UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of the "Adverse Drug Reaction Monitoring System " using high- performance communication mobile
Title of the study (Brief title)	Development of the "Adverse Drug Reaction Monitoring System "
Region	Japan

Condition
Condition	It does not matter disease
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Development of the "Adverse Drug Reaction Monitoring System " using high- performance communication mobile
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Development of the "Adverse Drug Reaction Monitoring System " using high- performance communication mobile
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	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	use of high\peformance communication mobile
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	0 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	patient using high performance comminication mobile
Key exclusion criteria	non consent patient
Target sample size	150

Research contact person
Name of lead principal investigator	Hiroyuki Furukawa
Organization	Yamaguchi University Hospital
Division name	Department of Pharmacy
Address	1-1-1, Minamikogushi, Ube-city
TEL	0836-22-2665
Email	sambista-knz@umin.ac.jp

Public contact
Name of contact person	Hiroyuki Furukawa
Organization	Yamaguchi University Hospital
Division name	DEpartment of Pharmacy
Address	1-1-1, Minamikogushi, Ube-city
TEL	0836-22-2665
Homepage URL
Email	sambista-knz@umin.ac.jp

Sponsor
Institute	Yamaguchi University Hospital
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	Yamaguchi University Hospital
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	2016 Year 04 Month 12 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 12 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

Management information
Registered date	2016 Year 04 Month 12 Day
Last modified on	2016 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023547