t, www.sdmerc-shaishavclinic.com I E-mail: [email protected] SANT DNYANESHWAR MEDICAL EDUCATION RESEARCH CENTRE ETHICS COMMITTEE 695-A, Sadashiv Peth, Laxmi Road, Opp. Vijay Talkies, Pune - 411030. Ph.: 24457234, 24450378, Fax No. (020) 24465419
Date: 06/03/2012
To, Dr. Prakash Vishnu Joshi Sant Dnyaneshwar Medical Education Research Center 695/ A, Sadashiv peth, Opp. Vijay Talkies, Laxmi road Pune.
Reference: "A Multicenter, Open label, Phase IV study to evaluate safety and tolerability of BE's inactivated vero cell derived Japanese Encephalitis vaccine in 2! 18 to s 49 year old healthy adult subjects in a two dose schedule."
Subject: Ethics committee approval for the above referenced clinical trial
Dear Dr. Prakash Vishnu Joshi,
Sant Dnyaneshwar Medical Education Research Center Ethics Committee met, reviewed and discussed your application to conduct the clinical trial entitled, "A Multicenter, Open label, Phase IV study to evaluate safety and tolerability of BE's inactivated vero cell derived Japanese Encephalitis vaccine in 2! 18 to s 49 year old healthy adult subjects in a two dose schedule."
The following documents were reviewed and approved during the meeting-
1. Study Protocol (Protocol No. BECT021/JEV-PIV /CTP-Ol, Version: 1.0 dated 21/10/2011). 2. Case Report Form (Protocol No. BECT021/JEV-PIV /CTP-Ol, CRFVersion: 1.0 dated 21-10-11). 3. Informed Consent Form (Protocol No. BECT021/JEV-PIV /CTP-Ol, ICDVersion: 1.0 dated 21-10-11). 4. Subject Information Sheet (Protocol No. BECT021/JEV-PIV /CTP-Ol, Version: 1.0 dated 21-10-11). 5. Subject Diary Cards (Protocol No. BECT021/JEV-PIV/CTP-01, Version: 1.0 dated 21-10-11). 6. No Objection Certificate (NOC) from DCGI 7. Manufacturing and Marketing license from DCGI 8. Copy of Insurance and Indemnity letter 9. Summary of Product Characteristics
1 .sdmerc-shaishavclinic.com -rnait : [email protected] SANT DNYANESHWAR MEDICAL EDUCATION RESEARCH CENTRE ETHICS COMMITTEE
695~A, Sadashiv Peth, Laxmi Road, Opp. Vijay Talkies, Pune - 411030. Ph.: 24457234, 24450378, Fax No. (020) 24465419
At the EC meeting held on 24th February 2012, your referenced letter and study related documents were examined and discussed. After due consideration Ethics Committee raised some queries which were clarified by the sponsor Biological E. Limited, Hyderabad. IEC has decided to approve conduct of study under your direction at Sant Dnyaneshwar Medical Education Research Center, Pune. This approval is valid until 1 year i.e. 06/03/2013 as per the EC norms.
The following members ofEC were present at meeting held on 24th February 2012 at 03:30 pm at Sant Dnyaneshwar Medical Education Research Center, Conference Hall.
Sr. No. Name and Gender Qualification Affiliation/Designation within EC 1 Dr. Hemant Kulkarni M.D. Chairman Biochemistry 2 Dr. Anil Jaywant M.B.B.S Secretary 3 Dr. R.D.Deolankar Post Doc Medical Scientist Biotechnology, Ph.D. Nutrition 4 Dr. Padmakar Pandit M.D.( Pharm) Medical Scientist 5. Dr. M.Akkalkotkar M.D. (Ayurveda Medical Scientist Pharmacy), T.C.Y FIlM ,Ph.D 6. Dr. Chinmay Saraf M.D.Pathology Medical Scientist 7. Dr. C.K. Deogaonkar M.D (Med) Clinician
8. Adv. Sandhya Gaikwad Master of Social Social Worker work, LLB 9. Dr. Sanjay Potdar M.D. (Ped.) Clinician
The Following EC members were absent at the meeting
Sr. No. Name and Gender Qualification Affiliation/Designation within EC 1. Dr. Mahesh Mokashi M.B.B.S Social Worker 2. Mr. Milind Tamboli B.Com Lay Person
2 .sdmerc-shaishavclinic.com -mail: [email protected] SANT DNYANESHWAR MEDICAL EDUCATION RESEARCH CENTRE ETHICS COMMITTEE
695-A, Sadashiv Peth, Laxmi Road, Opp. Vijay Talkies, Pune - 411030. Ph.: 24457234, 24450378, Fax No. (020) 24465419
We approve the trial to be conducted in its presented form. It is also confirmed that neither you nor any of the study members have participated in voting decision making procedure of the committee.
We confirm that Sant Dnyaneshwar Medical Education Research Center Independent Ethics committee operates as per Schedule- Y and GCPguidelines. The EC expects to be informed about following-
1. Progress of the study and copy of final report 2. Any SAE occurring during the course of the study 3. Any deviation or changes in protocol to eliminate immediate hazards to study subjects. 4. Any changes in study documents.
Yours sincerely,
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