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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014076
Receipt No. R000016384
Official scientific title of the study Developing Investigator-initiated Clinical Research protocol.
Date of disclosure of the study information 2014/05/28
Last modified on 2014/05/26

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Basic information
Official scientific title of the study Developing Investigator-initiated Clinical Research protocol.
Title of the study (Brief title) Developing Investigator-initiated Clinical Research protocol.
Region
Japan

Condition
Condition protocol
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The quality evaluation of investigator-initiated clinical trial protocols
Basic objectives2 Others
Basic objectives -Others Developing how to improve protocol.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Not specified
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. clinical trials consulter on the Tokyo women's hospital 2.not yet passed a review of the ethics committee 3. investigator-initiated clinical trial 4. receiving a full explanation Upon participation in the study, on a full understanding, the resulting document voluntary consent
Key exclusion criteria 1, clinical experience trial. 2, company initiated trial. 3, no consent 4, judged disqualification
Target sample size

Research contact person
Name of lead principal investigator Atsushi Aruga
Organization Joint Graduate School of Tokyo Women's Medical University and Waseda University
Division name Cooperative Major in Advanced Biomedical Scienccces Institute of Advanced Biomedical Engineering and Science
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-5367-9945
Email aruga6638@gmail.com

Public contact
Name of contact person Masaya goto
Organization Joint Graduate School of Tokyo Women's Medical University and Waseda University
Division name Cooperative Major in Advanced Biomedical Scienccces Institute of Advanced Biomedical Engineering and
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL 09035540449
Homepage URL
Email masaya1984j_med@yahoo.co.jp

Sponsor
Institute Joint Graduate School of Tokyo Women's Medical University and Waseda University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Joint Graduate School of Tokyo Women's Medical University and Waseda University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2014 Year 05 Month 28 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2014 Year 03 Month 11 Day
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information One year after consent

Management information
Registered date
2014 Year 05 Month 26 Day
Last modified on
2014 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016384


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