Transcript IRB介紹

The Recent Status of Institutional Review Boards
and Clinical Investigators in Medical Centers with
Well-Equipped General Clinical Research Center
Martin M-T Fuh MD, DMSci.
Institutional Review Board
China Medical University Hospital
China Medical University
Taichung, Taiwan, ROC
The IRB Forum
The IRB is and appropriately constituted group that has been
formally designated to review and monitor biomedical research
involving human subjects.
An IRB has the authority to approve, require modifications in (to
secure approval), or disapprove research.
This group review serves an important role in the protection of
the rights and welfare of human research subjects.
Human Protection in Human Research
What, Why, How, When and Where
The purpose of IRB review is to assure, both in advance
and by periodic review, that appropriate steps are taken
to protect the rights and welfare of humans participating
as subjects in the research.
IRBs use a group process to review research protocols and
related materials (e.g., informed consent documents and
investigator brochures) to ensure protection of the rights
and welfare of human subjects of research.
IRB Review Process
revised version
Martin M-T Fuh MD, DMSci.
新案/修訂案/延長試驗案
申請審查作業流程
人體試驗委員會
廠商/主持人
確認資料,收取費用並
開立收據
檢送申請案件,同時繳
交審查費用
快速審查約七天通過。
委員進行初審
回覆審查意見
一般審查平均約一個月通過
進入審查會議
委員複審
通過發予證明
存檔列管
稽查/定期追蹤
通報衛生署
Approval Letter
人體試驗委員會人體試驗計劃同意書
Tel: 886-4-22052121 ext: 4132
Fax: 886-4-2207-1478
中國醫藥大學附設醫院
台中市北區育德路 2 號
中國醫藥大學附設醫院○○科○○○○所提臨床試驗「○○○○○」之研究
案已獲同意。
計畫編號:○○○
本院編號:DMR96-IRB-○○
中國醫藥大學附設醫院人體試驗委員會已審查通過上述預計為期十二三十六
個月的研究案。
計劃有效期限到 2008 年 04 月 15 日為止。此計畫預訂執行期間自 2007 年 月
日至 2010 年 月 日,在有效期屆滿之前,研究計劃主持人應至少每年向人體試
驗委員會報告研究計劃的進行狀況。若屆時在尚未完成研究期間,每年應重新申請。
該計劃任何部分若欲更改,需向人體試驗委員會重新提出申請。計劃主持人對
受試者任何具有危險而且未能預期之問題,例如:對藥物、放射性元素或對醫療器
材產生不良反應等,需立即向人體試驗委員會主任委員提出書面報告。
主任委員
中
華
民
國
九
十
六
年
四
月
十
六
日
Approval Letter
The Institutional Review Board
China Medical University Hospital, Taichung, Taiwan
Tel: 886-4-22052121 ext: 4132
Fax: 886-4-2207-1478
Date:Apr. 16, 2007
Expedited Approval
To:○○○ , ○○ of ○○○,
China Medical University Hospital
From:Martin M-T Fuh MD, DMSci.
Chairman, Institutional Review Board
Subject:○○○○○
The Institutional Review Board has recommend the approval of the protocol number ○○
○; ICF version dated 3 April 2007; CMUH IRB No.: DMR96-IRB-○○○, date: Apr. 16,
2007, for the protocol identified above, and has determined that human subjects will be at risk.
Approval of your research project is, therefore, granted until Apr. 15, 2008 from Apr. 16,
2007 to Apr. 15, 2010. You are reminded that a change in protocol in this project requires its
resubmission to the Board. By the end of this annual period you may be asked to inform the
Board on the status of your project. If this has not been completed, you may request renewed
approval at that time.
Also, the principal investigator must report to the Chairman of the Institutional Review
Board promptly, and in writing, any unanticipated problems involving risks to the subjects of
others, such as adverse reactions to biological drugs, radio-isotopes or to medical devices.
Submission Note
中國醫藥大學附設醫院人體試驗委員會
Tel: 886-4-22052121 ext: 4132
Fax: 886-4-2207-1478
中國醫藥大學附設醫院
台中市北區育德路 2 號
茲收到中國醫藥大學附設醫院○○科(系)○○○主持人所提臨床試驗「○○○○○」之研
究案,此案正受理審查中。
本院編號:DMR96-IRB-○○
中
華
民
國
九
十
六
年
○
月
○
○
日
The Institutional Review Board
China Medical University Hospital, Taichung, Taiwan
Tel: 886-4-22052121 ext: 4132
Fax: 886-4-2207-1478
Date:mm. dd, yyyy
Submission Note
To:○○○ , ○○ of ○○○,
China Medical University Hospital
From:Martin M-T Fuh MD, DMSci.
