Initial Training Script

Data To Support Social and Behavioral Research as Used by the Food and Drug Administration

Initial Training Script

OMB: 0910-0847

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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.



  1. 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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