Attach 6E2 - Dalin Tsu-Chi Hospital_IRB_English

Attach 6E2 - Dalin Tsu-Chi Hospital_IRB_English.doc

A multi-center international hospital-based case-control study of lymphoma in Asia (AsiaLymph) (NCI)

Attach 6E2 - Dalin Tsu-Chi Hospital_IRB_English

OMB: 0925-0654

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Office-head letter of Buddhist Dalin Tzu Chi General Hospital


IRB of Buddhist Dalin Tzu Chi General Hospital

Notification Letter of Review Result


Full title of project, version (including revised) and date

Title: “A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia(AsiaLymph): Taiwan Study Center”

IRB number: A10004003

Version: Oct. 30, Minguo 101 version of the IRB

Title of other review documents, version(including revised) and date

Informed consent form related to genetic subjects: Jan. 18, Minguo 101 of the IRB

Informed consent form: Jan. 18, Minguo 101 of the IRB

Principal Investigator

Yu-chieh Su

Approval date and place

Feb. 20, Minguo 101, IRB of Buddhist Dalin Tzu Chi General Hospital

Performance period and content

The performance period of “A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia(AsiaLymph): Taiwan Study Center”, the PI is Yu-chieh Su, will be Feb. 20, Minguo 101 to Feb. 19, Minguo 103 (about 3 years). The estimated enrolled subjects will be 180.

Active period of the approval

Feb. 20, Minguo 101 to Feb. 28, Minguo 102

Other additional suggestions

Periodic follow up review will be required, and will inform one week before the performance date. Please be cooperative at that time regarding the follow up review.

Regular follow-up process and requirement

In the middle of the project or when more than half of the subjects are enrolled, please provide mid-term report actively (it estimates that mid-term reports need to be submitted at the end of February of Minguo 102, and at the end of February of Minguo 103). A conclusion report is required to be submitted actively within two months after the completion of this project (It estimates that conclusion report will be submitted at the end of April of Minguo 104). No new project should be applied if this project does not be completed. If the project halts for some reason, a halt-report should be submitted actively within two months it happens.

Contacting window

If there is any questions, please contact the IRB.

Tel: 05-2648000 ext: 5908 Fax: 05-2648000 ext:5916 Email: irb_DL@tzuchi.com.tw or mail to IRB of Dalin Tzu Chi General Hospital, 2, Min-Sheng Road, Dalin Town, Chia-Yi Taiwan R.O.C (622)

Chairman/Agency

Signed

Formally Released on Feb. 20, Minguo 101(2012)

Office-head letter of Buddhist Dalin Tzu Chi General Hospital




Approval Letter of agreement on clinical trail


This letter is to confirm that the project “A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia(AsiaLymph): Taiwan Study Center” submitted by Dr. Yu-chieh Su has been approved by the Institutional Review Board of our hospital after reviewing. Our IRB fulfills and abides by the Regulation on Human Research released on December 28, Minguo 100.


IRB of Dalin Tzu Chi General Hospital

Chairman

Feb. 20, Minguo 101 (Feb. 20, 2012)

File Typeapplication/msword
File Title大林慈濟醫院臨床研究計畫初審結果通知
AuthorUser
File Modified2012-02-22
File Created2012-02-22

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