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HUMAN ETHICS COMMITTEE

January 19, 2011To,Dr. Vanita Noronha,Principal Investigator,TMH

Ref: Final Approval -Project No. 937

Dear Dr. Noronha,

Human Ethics Committee-I reviewed and discussed your application dated 09.08.2011 to conduct theresearch study entitled "Phase III non-inferiority randomized trial comparing three-weekly Cisplatinversus weekly Cisplatin in combination with radiation therapy in patients with advanced carcinomaof the head and neck" during the HEC-I meeting held on 25.11.2011 at 8:30 a.m. in the InstitutionalReview Board Meeting Room, Main Bldg., 3rd Floor, Tata Memorial Hospital.

The following documents were reviewed:

1. Project Submission form.2. TMC-Scientific Review Committee approval dated 14.09.20113. Clinical Study Protocol version 1 Dated 01/06/2011.4. Patient Information Sheet & Informed Consent Form:

Language: English, version 1 dated 01/Jun/2011.5. Case Report Forms version 1 Dated 27/06/2011.6. EORTC QLQ-C30: languages: English, Hindi, Marathi, Bengali Version 3.7. EORTC HN35: languages: English, Hindi, Marathi, Bengali8. Curriculum vitae of Principal Investigator and Co-investigators.

At the Human Ethics Committee meeting held on 25.11.2011 the above mentioned documents wereexamined and discussed. After consideration, the committee had suggested changes and HEC query letterdated 13.12.2011 was issued.

We received HEC query response letter dated 28.12.2011 along with the below mentioned documents withthe suggested changes which were reviewed and approved on 12.01.2012

• Detailed Budget Sheet• Patient Information Sheet & Informed Consent Form in Hindi and Marathi Version 2 dated

27.12.2011

The following members of the Human Ethics committee-I (HEC-I) were present at the meeting held on25.11.2011 at 8.30 a.m. in the Institutional Review Board Meeting Room, Main Bldg., 3rd Floor, TataMemorial Hospital.

Sr. No. Names Affiliation Gender Expertise1. Dr. Tapan Saikia, Medical Oncologist, Prince Male Medical

Acting Chairperson Aly Khan Hospital Oncologist2. Dr. J. V. Divatia Professor, Head Dept. of Male Anaesthetist

IRB OfficeDr. E. Borges Marg. Parel.Mumbai - 400 012. IndiaPhone: 022-2417 7262Fax:022-22 2414 6937

Final Approval of Project No. 937Page 1 of 3 3lTU 3TR <It ~

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Member Secretary Anaesthesia, TataMemorial Hospital

3. Dr. N. Gogtay, Associate Professor, Clinical Female ClinicalMember Pharmacoloqv, KEM Hospital Pharmacologist

4. Dr. Pradnya Talawadekar, Project Manager of Ojus Female Legal expertMember Medical Institute, Juhu.

5. Ms. Viji Venkatesh, Head, Max Station India & Female Lay personMember Asia Pacific Region Co

ordinator6. Ms. Mrunal Marathe, Medical Counselor Female Social scientist

Member7. Dr. HKV Narayan, Medical Superintendent, Male Medical

Member TMH Superintendent8. Dr. Tanuja Shet, Professor, Dept. of Female Pathologist

Member Pathology, TMH9. Dr. Manju Sengar, Associate Professor & Female Medical Oncologist

Member Medical Oncologist, TMH10. Dr. S. N. Myatra, Associate Professor, Dept. Female Anaesthetist

Member of Anesthesia, TMH and Jt.Secretary, Data Safety andMonitoring subcommittee,Tata Memorial Hospital.

11. Dr. A. Lobo Gajiwala, Head, Dept. of Tissue Bank, Female Social ScientistMember Tata Memorial Hospital

The study is approved in its presented form. The approval is valid until one year from the date ofsanction. You may make a written request for renewal I extension of the validity, along with thesubmission of annual status report. The study should be initiated only after registration of the studywith Clinical Trials Registry India (CTRI).

FOllowing points must be noted:,

1. HEC should be informed of the yearly progress of the study.

2. HEC has approved recruitment of 300 subjects on the study.

3. PI and other investigators should co-operate fully with data and safety monitoring sub-committee(DSMSC), who will monitor the trial from time to time.

4. The decision was arrived at through consensus. Neither PI nor any of proposed study teammembers was present during the decision making of the HEC.

5. At the time of PI's retirement/intention to leave the institute, study responsibility should betransferred to colleague after obtaining clearance from HOD, Status report, including accountsdetails should be submitted to HOD, DSMSC and extramural sponsors.

6. The HEC functions in accordance with the ICH-GCP/ICMRISchedule Y guidelines.

Final Approval of Project No. 937Page 2 of 3

7. In case of any new information or any SAE, which could affect any study, must be informed toHEC, DSMSC and sponsors. The PI should report SAEs occurred for HEC approved studies within7 days of the occurrence of the SAE. If the SAE is 'Death', the IRS Secretariat will receive the SAEreporting form within 24 hours of the occurrence.

8. In the events of any protocol amendments, HEC must be informed and the amendments should behighlighted in clear terms as follows:

a. The exact alteration/amendment should be specified and indicated where theamendment occurred in the original project. (Page no. Clause no. etc.)

b. Alteration in the budgetary status should be clearly indicated and the revised budget formshould be submitted

c. If the amendments require a change in the consent form, the copy of revised ConsentForm should be submitted to Ethics Committee for approval.

d. If the amendment demands a re-Iook at the toxicity or side effects to patients, the sameshould be documented.

e. If there are any amendments in the trial design, these must be incorporated in theprotocol, and other study documents. These revised documents should be submitted forapproval of the SRC and HEC, only then can they be implemented.

f. Approval for amendment changes must be obtained prior to implementation of changes.Without including all the above points, the amendment is unlikely to be approved by theEthics committee.

g. Any deviation/violation/waiver in the protocol must be informed to the HEC.

Thanking You,

Yours Sincerely,

p .J. V. Divatia,Member Secretary,Human Ethics Cornmittee-l

Final Approval of Project No. 937Page 3 of 3