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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041087
Receipt No. R000046923
Scientific Title Retrospective observational study of incident reporting data
Date of disclosure of the study information 2020/07/13
Last modified on 2020/07/13

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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
Email 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
Email nakiyama@iwate-med.ac.jp

Sponsor
Institute Iwate Medical University
Institute
Department

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
Email 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 Open public recruiting
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
2031 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 (2007-2025) will be collected retrospectively as a collection of existing materials.

Management information
Registered date
2020 Year 07 Month 13 Day
Last modified on
2020 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.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


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