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

Dear [PARTICIPANT FIRST NAME]:

Thank you for agreeing to join our interview about health-related materials. The video interview is scheduled for [DAY, DATE] at [START TIME – END TIME] Eastern Time. It will take place online and will last about 90 minutes. This message contains important information you will need to prepare for the interview and to join it.

STEP 1: COMPLETE CONSENT FORM (2 DAYS BEFORE INTERVIEW)

First, please read the study’s consent form, which you can access via the link below. It explains the purpose of our conversation and outlines your rights and responsibilities as a participant. If you agree to participate, you must complete the form at least 48 hours (2 days) before the interview. After you complete the form, L&E Research will e-mail you a downloadable copy for your records.

Study Consent Form

[LINK HERE]

For study purposes, the interview will be audio and video recorded.

STEP 2: CONDUCT VIDEO TEST (2 DAYS BEFORE INTERVIEW)

We will use a video platform called Zoom for our conversation. You will need a desktop computer, laptop computer, or tablet (not just a smartphone) and a web camera (attached or built into the device) to participate in the online interview.

To make sure that you can join the interview, please test your computer and web camera at least 48 hours (2 days) before the interview. You can test your equipment by clicking on the test link below.

Zoom Test Link

https://zoom.us/test

This test is important to make sure the website works for you. If you have trouble accessing the website, we can try to fix the problem before the interview. You will not be allowed to participate in the interview if the website does not work on your computer.

STEP 3: LOGIN TO INTERVIEW (10 MINUTES BEFORE INTERVIEW)

Log in at least 10 minutes before the interview is scheduled to start. This allows you to test your login information and become familiar with the online format.

Please choose a quiet room where you can participate in private and without any distractions or noise. Alert others in advance that you are giving your full attention to the interview. Turn off your cell phone, television, and anything else that might distract you.

Follow these steps to login:

1. Open Zoom by clicking the following link: ________________

2. If asked, enter the password _______________

3. A pop-up box will appear on your screen requesting to download and run Zoom.

1. If you would like to install Zoom (recommended), click on the file and install the launcher.

2. If you do not want to install Zoom, click the “join from your browser” link.

4. When you join the Zoom meeting, you will be asked to sign in or enter your name. Enter your first name only. Please do not enter your last name, as we want to protect your privacy.

5. Once Zoom opens, choose an audio option—computer (recommended) or phone. If you choose phone audio, please select the option that allows the system to call you. This will suppress your phone number and protect your privacy.

6. Activate your video by clicking the “Start Video” button in the lower left corner of the Zoom window.

You’re all set! You’re now ready to participate in the interview.

PERSONS TO CONTACT

RTI International, a non-profit research organization based in North Carolina, is conducting this study on behalf of the U.S. Food and Drug Administration (FDA). L&E Research is helping to identify study participants and coordinate their participation.

If you experience technical problems when logging into the interview, please email [email protected] for help.

If you have any other questions about this study, you can contact the L&E Research project manager, David Floyd, at (919) 457-1281 or [email protected].

Thank you again for your interest. We look forward to seeing you online soon!