UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052134 |
|---|---|
| Receipt number | R000059277 |
| Scientific Title | Original Scoring of Safety Reports for Improving Medical Security -Trajectory for 18 years at a single center- |
| Date of disclosure of the study information | 2023/09/15 |
| Last modified on | 2024/09/08 16:22:48 |
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Basic information
Public title
Original Scoring of Safety Reports for Improving Medical Security
-Trajectory for 18 years at a single center-
Acronym
Original scoring of medical safety reports
Scientific Title
Original Scoring of Safety Reports for Improving Medical Security
-Trajectory for 18 years at a single center-
Scientific Title:Acronym
Original scoring of medical safety reports
Region
| Japan |
Condition
Condition
All diseases
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate usefulness of the management score which was originally developed by JA Toride Medical Center
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The total score (risk score x management score)
Key secondary outcomes
Number of reports, the risk score, the management score
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Total reports
Key exclusion criteria
Incomplete data
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Maeda |
Organization
JA Toride Medical Center
Division name
The Safety Control Section
Zip code
3020022
Address
2-1-1 Hongo, Toride, Ibaraki, Japan
TEL
81297745551
yoshimaeda43@toride-medical.or.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Maeda |
Organization
JA Toride Medical Center
Division name
The Safety Control Section
Zip code
3020022
Address
2-1-1 Hongo, Toride, Ibaraki, Japan
TEL
81297745551
Homepage URL
yoshimaeda43@yahoo.co.jp
Sponsor or person
Institute
JA Toride Medical Center
Institute
Department
Personal name
Yoshitaka Maeda
Funding Source
Organization
JA Toride Medical Center
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
The ethical committee, JA Toride Medical Center
Address
2-1-1 Hongo, Toride, Ibaraki, Japan
Tel
81297745551
syomukacho@toride-medical.or.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
JAとりで総合医療センター
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 15 | 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
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Retrospective observational analysis of medical safety reports with originally developed management scores between 2012 and 2022.
Management information
Registered date
| 2023 | Year | 09 | Month | 07 | Day |
Last modified on
| 2024 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059277