Chairman, Institutional Review Board
Subject:○○○○○
We would like to inform you that your above-mentioned protocol has been received in the
Institutional Review Board Submission System. It has been forwarded to the Review Committee
on mm. dd, yyyy.
https://register.clinicaltrials.gov/
chinamuh
cmuh
cmuh66
View Protocol Record
Main Menu Select Preview Spelling Download XML Check Records
Record Status:
Released
In Progress | Completed | Approved | Released
Owned by: CMUH Last updated: 05/09/2007 14:32 by PRS_QA
Initial release: 05/08/2007 Last release: 05/09/2007 Download Receipt (PDF)
Comments:
Unique Protocol ID:
DMR96-IRB-41
Secondary IDs:
ClinicalTrials.gov ID:
NCT00471926
ClinicalTrials.gov Archive
Publication Status
Brief Title:
Diabetes Quality Improvement Program on Diabetes Case Management Program 2001 (DQIP-DCMP)
Official Title:
Diabetes Quality Improvement Program on Diabetes Case Management Program 2001
Study Type:
Observational
IND/IDE Protocol?
No
Sponsor:
China Medical University Hospital
Collaborators:
Review Board:
Approval Status: Approved
Approval Number: DMR96-IRB-41
Board Name: Institutional Review Board, China Medical University Hospital
Board Affiliation: China Medical University
Phone: 886-4-22062121 Email: [email protected]
Data Monitoring
Committee?
Yes
Oversight Authorities:
Taiwan: Department of Health
Brief Summary:
Detailed Description:
Record Verification Date:
May 2007
Overall Status:
Recruiting
Study Start Date:
April 2007
Last Follow-Up Date:
April 2008
Study Characteristics:
Primary Purpose: Natural History
Duration: Longitudinal
Selection: Defined Population
Timing: Retrospective/Prospective Study
Enrollment: 20000 [Anticipated]
Conditions:
Diabetes Mellitus
Keywords:
Diabetes Care
[Anticipated]
Interventions:
Eligibility Criteria:
Inclusion Criteria:
 All of Diabetes Cases
Gender:
Both
Minimum Age:
Maximum Age:
Accepts Healthy
Volunteers?
No
Central Contact:
Martin Fuh, MD, DMSci.
Telephone: 886-4-22062121 Ext. 4124
Email: [email protected]
Study
Officials/Investigators:
Martin Fuh, MD,DMSci Study Principal Investigator
[email protected]
Locations:
Martin M-T Fuh Taichung, Taiwan
Facility:
Martin
Fuh, MDSci Telephone: 886-4-22062121 Ext.
Contact:
4124
Email: [email protected]
Investigator: Martin Fuh, MD,DMSci
Role: Principal Investigator
Recruitment Status: Recruiting
Martin M-T Fuh Taichung, Taiwan
Facility:
Contact: Martin Fuh, MDSci
Telephone: 886-4-22062121 Ext. 4124
Email: [email protected]
Martin
Fuh,
MD,DMSci
Role:
Principal Investigator
Investigator:
Recruitment Status: Recruiting
Citations:
Links:
Main Menu Select Preview Spelling Download XML Check Records
The Institutional
Review Board
Forum
What is expedited review?
Expedited review is a procedure through which
certain kinds of research may be reviewed and
approved without convening a meeting of the IRB.
The Agency's IRB regulations [21 CFR 56.110]
permit, but do not require, an IRB to review
certain categories of research through an
expedited procedure if the research involves no
more than minimal risk.
The Institutional
Review Board Forum
What is expedited review?
The IRB may also use the expedited review procedure to
review minor changes in previously approved research
during the period covered by the original approval. Under
an expedited review procedure, review of research may
be carried out by the IRB chairperson or by one or more
experienced members of the IRB designated by the
chairperson. The reviewer(s) may exercise all the
authorities of the IRB, except disapproval. Research may
only be disapproved following review by the full
committee. The IRB is required to adopt a method of
keeping all members advised of research studies that
have been approved by expedited review.
The Institutional
Review Board Forum
CRITERIA FOR QUALIFYING FOR A FAST TRACK
DRUG DEVELOPMENT PROGRAM
A. Serious or Life-Threatening Condition
1. Whether a condition is serious
2. Whether the drug is intended to
treat a serious condition
The Institutional
Review Board Forum
CRITERIA FOR QUALIFYING FOR A FAST
TRACK DRUG DEVELOPMENT PROGRAM
B. Demonstrating the Potential to Address
Unmet Medical Needs
1. Evaluation of whether the drug
development plan addresses unmet
medical needs
2. Demonstration of the drug's potential
The Institutional
Review Board Forum
THE SELF-MONITORING ASSESSMENT PROGRAM FOR
IRB CONTINUOUS QUALITY IMPROVEMENT (CQI)