UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027406
Receipt number R000031408
Scientific Title Survey on incidents of Generic Drugs at Tohok University Hospital.
Date of disclosure of the study information 2017/05/20
Last modified on 2018/05/21 08:55:14

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Basic information

Public title

Survey on incidents of Generic Drugs at Tohok University Hospital.

Acronym

Survey on incidents of Generic Drugs.

Scientific Title

Survey on incidents of Generic Drugs at Tohok University Hospital.

Scientific Title:Acronym

Survey on incidents of Generic Drugs.

Region

Japan


Condition

Condition

Drug-related incident reports submitted in 2016 fiscal-year.

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We study drug incidents related to generic drugs at our hospital from the incident reports and grasp the current situation. We aim to check what ways are being taken now and what ways should be take in the future.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The effectiveness of the currently implemented measures.

Key secondary outcomes

Difference between incidents of generic medicine and original medicine.


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

Drug-related Incident Report in FY 2016

Key exclusion criteria

Those who refused to participate.

Target sample size

1200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masao Tabata

Organization

Tohoku University

Division name

Department of Occupational Health, Graduate School of Medicine

Zip code


Address

2-1, Seiryo-machi, Aoba-ku, Sendai 980-8575 Japan

TEL

022-717-7874

Email

tabata@med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masao Tabata

Organization

Tohoku University

Division name

Department of Occupational Health, Graduate School of Medicine

Zip code


Address

2-1, Seiryo-machi, Aoba-ku, Sendai 980-8575 Japan

TEL

022-717-7874

Homepage URL


Email

tabata@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Tohoku University

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


Address


Tel


Email



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

2017 Year 05 Month 20 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

2017 Year 05 Month 19 Day

Date of IRB


Anticipated trial start date

2017 Year 06 Month 26 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Investigate the name of the drug that caused the incident and consider whether it is a generic drug or not.
From the submitted drug-related incident reports, investigate at which stage errors occurred and consider effective way of avoiding insidents.


Management information

Registered date

2017 Year 05 Month 19 Day

Last modified on

2018 Year 05 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031408


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name