Attachment 6E2 Tianjin Tumor Hospital Medial IRB approval - English

Institutional Review Board of Tianjin Tumor Hospital

Approval Letter from Institutional Review Board

Document ID: E2014085

Project Summary:

Project Title: A multi-center international hospital-based case-control study of lymphoma in Asia

Principal Investigator: Kexin Chen

Project Initiator: National Cancer Institute

Approval Content:

1. Study protocol in Chinese (Version: 2.0, date: July 4, 2014)

2. Study protocol in English (Version: 2.0, date: July 4, 2014)

3. Consent form (Version: 2.0, date: July 4, 2014)

Vote Result:

Total votes: 11; Agreed votes: 11; Agreed after necessary revision: 0; Disagree: 0.

Review Conclusion:

After reviewing, the IRB approves the project entitled “A multi-center international hospital-based case-control study of lymphoma in Asia” to be continuing in our hospital.

Signature of IRB Chair (or the Agent):

(Seal of IRB, Tianjin Tumor Hospital)

Institutional Review Board of Tianjin Tumor Hospital

July 11, 2014

The IRB requests the investigators to strictly stick to the approved project protocol and informed consents to conduct the study. Any revision on the project protocol and informed consents shall be informed to the IRB in timely manner to be re-reviewed before continuing of the study.

Address: Building C6, Tianjin Tumor Hospital, Huanhu West Road, Tianjin, 300060

Tel: (022) 23340123-6012 Fax: (022) 23524155

Email: ec_tjcih@126.com

Institutional Review Board of Tianjin Tumor Hospital

Participants of the IRB

Project Title: A multi-center international hospital-based case-control study of lymphoma in Asia

Principal Investigator: Kexin Chen

Project Initiator: National Cancer Institute

Members of the IRB

Name	Sex	IRB Title	Specialty	Work Title	Institute	Signature	Date
Ming Gao	M	Chair	Tumor Surgery	Vice Director	Tianjin Tumor Hospital
Ying Wang	F	Member	Translator	secretary general	Chinese Anti-Cancer Association
Yongqin Jiang	F	Member	Nursing	Senior Nurse	Tianjin Tumor Hospital
Han Liang	M	Member	Tumor Surgery	Physician	Tianjin Tumor Hospital
Chen Wang	F	Member	Medication	Pharmacist	Tianjin Tumor Hospital
Kexin Chen	F	Member	Epidemiology	Investigator	Tianjin Tumor Hospital
Li Wei	F	Member	Lawyer	Senior lawyer	Tianjin Linyu Law Office
Xuehong Ma	M	Member	Management	Director of training department	Tianjin Training Base of Hebei Business Bureau
Tianqiang Song	M	Member	Tumor Surgery	Physician	Tianjin Tumor Hospital
Peifang Liu	F	Member	Medical Image	Physician	Tianjin Tumor Hospital
Peng Chen	M	Member	Tumor internal medicine	Assistant physician	Tianjin Tumor Hospital
Huilai Zhang	M	Member	Tumor internal medicine	Assistant physician	Tianjin Tumor Hospital

The constitution and operation of the IRB follow the Good Clinical Practice issued by China's State Drug Administration in 2003 and principle of Declaration of Helsinki and International Ethical Guidelines for Biomedical Research released by Council for International Organizations of Medical Sciences (CIOMS).

Address: Building C6, Tianjin Tumor Hospital, Huanhu West Road, Tianjin, 300060

Tel: (022) 23340123-6012 Fax: (022) 23524155

Email: ec_tjcih@126.com

Institutional Review Board of Tianjin Tumor Hospital

Appendix 1:

Declaration of affiliation with GCP

This IRB is an independent board, whose constitution and operation follow the requirements from ICH-GCP, GCP and relative law. All members of the IRB are within the valid duty of their careers.

Address: Building C6, Tianjin Tumor Hospital, Huanhu West Road, Tianjin, 300060

Tel: (022) 23340123-6012 Fax: (022) 23524155

Email: ec_tjcih@126.com