MULJIBHAI PATEL SOCIETY FOR

Transcription

1 MULJIBHAI PATEL SOCIETY FOR ie~i~ Emnil : info~lmpuh.org Visit: wuw.mpuh.org j~i~i Dr. Virendra Desai Road, NADIAO Oujarat- India. Phones : (0268) to Pax No. : (0268) :i Date: 18/01/2011 Ref. No. EC112Sd?D11 To, Dr. Sishir Gang Chairman, Dept.pf N~ry~hrology 01 FEB 2011 Muqibhai Patel Urological Hospital, Or. Virendra Desai Road Nadiad RECEIVED ON Gujarat, India Dear Dr. Sishir Gang, Sub: Conditional approval pending DCGI clearance for study entitled: "A Phase 2, Randomized, Doublaglind, Pla~bcControlled, Parallel Group, Nlulti-Centw Study To Evaluate The Effrcacy And Safety Of OncsDairy Administration Of A Phosphodiesterase 5 inhibitw (PF ) In Adults WIUI Type 1 Dlabaas And Overt Nephmpathy" The Institutional Ethics Committee I Independent Ethics Committee Muljibhai Patel Society for Research in Nephro-Urology Ethics committee (MPSRNUEC) reviewed and discussed your application to conduct the clinical trial A entitled Re: "A Phase 2, Randomized, Double-Blind, PtaeeboControllad, Parallel Group, Multi-Center Study To Evaluate The Efficacy And Safety Of Once-Daily Administration 01 A Phosphodiestease 5 inhibitor (PF4048BT91) In Adults With Type 2 Diabetes And Overt Nephropathy" on 15101/2011. The following documents submitted for the above-mentioned clini~al project were reviewed 1. Protocol version 15 Jul Informed Consent Document Part I version 02 December 2010 in English and translations in Hindi and Gujarati: 3. Informed Consent Document Palt II - Consent For Additional Research: Samples To Be Banked for Erploratoly Research version 02 December 2010 in English and translations in Hindi and Gujarati. 4. Exposure in Utero Partner R~ease of information form customized for india on 31 Jul 2008 and for A study on 03 Dec 2010 in English, Hindi and Gujarati. Investigators Brochure dated June 2010 along with Erratum 1 version July 2010 and Enatum 2 version August Narrative Line Listing dated 02 Dec 2010 for the period: 01 feb 2010 through 20 Nov 2010, 7. Patient Dosing Diary version i, 19 August 2010 in English and translation in Hindi and Gujarati.

2 N1ULJIBHAI PATEL SOCIETY FOR Dr. Virendra Desai Road, NADIAD Gujarat - India. Phone: (0268) ' Fax No,: (0268) ,,, Visit: 8. Study Level Lifestyle Guidelines version 20 October 2010 in English and translations in Hindi and Gujarati. g~ Instructions for Patient Urine Collection at Home version 28 October 2010 in English and translations in Hindi and Gujarati. 10. Case Report Fbrm version 08 September Rationale for Use of Placebo dated 23 July Rationale for inclusion for patients Over 65 years old dated 18 Sep Insurance certificate dated 25 November 2010 for the period 4m Febnrcuy 2010 to 3" February Patient 10 Card for use to be given to the patients 15. Proposed method or patient accrual as mentioned below: Patients visiting our hospitalllnstitute OPD's Referred patients from primary health care centrelprivate practitioners or other institutesl through verbal communication and discussion Patient Database Hospitals 18. Insurance Ceitif~cateiCompensation for serious adverse events occurring during the study participation [as per agreement with sponsor (draftemplate) and informed Consent Document] 17. Principal investigator's current CV. 18. Investigator's Undertaking (As required by Appendix VII as per Schedule Y 20 Jan 2005 amendment) 19. Investigator's agreement with sponsor. 20. Additionally, we note your proposal to enroll a maximum of 101 subjects at this site. 21. Patient. travel expense reimbursement at the ate of Rs. I for patients within the city and Rs. sfor patients outside the city. 22. We will be using the below mentioned labs as the central lab for all protocol specified investigations in the study and local labs at our institute will be used in emergency. Central Labs: Covenca Central Laboratory Services 1 international Business Park #05-12PJB The Synergy Singapore

