independent ethics committee - clinical trials registry · dear dr. maksud, the ethics committee...

Tel. : 079-26586152/ 7152Fax: 079-26585741E-mail: [email protected]

INDEPENDENT ETHICS COMMITTEE57, Brahmin Mitra MandaI Society,

BIW Paldi Bus Stop & Jalaram Mandir,Paldi, Ahmedabad 380 006.

Deputy Chairman Chairman

Mr. Guarang Shelat

Members:1. Dr. Shashank Desai2. Mrs. Ushaben Pathak3. Dr. Himanshu Shah4. Mr. iranjan Bhagat5. Mr. Deepak Kolsawala6. Mr. Nishith Mehta7. Mr. Narendra Mehta

Dr. Preeti Mehta

Member Secretary

Mr. Bhupendra Shah

Date: 10fMAY/2011Ref.: IEC/05-11103TO,Dr. Tanveer M. Maksud (MD, ECMO)Principal InvestigatorBharat Cancer Hospital & Research Institute(Managed By Bhartimaiya Memorial Foundation)Manavdaya Trust Sankul, Opp. H.P. Petrol Pump,Surat- Bardoli Road, Saroli, Surat, Gujarat-395010.

Ref: Study: 018-11

Sub: Ethics committee approval for 018-11 study

Dear Dr. Maksud,

The ethics committee has reviewed and discussed your application to conduct clinicaltrial entitled "A multicentre, randomized, double blind, two-period, two-treatment, two-way crossover, bioequivalence study comparing Capecitabine Tablets USP 500 mg(Manufactured by: Intas Pharmaceuticals limited, India) to the reference listed drugXeloda® (Capecitabine) Tablets 500 mg (Distributed by: Hoffmann-La Roche Limited.,Mississauga ON L5N 6L7, Canada) in Metastatic BreastCancer or Colorectal Cancerpatients under fed condition."

The following documents were reviewed and approved by EC members in the meetingwhich was held on 071MA Y/2011, 04:00 pm at Mehta Hospital, Ahmedabad-380006. ECdoes not have any objection to conduct this study at Bharat Cancer Hospital, Surat.

01

Document (along with controlled copy no.,if applicable)

Version 02, Dated 16-April-ll 10

Sr.No.

Version No. & Date No. ofCopies

.Study Protocol (Control Copy No. 042 to051)

02 Erratum of Protocol Version 02 (List ofchanges)

Dated 26-April-ll 10

03Patient Information Sheet and InformedConsent Form in English

Version 01, Dated 26-April-l1 10

04Patient Information Sheet and InformedConsent Form in Gujarati translated on 29-April-l l


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/, Tel.: 079-26586152/7152

Fax: 079-26585741E-mail: [email protected]

INDEPENDENT ETHICS COMMITTEE. 57, Brahmin Mitra Mandai Society,

BIW Paldi Bus Stop & Jalaram Mandir,Paldi, Ahmedabad 380 006..

Members:I. Dr. Shashank Desai2. Mrs. Ushaben Pathak3. Dr. Himanshu Shah4. Mr. Niranjan Bhagat5. Mr. Deepak Kolsawala6. Mr. Nishith Mehta7. Mr. Narendra Mehta

Dr. Preeti Mehta

Deputy Chairman Member SecretaryChairman

Mr. Bhupendra Shah Mr. Guarang Shelat

Patient Information Sheet and Informed05 Consent Form back translated in Gujarati to Version 01, Dated 26-April-l1

English on 04-May-llTranslation certificate for English to

06 Gujarati and Back Translation certificate --for Gujarati to EnglishPatient Information Sheet and Informed

07 Consent Form in Hindi translated on OJ':May-IIPatient Information Sheet and Informed

08 Consent Form back translated in Hindi toEnglish on OS-May-llTranslation certificate for English to Hindi

09 and Back Translation certificate for Hindito English

10 CRF

11 Product Monograph- "XELODA"

12 Investigator Undertaking

13 CV of Investigator

14 DCGI Application Acknowledgement Letter

15 Food Menu

16 Insurance certificate

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10

10


Version 01, Dated 26-April-l'1 10

-- 10

Draft :-Version 00, 10Dated 26-April-llDated 30-Nov-2009 10

-- 10

-- 10

Dated 23-April-2011 10

-- 10OG ~11-2202-3396-00000001; 10Dated 06 April 2011

The following members of the ethics committee were present at the meeting held on071MA Y/2011, 04:00 pm at Mehta Hospital, Ahmedabad-380006.

