UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058692 |
|---|---|
| Receipt number | R000066989 |
| Scientific Title | Study on efficient reporting of protocol deviations in clinical trials using generative AI |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/08/01 16:14:42 |
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Basic information
Public title
Study on efficient reporting of protocol deviations in clinical trials using generative AI
Acronym
Deviation Reporting AI Study
Scientific Title
Study on efficient reporting of protocol deviations in clinical trials using generative AI
Scientific Title:Acronym
Deviation Reporting AI Study
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Quality score of the reports based on blinded evaluation by three raters
Key secondary outcomes
- 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
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 80 | 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 sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshito |
| Middle name | |
| Last name | Zamami |
Organization
Okayama University Hospital
Division name
Department of Pharmacy
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama 700-8558, Japan
TEL
086-235-7640
zamami-y@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kuroda |
Organization
Okayama University Hospital
Division name
Department of Pharmacy / Center for Innovative Clinical Medicine
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama 700-8558, Japan
TEL
086-235-6122
Homepage URL
kuroda-s@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama 700-8558, Japan
Tel
086-235-6503
mae6605@adm.okayama-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 04 | Day |
Last modified on
| 2025 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066989
