Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Patient and Caregiver Interviews (CDER)

Data to Support Drug Product Communications

Confirmation Script

Studies to Enhance FDA Communications Addressing Biosimilar Drug Products: Patient and Caregiver Interviews (CDER)

OMB: 0910-0695

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Biosimilars Patient Study

Phase 2 Eligibility and Scheduling Confirmation Script


Note: This script will be used only for individuals who complete the web screener.


Hello, this is ____ calling from L&E Research. I’m calling regarding the online interview study about health-related materials you recently expressed interest in.


I’m calling to confirm a few pieces of information you shared with us to ensure you are eligible. If you are, I would like to schedule you to participate in an online interview. As a reminder, this study will involve a 90-minute one-on-one interview, and you will be emailed about your $75 honorarium within one business day after the interview concludes. You will have the option to choose between a physical or electronic gift card.


Can I ask you a few questions now to confirm your eligibility and schedule your participation?

  • Yes CONTINUE

  • No Would another time be better? [Schedule a time to call back]


Medication Use – Illness Conditions

  1. Is it correct that you are currently taking or have previously taken [medication] for [condition]?

  • Yes CONTINUE

  • No UPDATE RESPONSE AND CONFIRM STILL ELIGIBLE


[Repeat Q1 for each medication selected on screener]


  1. Is it correct that you have taken [medication] in the past 6 months or are still taking it?

  • Yes CONTINUE

  • No UPDATE RESPONSE AND CONFIRM STILL ELIGIBLE


Audience Segmentation – Adults with Diabetes

[Ask of all participants assigned to adults with diabetes segment]


  1. Is it correct that you have been using insulin to treat your diabetes for at least one month?

  • Yes CONTINUE

  • No TERMINATE


  1. Is it correct that you take insulin once or more per day?

  • Yes CONTINUE

  • No TERMINATE



Audience Segmentation – Children with Diabetes

[Ask of all participants assigned to parents/caregivers of children with diabetes segment]


  1. Is it correct that your child has been using insulin to treat his or her diabetes for at least one month?

  • Yes CONTINUE

  • No TERMINATE


  1. Is it correct that your child takes insulin once or more per day?

  • Yes CONTINUE

  • No TERMINATE

Computer and Internet Access

  1. Is it correct that you have high-speed Internet at home? That is, are you able to stream video without any difficulty?

  • Yes CONTINUE

  • No TERMINATE


  1. We want to show you health-related materials during the interview that will be too small if viewed on a smartphone. Is it correct that you have a desktop computer, a laptop computer, or a tablet with a webcam that you can use during the interview?

  • Yes CONTINUE

  • No TERMINATE


Closing Scripts

Ineligible - Closing Script

I’m sorry, but you are not eligible for this study. There are many possible reasons why people are not eligible. 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.


Eligible – Scheduling Script

Thank you for confirming that information. You qualify for our study. Next, I’d like to schedule you for an online interview. The interview will last about 90 minutes You will be emailed about your $75 honorarium within one business day after the interview concludes and have the option to choose between a physical or electronic gift card.


Scheduling of Interview Participation

Are you available at [TIME] on [DATE]? [READ NEXT AVAILABLE INTERVIEW TIME]

  • Yes CONTINUE and schedule participant

  • No What time of day would make it easier for you to participate in the interview? RECORD RESPONSE, RETAIN PARTICIPANT AS AN ALTERNATE, AND END CALL

The e-mail address I have on file for you is [E-MAIL ADDRESS] and phone number is [PHONE NUMBER]. Are those still correct? [UPDATE IF NEEDED]

We will reach out with a confirmation email and phone call with instructions to join the interview on [DATE/TIME]. We will also use this information to send you a reminder email and to call and remind you of the interview one day before the interview.

Thank you. We appreciate your participation in this study.


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File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File TitleFDA Online Study
AuthorJackie Amoozegar
File Modified0000-00-00
File Created2022-07-01

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