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IRB OtJiceDr. E. Borges Marg, Parel,Mumbai - 400 012. IndiaPhone : 022'2417 7262caw .AcD-92 9il4 A937
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