Upload
others
View
3
Download
0
Embed Size (px)
Citation preview
.}
JehangirClinical
DevelopmentCentreMEDICALRESEARCHr----------------------------------------------------
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 20103. 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
._--'.
\ . \ "