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 : mhftrust@rediffmail.com

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)

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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.

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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

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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

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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.

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