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.
Make sure the section regarding potential risks has been read out loud to the participant.
Make sure that the participant has signed the ICF.
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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File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
Author | Shannon Clark |
File Modified | 0000-00-00 |
File Created | 2022-06-06 |