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Institutional Ethics Committee Sri Venkateswara Institute of Medical Sciences, Alipiri Road, Tirupati-S17 507

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Institutional Ethics Committee Sri Venkateswara Institute of Medical Sciences, Alipiri Road, Tirupati-S17 507 _____.H. ___. Institutional Ethics Committee Sri Venkateswara Institute of Medical Sciences, Alipiri Road, Tirupati-S17 507 Roc. No. A&E/08/IECjSVIMS/04 Date: 13.08.2009 To Dr. Rajasekhar Professor & Head Department of Cardiology Sri Venkateswara Institute of Medical Sciences Tirupati - 517 507 Dear Dr. Rajasekhar. The Institutional Ethics Committee reviev... ed and discussed your application to conduct the clinical trial A 7331009 entitled "A PHASE 2A, RA~DOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY INVESTIGATING THE DOSE­ RESPONSE OF PF-00489791 ON ACUTE HE:MODYNA:\-lICS IN SUBJECTS WITH IDIOPATHIC AND FAMILIAL PULMONARY ARTERIAL HYPERTENSION" on 18.06.2009, the project was numbered as lEe-l03. The following documents submitted for the above-mentioned clinical project were reviewed 01. Final Protocol A 7331009 :­ • Protocol version 30 June 2008. • Molecular Profiling Supplement version 30 June 2008. 02. Informed Consent Form:­ • Informed Consent Form Part I version 25 August 2008 in Engl1sh and translations in Telugu Informed Consent Form Part II version 25 AL1gust 2008 in English and translations in Telugu. 03. Investigator's Brochufe ;­ • Investigator's Brochure Version July 2008. • Erratum 1 version July 2008 to the Investigator Brochure July 2008. • Undertaking by the Investigator. 04. Blank Case Report Form - Generation date 2008-07-10 05. Study Related Documents in English:­ • Physician Letter version 3, dated 13 August 2008. • Referral Boucher version 3. dated 13 August 2008. • A7331 009 - Poster & Leaflet version 3, dated 13 August 200B. • A7331 009 - Patient Letter version 3, dated 13 August 2008. • A7331009 - Patient Q & A version 3, dated 13 August 2008. 06. Patient 10 Card for lJse to be given to the patients. 07. Proposed method of patient accrual as mentioned below: (no document) • Patients visiting our hospital! institute OPD's. • Referred patients from primary health care centres I private practit10ners through verbal communication and discussion - (No documents for point No.On 08. We propose to enroll a minimum of 5 patients at this site - (No document). 09. Principal Investigator's current CV. 10. Compensation for serious adverse events occurring during the study participation. (PTO) Pl2 11. Insurance Certificate for Study A7331009 from Pfizer Limited, Clinical Research Department Dt.17.03.2009. 12. Non US clinical Study Agreement with institution between Pfizer limited and Sri Venkateswara Institute of Medical Sciences, Pfizer Protocol # A7331 009. 13. Use of below mentioned laboratories in this study. Central Lab: Quintiles Technologies (India) Private Limited - Laboratory Division, 301-A-2. The leela Business Park, Andheri-Kurfa Road, Andheri (E), Mumbai 400 059. Maharashtra, India. Local Lab: Sri Vertkateswara Institute of Medical SCiences, Department of Cardiology, Tirupati 517 507, Andhra Pradesh. India. The following members of Ethics Committee were present at the meeting held on 18.06.2009 at Committee Hall of SVIMS from 02.30 to 05.00 pm. I Name Qualification Designation I I Affiliations as to the Institutl~ Title ' Yes/No I Dr.G.Subramanyam MBBS, OM Director, SVIMS Establishing & constituting Authority • . Prof.R.Ramamurthi MSc' j Ph.D • Chairperson Rid. V;reChanceltor. SVU I rl i-::­ Dr.M.S.Moorthy MD, DRM (BARC) Member Registrar I/C & Professor & HOD, Secretary Dept. of Nudear Medicine, SVII'1S i Dr.B. Vel19amma MBSS, DM Member i Dean, Professor & HOD, Dept. of • Neurology Dr,A.Mohan MOOS, MD Member, I'1edical I HOD( Dept. of f'.1edictne, SVIMS , Scientist i SmtM.Subhashini B.A., L.LB., Expert Member, Advocate & SVIMS Standing Legal Counsel of SVIMS. .. ~.- ­ Dr.Balachander MBBS, MD, Subject Expert Cardiologist from ]IPMER DM (card.) from outside the Pondicherry 1 institution i We approve the trial to be conducted in presented form SVIMS lEe 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 information I informed consent and asks to be provided a copy of the final report, We hereby confirm that the SVIMS lEe is organized and operates as per GCP and applicable regulations. Signature Date 13.08.2009 Name Dr.M.S.Moorthy Registrar IIC Be. Member Secretary .
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