Animation in DTC Promotion

Data to Support Drug Product Communications as Used by the FDA

FDA Animation_Cog Int_Attachment A_Screener

Animation in DTC Promotion

OMB: 0910-0695

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Attachment A:
Animation in DTC Advertising
Cognitive Interview Screener
Introduction
Hello, my name is _______________ and I’m from [name of company]. I’m calling on behalf of
RTI International, a non-profit research organization, about a research study. I’m not selling or
promoting any product. (Ask to speak to someone 18 years or older.)
The purpose of this study is to learn more about how people watch TV. To see if you are
eligible, I’d like to ask you some questions. If you are eligible and choose to participate, all of
your comments will be kept private and we will reimburse you $100 at the end of the interview.
May I continue?
Yes  CONTINUE
No  [Thank respondent and end call.]
[SCREENER]
1. Have you participated in any market research interviews such as a focus group or one-on-one
interview in the past three months?
Yes  [Thank respondent and end call.]
No  CONTINUE
[ILLNESS DIAGNOSIS]
2. Have you ever been diagnosed with any of the following health conditions by a doctor or other
qualified health care provider? (Select all that apply) (Read all conditions.)
Angina  TERMINATE
Chronic Dry Eye  CONTINUE
Chronic Pain  TERMINATE
Diabetes  TERMINATE
Hypertension  TERMINATE
Psoriasis  CONTINUE
None of the above  TERMINATE
Don’t know/Don’t remember  TERMINATE
[If participant selects Chronic Dry Eye AND/OR Psoriasis  CONTINUE]
3. Do any of the following statements apply to you? (Read all applicable statements.)
[For people diagnosed with psoriasis only OR people with psoriasis and chronic dry eye]
I am currently taking medication for my psoriasis.  CONTINUE

I currently have psoriasis but I am not taking any medication
for this condition.  CONTINUE
[For people diagnosed with chronic dry eye only OR people with psoriasis and
chronic dry eye]
I am currently taking medication for my chronic dry eye.  CONTINUE
I currently have chronic dry eye but I am not taking any medication
for this condition.  CONTINUE
[If participant does not select any of the statements  TERMINATE]
[OCCUPATION]
4. What is your current occupation?
Healthcare provider (e.g., physician, nurse, counselor)  TERMINATE
Pharmaceutical employee (e.g., Pharma Rep)  TERMINATE
Department of Health and Human Services employee  TERMINATE
Market research employee or advertising employee  TERMINATE
Refused to answer  TERMINATE
None of the above  CONTINUE
[EDUCATION]
[QUOTA REQUIREMENT: Highest education level for 20% of sample must be high school
graduate or less]
5. What is the highest level of education you have completed?
Less than high school
High school graduate (high school diploma or GED)
Some college, but no degree
Associate’s degree (2-year)
Bachelor’s degree (4-year) (example: BA, BS)
Advanced or postgraduate degree (example: MA, MD, DDS, JD, PhD, EdD)
[AGE]
[Screen for a mix]
6. What year were you born? __________ [1998 or later  TERMINATE]
[SEX]
[Screen for a mix]
7. What is your sex?
Male
Female

[RACE/ETHNICITY]
[Screen for a mix]
8. Are you Hispanic or Latino?
Yes
No
9. What is your race?
White
Black / African American
American Indian or Alaskan Native
Asian
Native Hawaiian or Pacific Islander
Other
[Closing for INELIGIBLE participants]
We’re sorry, but you are not eligible for this study. There are many possible reasons why people
are not eligible for this study. These reasons were decided earlier by the researchers. However,
thank you for your interest in this study and for taking the time to answer our questions today.
[Closing for ELIGIBLE participants]
Thank you for answering these questions. Based on your responses, you appear to be eligible to
participate in our study.
This study involves an advertisement for a new product. You will watch the ad and then you’ll
be asked some questions about it. The study will take about 60 minutes to complete and you will
receive $100 at the end. No one will try to sell you anything, and no one will call you later
because you participated.
May I schedule your participation?
Yes  CONTINUE
No  [Thank respondent and end call.]
The interviews will take place on [DATES AND TIMES TBD]. Which date and time would
work best for you?
Your participation in this study is very important. If for some reason you will not be able to
attend, please let us know right away. You can call us anytime at [INSERT PHONE NUMBER],
and if we are not here, please leave a message.

Participant Information
NAME:
________________________________________________________
ADDRESS: ________________________________________________________
CITY:
________________________________________________________
ZIP CODE: ________________________________________________________
EMAIL:
________________________________________________________
What is the best time to reach you? What is the best telephone number to reach you at that time?
BEST TIME TO BE REACHED:

________________________________________

BEST PHONE NUMBER:

________________________________________

Is there another time and number we can try if we miss you?
ALTERNATE PHONE NUMBER: ________________________________________

Recruiter: ____________________


File Typeapplication/pdf
File TitleMicrosoft Word - FDA Animation _Cognitive Interview OMB Memo_Appendix A.doc
Authorrpaquin
File Modified2016-02-29
File Created2016-02-29

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