Collection of Data to Support Training Decay Selection for Medical Product Usability Validation Testing (CDER)

F DA Training Decay Usability Study – Initial Training Script (Insulin Pump)

UserWiseFDA02, Rev 01

OMB Control No.: 0910-0847

Expiration Date: 12/31/2022

Training Decay Usability Study – Initial Training Script (Insulin Pump)

Note: This script is intended to be used at the beginning of the participant’s training session, before the training has started.

1. Key Reminders:

• Make sure the section regarding potential risks has been read out loud to the participant.

• Make sure that the participant has signed the ICF.

2. Introduction and Participant Data

• Hello, my name is ______________. I am the moderator, and I’ll be walking you through this session, and _______________ may observe at times.

• First off, we want to thank you for your time and participation in this usability study.

• Before we get started, do you have any questions about the informed consent form?

• The purpose of this session is to evaluate an insulin pump to identify whether it can be used safely in a simulated use environment.

• The combined results of all the participants in this study will be published, but your identity will always remain anonymous.

• If you feel unwell or wish to end the session at any point for any reason, please let me know.

• For purpose of this evaluation, we request that you turn off your phone. We appreciate your not using your phone throughout the session.

• For purpose of the session today, I want you to imagine that you are a caregiver. Later on, you are going to treat a simulated patient, named Sam. Sam represents a family member or friend whom you are caring for. Please care for him/her as you would care for someone in real life.

• Before you treat Sam, you’ll attend a training that includes 20 minutes of walking through the instructions and approximately 10 minutes of hands-on use.

• Do you have any questions before we begin?

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