maanav health foundation INDEPENDENT ETHICS COMMITTEE maanav health foundation Reg. No. : E/6733Nadodara Est. 01. : 19th Dee 2005 A-1. Anupam Nagar. B/h. Rajvee Tower. Near Tube Company. a.p. Rd .. Vadodara - 390020. INDIA. Tel: +91 265-2340258 Email : [email protected]CHAIRMAN Dr. Nirmit Yajnik M.D. (Physician & Cardiologist) Ph: 2774444. M : 9898299882 MEMBER SECRETARY Mr. Rakesh Patel (Chemist) Ph: 2412752 M : 9925522171 Committee Members Dr. Kamlesh C. Patel M.D. (Pathologist) Dr. Sandip H. Shah M.D. (Consultant Psychiatrist) Dr. lIa Rawal M.S.W .• Phd (Prof. Faculty of social work) Dr. Leena Mehta M.S.w., Phd. (Prof. of social work). Ll.B. Mr. Hardik A. Shah Bcom., L.L.B. Dr. Hetal Thakkar Phd. (Lecturer. Pharmacy Dept.) Dr. Lakhan Kataria M. D, (Consultant Psychiatri5t) Mrs. Dipti Joshi MA, DCCP (Lecturer, SBKS Medical College) Confidential N tt f\ ~C\0 UII~\ '8S Dr.Seema Bhatwadekar Consultant Oncologist Principal Investigator Sterling Hospitals, Opp.Inox, Race Course Circle (West), Vadodara-390007, Gujarat. Date: 20 th Sept.20l2 Dear Dr. Seema, The Maanav Health Foundation Independent Ethics Committee reviewed and discussed your application on n" Sept.20l2 at 4.00 pm at A-I Anupam Nagar, BIh Rajvee Tower, near Tube Company, old padara road, Vadodara-390020, Gujarat, India to conduct the clinical trial entitled: Ref. OMB112517 Titled PROLONG Phase III Trial in Relapsed CLL (Chronic Lymphocytic Leukemia) of a MonocLonal Antibody Ofatumumab maintenance therapy to delay progression vs observation. Page 1 014
4
Embed
maanav - ctri.nic.in...Brief Resume o Principal Investigator - Dr. Seema Bhatwadekar----14 o Sub investigator - Dr. Nirajkumar Navinchandra----Bhatt 15 Written Informed Consent FOlTnfor
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
maanav health foundationINDEPENDENT ETHICS COMMITTEE
Dr. Leena MehtaM.S.w., Phd. (Prof. of social work).Ll.B.
Mr. Hardik A. ShahBcom., L.L.B.
Dr. Hetal ThakkarPhd. (Lecturer. Pharmacy Dept.)
Dr. Lakhan KatariaM.D, (Consultant Psychiatri5t)
Mrs. Dipti JoshiMA, DCCP
(Lecturer, SBKS Medical College)
Confidential
N tt f \~C \0 UII~\ '8S
Dr.Seema BhatwadekarConsultant OncologistPrincipal InvestigatorSterling Hospitals,Opp.Inox,Race Course Circle (West),Vadodara-390007,Gujarat.
Date: 20th Sept.20l2
Dear Dr. Seema,
The Maanav Health Foundation Independent EthicsCommittee reviewed and discussed your application onn" Sept.20l2 at 4.00 pm at A-I Anupam Nagar, BIhRajvee Tower, near Tube Company, old padara road,Vadodara-390020, Gujarat, India to conduct the clinicaltrial entitled:
Ref. OMB112517 Titled PROLONG Phase III Trialin Relapsed CLL (Chronic Lymphocytic Leukemia)of a MonocLonal Antibody Ofatumumabmaintenance therapy to delay progression vsobservation.
Page 1 014
The following documents were reviewed:
Sr. No. Title Version No. Issue I Effective Date
1Protocol no. AmendmentUM2008/00446/03 No.2
21-May-2010
2Investigator's Brochure for
5 07-Mar-2012GSK1841 157 (Ofatumumab)Investigational New Drug
4. Mr. Hardik Shah B.Com, LL.B Member, Legal Expert
5. Dr .LakhanKataria M.D. Psychiatry Member, Physician
6. Mrs. Dipti Joshi MA,DCCP Member, Social
Confidential Page 3 of 4
Scientist .Dr.Ila Rawal Member, Social
7. PhD,M.S.WScientist
Dr.Hetal ThakkarMember, Basic Medical
8. PhDScientist
9. Dr.Sandip Shah M.D. Psychiatry Member, Physician
We approve the trial to be conducted in its presented form.
The Maanav Health Foundation Independent Ethics Committee expects to be informedabout the progress of the study, any SAE occurring in the course of the study, any changes inthe protocol and patient information/informed consent and asks to be provided a copy of thefinal report.
Yours truly,
Mr.Rakesh PatelMember SecretaryMaanav Health FoundationIndependent Ethics CommitteeA-I, Anupam Nagar,BIh, Rajvee Towers,Near Tube Company, O.P. Road,Vadodara- 390 020, Gujarat, India.
Date::::{J st'et-41 <
INDEPENDENT ETHICS COMMI7TEEMAANAV HEALTH FOUNDATIONReg. Office: A·1, Anupam Nagar Soc.,S/h. Rajvee Towers, Nr. Tube Company,O. P. Road, Vadodara·390020.