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HUlI lAN ETHICS COMMITTEE

February 9,2012

To,Dr. TejpalGuPta,Principal Investigator,ACTREC

Ref: Final Approval -Project No' 954

Dear Dr. GuPta,

Human Ethics committeerl reviewed and discussed your apprication dated 04.10.2011 to conduct the

research study entifled'iArr.rrr.nt of comJtian.. it tr..trent, disease outcomes, and quality'of'

life in patients *ith ;;;i.g..*.igF;i. gligll treated with continuous short'course

hypofractionated radiation-tfi.",i,V tSXOnit;-Ounng tiqHEC-ll lryting held on 02122011at 8'30 a'm'

in the Institutiona neJiew ao.rj fird.ting nl,"r, u".i. Bldg.,3d Floor, Tata Memorial Hospital'

The following documents were reviewed:

1. Project Submission Form

2. TMC-scientific Review Commiftee approval dated 12'10'201 1 '

3 'C| in ica|studyProtoco|(SHORT)version1.0dated02.09.2011

4. Case report form (SHORT) v1'0 dated 01'09'2011

5'EoRTcQL0-C30&BN.20version3.0inEng| ish,Hindi ,Marathi

6. FACT Brain version 4 in English

7 . CVs of Principal Investigator & Co-investigators

At the Human Ethics committee meeting herd on 02.12.2011 the above mentioned documents were

examined and dtscusJeo. nttriconsideration, iic qutry letter dated 16.12'2011was issued'

WereceivedHECqueryresponse|et terdated27.o1.2o12a|ongwiththebe|owment ioneddocuments*ni.n *.t reviewed and approved on 09'02'2012'

1. InformedConsentFormversion3.0dated25.0l ,20l2inEng| ish,Hindi ,Marathi

2. Budget sheet dated 27 '01'2012'

The following members of the Human Ethics committee-ll (HEc-ll) were present at the meeting held on

o2.1z.zo11at g.30 a.m. in the Institutio..in.ri.* Board Meeting Room, Main Bldg', 3'o Floor' Tata

Memorial HosPital.

Final APProval of Project N0 954Page 1 of 3

E-mail : tmhethics@ gmail.com\Alohei ta ' ht to: / / tmc.oov. in

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Senior Consultant,Histopathologist, Prince AIY Khan

2. Dr. Medha Joshi,Member Secretary

Head, Digital Lib. Scs., TataMemorial Hospital

Female Library Information Sc.SocialScientist

3. Dr. R. Munagekar,Member

Pathologist and MedicolegalConsultant, Sadhana PathologyLaboratorv

Male Medicolegal expert

4. Dr, RatiGodrej,Member

Physician, US Consulate, LincolrHouse

Female Physician

5. Mr, P, K, Rao,Member

Founder/ Trustee of JASCAP,Jeet Association for support toCancer oatients since 1996

Male Lay Person

6. Dr, SarbaniGhoshMember

Associate Prcfessor, Dept. ofRadiation Oncology, TMH,Secretary, Data Safety andlrbnitodng subcommiftee, TMH

Female Radiation Oncologist

7. Dr. VaniParmar,Itlember

Associate Pmbssor & Surgeon,Dept. of Sumery, TMH

Female Surgeon

8. Dr. M.A Muckaden,Member

Radiation Oncologist,O/lC Palliative CaG Services.TMC

Female Radiation Oncologist

9. Dr. Sandeep Tandon,illember

Associate Prcfussor, Dept ofPulmonary lvlediine, Tl,lH

Male Clinician

1CDr. Viknam GSMember

Clinbal Pharmacologist,ACTREC

Male ClinicalPharmacolooist

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

Following points must be noted:

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

2. HEG has approved recruitment of 55 patients on the study.

3. Pl and other investigaton should cooperate fully witt data and safety monitoring sub-committee(DSMSC), who will monitorthe trialfrom time to time.

4. The decision was anived at through consensus. Neitrer Pl nor any of proposed study teammembens was present during the decision making of the HEC

At the time of Pl's retiremenUintention to leave the institute, study responsibility should betransfened to colleague after obtaining cleanance from HOD, Status report, including accountsdetails should be submitted to HOD, DSMSC and extramuralsponsors.

The HEC functions in accordance with the ICH-GCP/CMR/Schedule Y guidelines,

In case of any new information or any SAE, which could affect any study, must be informed toHEC, DSMSC and sponsors. The Pl should report SAEs occurred for HEC approved studies within

Final Approval of Project No. 954Page 2 of 3

o.

7,

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7 days of the occurrence of the SAE. lf fie SAE is 'Death', the IRB Secretariat will receive the SAEreporting form within 24 houns of the occurence.

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

a. The exact alteration/amendment shouH be specified and indicated where theamendment occuned in the original poirt (Page no. Clause no. etc.)

b. Alteration in the budgetary status should be cbarly indicated and the revised budget formshould be submifted

c. lf the amendments require a change in the consent form, the copy of revised ConsentForm should be submifted to Etrics Commifieeforapproval.

d. lf the amendment demands a elook d he bxicig or side effects to patients, the sameshouH be documented.

e. lf frpre arc any amendmenb in the Eid design, hese must be incorporated in theptobcol, and ofier sfuly docutnettb. These evised documents should be submitted forapproval of tp SRC and HEC, only hen can hey be implemented.Approval for arflgndment changes must be obtained pdor to implemenhtion of changes.mn {ote ap,proved bytheEthics commiftee.Any deviationfuiolation/waiverin the pmtool mrst be inbmed to tre HEC.

Thanking You,

Member Secretary,Institutional Review Board.ll

Final Approval of Project No. 954Page 3 of 3