Tokyo, Sept. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058692) titled 'Study on efficient reporting of protocol deviations in clinical trials using generative AI' on Sept. 1.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - Okayama University
Condition:
Condition - none
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - In clinical trials, CRC shortages increase workload and affect quality. Generative AI may support documentation by non-medical personnel. This study evaluates how medical qualification and AI support affect the quality, efficiency, and burden of writing deviation reports.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - First report created without AI support; second with AI support.
Interventions/Control_2 - First report created with AI support; second without AI support.
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key 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
Key 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)
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 06 Month 16 Day
Anticipated trial start date - 2025 Year 09 Month 01 Day
Last follow-up date - 2025 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066989
Disclaimer: Curated by HT Syndication.
