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JehangirClinical

DevelopmentCentreMEDICAL

RESEARCHr----------------------------------------------------INSTITUTE CLINICAL PRECISION

Date: 26 Apr 2011To,Dr. Vijay TuljapurkarJCDC Pvt.LtdShri Siddhivinayak Ganapati Cancer HospitalMiraj

Protocol No: CCCWFU99107

Protocol Title: A pilot study to evaluate safety and efficacy of HLA-mismatched granulocytetransfusions

in the treatment of patients with solid malignant tumors who are resistant to standardCancer therapy or for whom no standard cancer therapy exists.

SUB: Approval of study documents.

Dear Dr. Tuljapurkar

At the Ethics Committee meeting held on 16 Apr 2011, the documents mentioned below wereexamined and discussed. After thorough consideration, the Committee has decided to approve thefollowing study related documents

1. Protocol with amendment Version 2.0 I 19th July 2010

2. Informed Consent Forms- English - For Donors Version 2.0 I is" July 2010

3. Informed Consent Forms- English - For Version 2.0 I 19th July 2010Patients4. Informed Consent Forms- Marathi - For Donors Version 2.0 I 19th July 2010

5. Informed Consent Forms- Marathi- For Patients Version 2.0 I 19th July 2010

6. Informed Consent Forms- Hindi - For Donors Version 2.0 I 19th July 2010

7. Informed Consent Forms- Hindi- For Patients Version 2.0 I 19th July 2010

The members who attended the meeting held on 16 Apr 2011, at Conference Hall, JCDC between11:00 to 01 :00 pm where your proposal was discussed are as follows:

Hirabai Cowasji Jehangir Medical Research Institute AndJehaugir Clinical Development Centre Ethics Committee

Jehangir Hospital Premises. 32. Sasseen Road. Pune 41100!Ph. 91-20-2605931& Fax +91-20-:?6059319

~~1' Jehangir

~.,)~ Clinical

DevelopmentCentre

PRIMARY AFFILIATION WITHSCIENTIFIC OR INSTITUTION (S)

HIGHEST DEGREES NONSCIENTIFIC (YES/NO; IF YES,MEMBER NAME EARNED SEX SPECIALTY WHICH ONE(S))

M.B.B.S/D.N ClinicalDr. Pratibha Navak Pharmacologist F Scientific No

ConsultantDr. Mrs. Uma P. Divate Phvsician(M.D) F Scientific Yes

Business manMr. Framroze Garda B. Com, M.B.A M Non- Scientific Yes

Mr. C.Y. Joshi B.Com, B.A M Non- Scientific NoNutritionist,M.Sc -Statistics,

Dr. Mrs.Shashi Chiplonkar Phd- Statistics F Scientific Yes

Social Worker,Mrs. Vrinda Pusalkar B.A, M.S.w F Non- Scientific Yes

Mrs. Stella Mendes M.A, L.L.B F Non- Scientific No

M.B.B.S, MHM,Dr. Ujjwal Rao M.Phil, DMLE(PhD) M Scientific Yes

MEDICALRESEARCHr----------------------------------------------------INSTITUTE CLINICAL PRECISION

We approve the tnal to be conducted In Its presented formHirabai Cowasji Jehangir Medical Research Institute and Jehangir Clinical Development CentreEthics Committee expects to be informed about the progress of the study, any SAE occurring in thecourse of the study, any changes in the protocol and patient information/informed consent and asksto be provided a copy of the final report.We confirm that Dr Mrs. U. P. Divate did not vote on the proposal for this study.We hereby confirm that Hirabai Cowasji Jehangir Medical Research Institute And Jehangir ClinicalDevelopment Centre Ethics Committee is organized and operates as per GCP and applicableregulations.

Yours Sincerely,

SignatureName : Dr. Mrs. U.P DivateMember SecretaryHirabai Cowasji Jehangir Medical Research InstituteAnd Jehangir Clinical Development Centre Ethics Committee

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