UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041087 |
|---|---|
| Receipt number | R000046923 |
| Scientific Title | Retrospective observational study of incident reporting data |
| Date of disclosure of the study information | 2020/07/13 |
| Last modified on | 2021/10/20 09:21:26 |
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Basic information
Public title
Retrospective observational study of incidents
Acronym
Study of incidents
Scientific Title
Retrospective observational study of incident reporting data
Scientific Title:Acronym
Retrospective observational study
Region
| Japan |
Condition
Condition
incident
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of factors related to the occurrence of incidents
Basic objectives2
Others
Basic objectives -Others
Development of education/monitoring tools considering the risk of incidents
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Factors related to the occurrence of incidents
Key secondary outcomes
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
All of the reports reported to the medical safety management department for 20 years (2007 to 2025),with consent regarding the use of data
Key exclusion criteria
The blanks in the report are 80% or more.
The type of job involved in the report is not clear.
Target sample size
100000
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Koeda |
Organization
Iwate Medical University
Division name
Department of Medical Safety Science
Zip code
028-3695
Address
2-1-1 Idaidori, Yahabacho, Shiwagun, Iwate
TEL
0196137111
keikoeda@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | Akiyama |
| Last name | Akiyama |
Organization
Iwate Medical University
Division name
Department of Medical Safety Science
Zip code
028-3695
Address
2-1-1 Idaidori, Yahabacho, Shiwagun, Iwate
TEL
0196137111
Homepage URL
nakiyama@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committees of Iwate Medical University
Address
2-1-1 Idaidori, Yahabacho, Shiwagun, Iwate
Tel
0196137111
kenkyu@j.iwate-med.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
| 2020 | Year | 07 | Month | 13 | 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
| 2018 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The reports and hospital data (Data Ware House) reported to the Medical Safety Promotion Office for 20 years (2007-2022) will be collected retrospectively as a collection of existing materials.
Management information
Registered date
| 2020 | Year | 07 | Month | 13 | Day |
Last modified on
| 2021 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046923
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
