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Shatabdi Hospital Ethics CommitteeDr. Mrs. Me6nal Mohgaonkar, [.tDChairperson

Dr. Nitin Ghaisas, [.rDMember S€crelary

Date: 08 March 2012

ToDr. Nit in Ghaisas,Principal I nvesligalor.Shatabdi Superspecial i ty Hospital,Suyoji t City Cenlre,Opp Mahamarg Bus Stand,Mumbai Naka, Nashik 422005.

Protocol Number: AMR-01-01 -001 9

EC Reference No: EC/Pharma,i20l2-02,4.iC

Tit le: A Mult i-center, Prospective, Randomised, Double-bl ind, Placebo-Control led, Paral lel-Group Study to Evaluate the Eflecl of A MR I 0l on Cardiovascular Health and Monality inHyperir iglyceridemic Patients with Cardiovascular Disease or at High Risk for CardiovascularDisease: REDUCE-lT (Reduction of Card iovascu lar Events with EPA-lntervention Trial).

Subject: Ethics Committee approval for thc conduct ofthe referenced study under your directionat "Shatabdi Superspecial i ty Hospital. Nashik" and approval oistudy related documents.

Dear Dr. Nit in Ghaisas,This is in relerence to submission lefter dated l5 Feb 2012 & 0l March 20l2.The ShatabdiHospital Ethics Committee (SHEC) reviewed and discussed your application for approval forconduct ofthe study and study related documents.

The fol lou ints documents u ere re, ' ieu ed:. Amafin AMR-01-01-0019 REDUCE lT FINAL PROTOCOL_ VERSION 1.0-02 AUG

2 0 | .r Subject Information Sheet and Inforrred Consent Form in English-AMR-01-01-

0019 ICF F ina l Ve rs ion L0 ,06 Oc t 201 l / l nd ia Ve rs ion l . l 02 Feb 2012 .. Subject Inlormation Sheet and Intbrmed Consent Form in English-AMR-01-01-

0019_ lCF F ina l Ve rs ion 1 .0 ,06Oc t2011 / lnd iaVers ion l . l 02 Feb 2012 T rans la ted f romEnglish to Marathi Dated I I Feb 2012.

SUPER SPECIALITY H(lSPITTAT

Page I of'l

SUYOJIT CIry CENTRE, OPP. MAHAMARG BUS STAND, I\,IUI\,IBAI NAKA, NASHIK422 OOs'PH.0253 6639001

Sahyadd Seva Health Care Pvt, Ltd.'s

Shatabdi Hospital Ethics Committee

SahyadriSeva Health Care Pvt. Ltd,h

9ratabdiSUPER SPECIALITY H()SPITIAL

Dr. Mrs. Meenal Mohgaonkar, [,aDChaircerson

Dr. Nitin Ghaisas, [,lD[,4ember Secretary

. Translation Certi f icate: (Translarion English to Marathi) Dated l5 Feb 2012.

. Subject Information Sheet and Informed Consent Form in Enelish_AMR_O1_01_0019 ICF F ina l Ve rs ion l .0 ,06Ocr20 | / t nd iaVers ion l . t 02Feb20 t iBackTrans la redfrom Marathi to English Dared l l Feb 2012.

. Translation Certi f icatet ( Back Translation form Marathito English) Datecl:15 Feb20l2

. Subject Informarion Sheet and Inlormed Consent Form in Enelish,AMR-01_01_0019 ICF Final Version l.0.06 Oct 20l l / lndia Version LI 02 Feb 20i2 Translared fromEng l i sh to H ind i Da ted l l Feb 2012 .

. Translation Certi f icate: ( Translarion English ro Hjndi) Dated l5 Feb 20 t2.

. Subject Information Sheet and Inlormed Consent Form in English_AMR_01_01-0019_lCFFinal Version L0, 06 Oct 201 l/ tndia Version l. l 02 Feb 20li tsack I ranslatedfrom Mararhi ro English Dared l l Feb 2012.

. Translation Certi t lcate: (Back Translated form Hindi to English) Dated: i5 Feb20l2.

