none
Conditions
Interventions
First report created without AI support
second with AI support.
First report created with AI support
second without AI support.
Sponsors
Okayama University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Employees of Okayama University Hospital or SMO 2. Some experience in clinical trial or research-related duties (medical or administrative) 3. Able to operate a computer and create documents in Japanese 4. Capable of understanding the study purpose and providing written informed consent 5. Aged >=18 and <80 years at the time of consent
Exclusion criteria
Exclusion criteria: 1. Those with advanced experience using generative AI that may bias the evaluation 2. Those deemed unable to participate due to mental or physical burden (based on self-report)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality score of the reports based on blinded evaluation by three raters | — |
Secondary
| Measure | Time frame |
|---|---|
| - Time required for report preparation - Self-assessed task burden - Participant evaluation of similarity to real-world protocol deviation records - Free-text and multiple-choice responses on perceived usefulness and usability of generative AI | — |
Countries
Japan
Contacts
Public ContactSatoshi Kuroda
Okayama University Hospital Department of Pharmacy / Center for Innovative Clinical Medicine
Outcome results
None listed