~';'ber Name ----·--------rD~-;ig;.ati~~-------- I Role ---------- TG~nd-~~--1i Mr. Bhupendra Shah --- i -Chai~a~------------lSocial scientisi------- lMa-l~-----I

!Dr. Preeti Mclrt~=~~=~=~J~~~R~!r~~~~~!~~LBasic Medicaf~cie~!~~! __~=~J F~~~le _--I~

.,' Tel.: 079-26586152/7152Fax: 079-26585741E-mail: [email protected]

INDEPENDENT ETHICS COMMITTEE-57, Brahmin Mitra Mandai Society,

B/W Paldi Bus Stop & JalaramMandir,Paldi, Ahmedabad 3~0 006,

Members:I, Dr, Shashank Desai2, Mrs. Ushaben Pathak3, Dr, Himanshu Shah4, ML Niranjan Bhagat5, Mr. Deepak Koisawaia6, Mr. ishith Mehta7, Mr. Narendra Mehta

Deputy Chairman

Dr. Preeti Mehta

Chairman Member Secretary'({


Mr. Gaurang Shelat Member Secretary Lay Person from the community,Accountant

Male

Dr. Shashank DesaiMrs. Ushaben Pathak

MemberMember

Basic Medical Scientist Male

Mr. Niranjan Bhagat MemberLegal Expert Female

Mr. Nishith Mehta MemberLay Person from the community Male

Dr. Himanshu Shah MemberSocial scientist Male

Mr. Deepak Kolsawala MemberClinician Male

Mr. Narendra Mehta MemberSocial scientist MaleLegal Expert Male

"We approve the trial to be conducted in its presented form subject to theDCGI approval of the above mentioned study and further notification ofDCGI approval to us."

This is to confirm that neither you nor any study team member were present/participatedduring decision making process for approval of the study proposal.

The EC expects to be informed about the progress of the study, any SAEs occurring inthe course of the study, and any changes in the protocol and patient information/informedconsent and asks to be provided a copy of the final report.

The EC operates according to ICH-GCP, current Schedule Y and applicable laws andregulations.

Yours sincerely,

~--Mr. Bhupendra ShahChairmanIndependent Ethics committee,57, Brahmin Mitra Mandal Society,B/W Paldi Bus-stop & Jalaram Mandir, Paldi,Ahemdabad-380 006

CH.~R~.ANINDEPENDENT ETHICS COMf:.rrrrEE

AHMED,{\BAD.

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Date: ----~~~~------

.,' Tel.: 079-26586152/7152Fax: 079-26585741E-mail: [email protected]

INDEPENDENT ETHICS COMMITTEE-57, Brahmin Mitra Mandai Society,

B/W Paldi Bus Stop & JalaramMandir,Paldi, Ahmedabad 3~0 006,

Members:I, Dr, Shashank Desai2, Mrs. Ushaben Pathak3, Dr, Himanshu Shah4, ML Niranjan Bhagat5, Mr. Deepak Koisawaia6, Mr. ishith Mehta7, Mr. Narendra Mehta

Deputy Chairman

Dr. Preeti Mehta

Chairman Member Secretary'({


Mr. Gaurang Shelat Member Secretary Lay Person from the community,Accountant

Male

Dr. Shashank DesaiMrs. Ushaben Pathak

MemberMember

Basic Medical Scientist Male

Mr. Niranjan Bhagat MemberLegal Expert Female

Mr. Nishith Mehta MemberLay Person from the community Male

Dr. Himanshu Shah MemberSocial scientist Male

Mr. Deepak Kolsawala MemberClinician Male

Mr. Narendra Mehta MemberSocial scientist MaleLegal Expert Male

"We approve the trial to be conducted in its presented form subject to theDCGI approval of the above mentioned study and further notification ofDCGI approval to us."

This is to confirm that neither you nor any study team member were present/participatedduring decision making process for approval of the study proposal.

The EC expects to be informed about the progress of the study, any SAEs occurring inthe course of the study, and any changes in the protocol and patient information/informedconsent and asks to be provided a copy of the final report.

The EC operates according to ICH-GCP, current Schedule Y and applicable laws andregulations.

Yours sincerely,

~--Mr. Bhupendra ShahChairmanIndependent Ethics committee,57, Brahmin Mitra Mandal Society,B/W Paldi Bus-stop & Jalaram Mandir, Paldi,Ahemdabad-380 006

CH.~R~.ANINDEPENDENT ETHICS COMf:.rrrrEE

AHMED,{\BAD.

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Date: ----~~~~------

independent ethics committee - clinical trials registry · dear dr. maksud, the ethics committee...

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