. lnvestigator Brochur.e Edir ion 3.0 l9 Oct 201 I

. Samp le Ca ,e Repon I o rm rAVR-01-0 t -00 tq -CRt \ \ 4 tTADAl A _20 Jan 2012 ,

. Insurance Certi f icate Effective from November 29,2011 ro November 2g,2015 (policynumber :4067 08262202 00 000 )

o DCGI SLrbmission Lerter dared 29 Dec 201 I. Appoinrment Reminder (English) Vl 06 January 20t2. Poster- (English) V I 06 January 20t2. Tote Bagso Principal lnvestigator- Curriculum Vitae Dated 04 Nov 201 I. l n \ec t i ga lo i5 I ndenak ing_Da led l 4 De ;201J

The fol lowing members of the Shatabdi Hospital Ethics Committee were pfes€nt at the meetingheld on 06 March 2012 in Sharabcli Superspccial iry l lospiral, Nashik at 9 am.

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SUYOJIT CIry CENTRE, OPP MAHAI\4ARG BUS STAND, MUMBAINAKA, NASHIK 422 OOs.PH. 0253 6639001

Name OfTheMember Afliliation

Dr. NeelimaChafekar MD,, DRM

H.O.D. of Medicine, inNDMVPS MedicalCol lege & Nucleaf

Physician in Nuscint ScanCentre, Nashik

Chairperson

Shatabdi Hospital Ethics Gommittee

SahyadriSeva Heallh Care Pvt, Ltd.'s

9ratabdiSUPER SPECIALITY H()SPITTAL

Dr. Mrs. Meenal Mohgaonkar, r,lDChailperson

Dr. Nitin Ghaisas, r,lD

SHEC approves the study protocol and othef study related documents condit ionally in the correclversion number and date. However prior conducting the sludy at Shatabdi Superspecial i tyHospital the SIIEC has ro be notif ied about DCGI approval and CTA for conduct olthis study.

Dr. Nit in Ghaisas who is a member of the Ethics committee has not voted or provided opinionfor the review an approval oflhe above refcrenced study.

This is to confirm thal only members who are independent ofthe lnvestigator and the Sponsor ofthe tr ial have voled/ provided opinion on rhe tr ial.

The Shatabdi Hospital Ethics Committee expects to be inlormed about the progress ofthe study,any SAE occurring in the course ofthe study, protocol deviation and any changes in the protocoland patient information/inlormed consent and asks to be provided a copy ofthe final report.

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SUYOJIT Clry CENTRE, OPP,I\,IAHAMARG BUS STAND. I\,IUMBAI NAKA, NASHIK422 OOs'PH' 0253 6639001

2. Dr. PushkadniDesai F M.D. (Med) Consultant Physician al

Shatabdi Hospital, NashikJoint Member

Secrelary

3. Mr. YatinPatwardhan M B.Con.. F. C.A.

Lay person, Private C.A..Nashik Member

Mr R a," indra Pagar M BSc., LLB Legal Representalive,Advocate. Nashik

Member

5 . Mrs. N4rudula Bele F M. Phann.Basic Medical Scientist.

MVP's College ofPharmacy. Nashik

Member

6. Mr. Ashok Khurade M B , A . L . L . B .Social Scient ist . President

of Suvichar Manch(NGO). Nashik

Member

'7. Mr. ShashankGarud

M B.Com.L.L.B.Legal Representalive,

Advocate. NashikMember

,g'sH,Ht$LO 6 I{AR ZO]Z

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SUYOJIT CIry CENTRE, OPP I\,IAHAMARG BUS STAND, I\,IUMEAI NAXA, NASHIK422 OOs,PH,0253 6639001

Sahyadf Seya Health Care Pvl. Lld.'s

SIJPER SPECIALITY H(}SPILTALShatabdi Hospital Ethics CommitteeDr. Mrs. Meenal Mohgaonkar, [.rDChaiperson

Dr. Nitin Ghaisas, MDMemberSecrclary

This is to inform you that SHEC works as per ICH-GCP, Schedule y and allthe applicable localregulatory requirements.

Please quote the EC reference number i.e. EC/Pharma/2012-02,rf.,1G for further correspondenceabout this study.

Yours sincerely. o.

l\*&^ . . I - ' \ '5rgnature and uate:Dr. Pushkarini DesaiJoint Member SecretaryShatabdi Hospital Ethics committee