
2 = lack of improvement in symptoms of disease under study
3 = adverse effects of study medication (specify below)
4 = lack of adverse effects of study medication
5 = appearance, taste or odor or other physical characteristics of the study medication (specify below)
6 = other reasons (specify below)
4.2. secondary
1 = improvement in symptoms of disease under study
2 = lack of improvement in symptoms of disease under study
3 = adverse effects of study medication (specify below)
4 = lack of adverse effects of study medication
5 = appearance, taste or odor or other physical characteristics of the study medication (specify below)
6 = other reasons (specify below)
7 = no secondary reason provided (do not use for primary reason)
5. If response to question 4 is 3, 5 or 6, please specify.

BLINDS

SUBJECT ID VISIT NO
INITIALS SITE NO VISIT DATE MM DD YYYY
1. Questionnaire completed by:
3 = Subject
2. Which treatment do you believe the subject (or you, if you are the subject) was assigned to during this study?
1 = Placebo2 = Active Drug
3. How sure are you of this answer?
1 = very sure2 = somewhat sure3 = not sure at all
4. Provide the primary and secondary reasons for your treatment guess:
4.1. primary
1 = improvement in symptoms of disease under study
2 = lack of improvement in symptoms of disease under study
3 = adverse effects of study medication (specify below)
4 = lack of adverse effects of study medication
5 = appearance, taste or odor or other physical characteristics of the study medication (specify below)
6 = other reasons (specify below)
4.2. secondary
1 = improvement in symptoms of disease under study
2 = lack of improvement in symptoms of disease under study
3 = adverse effects of study medication (specify below)
4 = lack of adverse effects of study medication
5 = appearance, taste or odor or other physical characteristics of the study medication (specify below)
6 = other reasons (specify below)
7 = no secondary reason provided (do not use for primary reason)
5. If response to question 4 is 3, 5 or 6, please specify.