3 MU LJIBHAI PATEL SOCIETY FOR i~a~i~ii Dr. Virendra Desai Road, NADIAD Gujara(- india. Phone : (0268) to Fax No,: (0268) Visit: www,mpuh.org Covancs Central Laboratory Serrices 8211 SciCor Drive Indianapolis IN USA BASi 1 International Business Park 2701 Kent Ave West Lafayette IN USA Pfizer PDNI M Eastern Point Road Groton CT USA PflzerOlobal R(L~D Heights Technology Centre 23 Kings Highway Groton CT USA Local Lab: Laboratory, Muljibhai Patel Urological Hospital Dr. Virendra Desai Road Nadiad Gulaat, India

4 ~- -~-~---~ -- --~ ~~~~--~ N1U LJIBHAI PAT EL. SOCIETY FOR RESEARCH IN NEPH RO-UROLOGY Dr. Virendra Desai Road, NADIAO - 38T 001. Cujarat - India. Phone : (0258) to Fax No.: ( Visit: www,mpuh.org i~r The following members of the Ethics Committee were present at the meeting held on at a.m. in the Boardroom, Jayarandas Patel Academic Centre. Members of Ethic;ll Committee Sr. No Name of the Member Position in Ethics Designation 8 Affiliation QualifleaUon Gender Committee / Professor of Medicine i Pandya i PramukhswamiMedical 1 Dr.Himanshu Chairman Karemsad 2 [)r.r.b.sabnis Member Chairman, Dept,of M.BB.S., MS, M Urology, Consultant MD M.Ch. 3 Dr.Lalit Panchal Member Consultant Radiologist MD, DMRE H Dept.cf RadiDlogy, NIPUH 4 i Dr,V,Muthu Member Vice Chairman, Dept of MS, M.ch M Urology, Consultant M 5 Dr.Umapati Hegde Member Consultant MD,DNB,FISN M Nephrologist, Dent of MWH Dr. Mrs, Sujataben Social Worker Medical Social Worker, MA, PhD F 7 Mr. N.Bha9karan Legal Expert General Manager- M.Com, MBA, M LL.B 8 i Mr. SunilDesai Layman SocialWorker B.Sc M 9 DI.Bama Ganguly Pharmacologist Additional Professor NID F Pramukhswami Medical Karamsad ~O Dr.ltaritha Medical Pamukhawami Medical Mg DM F Karamsad 11 i Dr.Shashikant Member Secretary/ Consultant Urologist, MS,DNB M Misha Conditional Approval granted, Kindly submit a copy of DCGI approval letter before commencing any study related activity. Muqibhai Patel Society for Research in Ne~hro-Uralogy Ethics committee (PIIPSRNUEC) expects to be informed about the progress of the study, any SAE occurring in the course of the study, any changes in the protocol and patient informationlinformed consent and asks to be provided a copy of the final report.

5 N1U LJIBHAI PA7EL SOCIETY I=OR 8 E S EA R C H 1N N E P H RO- U RO LO GY Dr. Virendra Desai Road, NADIAD a01. Gujarat - India. Phone : (0268) to Fax No.: ( i~y?l~ Visit: It is hereby confirmed that neither you nor any of the study team members have participated in the votingtdecision making procedures of the committee. We hereby confirm that the Muqibhai Patel Society for Research in Nephro-Un~logy Ethics committee (MPSRNUEC) is organized and operates as per GCP and applicable regulations. ~i?t~cu` :3 Or. SHMhikaR(Mishra ii i; Date: Muijibhai Patel Society for Research in Nephro-Urology Ethics Committee