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maanav health foundationINDEPENDENT ETHICS COMMITTEE
maanavhealth foundation
Reg. No. : E/6733NadodaraEst.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 YajnikM.D. (Physician & Cardiologist)
Ph: 2774444. M : 9898299882
MEMBER SECRETARY
Mr. Rakesh Patel(Chemist)
Ph: 2412752 M : 9925522171
Committee Members
Dr. Kamlesh C. PatelM.D. (Pathologist)
Dr. Sandip H. ShahM.D. (Consultant Psychiatrist)
Dr. lIa RawalM.S.W .• Phd
(Prof. Faculty of social work)
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
Safety Reports for ,Ofatumumab (Issued from IB I,
cut-off date 21-Dec-20 11) Ilisted below:
3 INDSR# Issue Date - -A0982579A 9-Jul-12ZOO07193A 2-Jul-12A0891472A 1-Jun-12ZOO04210A 2-Apr-12ZOO06639B 23-Mar-12
Periodic Safety Reports forOfatumumab (Blinded format)for below quarters:
4 • I-Nov-20ll to 31-Jan- - -2012
I• 01-Feb-2012 to 30-Apr-2012
Regulatory Documents
• DCGI Approval Letter~ Protocol
Amendment-Z 02-Jun-20115
~ --Protocol 13-Jul-20 10Amendment-I 13-Jul-20 10
• Import T-License 13-Jul-20 10
• Export DGFT NOC
6Annotated e-Case Record
07-Jul-2010--Form WorkbookSubject Questionnaire Booklets: English, Hindi, Gujarati
7 o Screening26-0ct-2009--o Post-Screening
Patient Emergency Cardso English 17-Mar-2005
8 o Hindi 30-Jan-2007--o Gujarati 02-Feb-2007
Confidential Page 2 of4
Clinical Trial ABPI Compensation Guidelines .
9o Englisho Hindi -- --U Gujarati
10 Bajaj Allianz Insurance (Blanket copy)01-Jan-2012 to--31-Dec-2012
11 Confidentiality Agreement--- 08-Jun-20 12
12 Investigator Undertaking to DCGI--
-- 22-Jun-20 1213 Draft Clinical Trial Agreement (Tripartite) -- --
Brief Resumeo Principal Investigator - Dr. Seema Bhatwadekar -- --
14 o Sub investigator - Dr. Nirajkumar Navinchandra -- --Bhatt
15Written Informed Consent FOlTnfor OMB112517-
03.02.01 1O-Jul-2012English
16Translation of Written Informed Consent Form for
03.02.01 10-Jul-2012OMBl12517 - Hindi
17Back translation of Written Informed Consent Form for
03.02.01 10-Jul-20l2OMBl12517 - Hindi I
Translation of Written Informed Consent Form for 118 03.02.01 10-Jul-20 12 !
OMB 112517 - Gujarati i- ---
19Back translation of Written Informed Consent Form for
03.02.01 10-Jul-2012OMB 112517 - GujaratiTranslation and Back translation certificates for ICFs v. 03.02.01
20 o Hindi -- --o Gujarati -- --
21 Study Procedures Manual 9 08-Nov-2011
The following members of the ethics committee were present at the meeting·Sr. Nature of
Name QualificationNo Representation
Dr.Ninnit YajnikMD.Medicine Clinician1.
Chairperson
2.Mr.Rakesh Patel - Member B.Sc. Lay personSecretary
Member, Basic Medical3. Dr.Kamlesh Patel MD.Pathology
Scientist
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.
Confidential Page 4 of 4