biw paldi bus stop jalaram mandir, paldi, ahmedabad 380 006....dr.rupesh mehta principal...

/'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.

Members:I. Dr. Shashank Desai2. Dr. Himanshu Shah3. Dr Bhasker Vyas4. Dr. Paresh Shah5. Mr. Tapesh Maheshwari6. Mrs. Ushaben Pathak7. Mr. Deepak Kolsawala8. Mr. Nishith Mehta

Dr. Preeti Mehta Mr. Niranjan Bhagat Mr. Guarang Shelat

Deputy Chairman Chairman Member Secretary

Date: 22/FEB/2012Ref.: IEC/02-12/01To,Dr.Rupesh MehtaPrincipal Investigator57, Brahmin Mitra Mandai Societ,BIW Paldi Bus Stop & Jalaram Mandir,Paldi, Ahmedabad -380006,India

Study Title: Open-label pharmacokinetic study of iron isomaltoside 1000 (Monofer®) administeredby 500mg IV bolus injection or 1000 mg intravenous infusion to patients with lnftamrnatory BowelDisease.

Protocol Identifier: Pharmacosmos NS Protocol: P-Monofer-PK-IBD-02

Reference: EC Submission letter dated 09/Feb/ 2012 and 14/Feb/ 2012

Subject: Ethics Committee approval for the conduct of the above mentioned study.

Dear Dr. Rupesh Mehta,

Kindly find below the list of documents discussed & approved during the meeting held on 17/FEB/2012 by Independent Ethics Committee. The following documents have been reviewed & approved:

S. No. Documents Version No. Date

1. Protocol (with Sponsor Signature Page & PI Version: 3.0 09 Dec 2011Signature Page)

2. DCGI Submission letter NA 02 June 2010

3. DCGI Approval letter NA 25 Nov 2011

4. DCGI notification of amendment 3 NA 22 Dee 2011

5. Investigator's Brochure with signature Page Version: 5.0 20 Dec 2010

6. Note to file for IB version 5.0 NA 27 Dec 2011

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INDEPENDENT ETHICS COMMITTEETel. : 079-26586152 I 7152Fax: 079-26585741E-mail: [email protected]

57, Brahmin Mitra Mandai Society,BfW Paldi Bus Stop & Jalaram Mandir,

Paldi, Ahmedabad 380 006.

Members:I. Dr. Shashank Desai2. Dr. Himanshu Shah3. Dr Bhasker Vyas4. Dr. Paresh Shah5. Mr. Tapesh Maheshwari6. Mrs. Ushaben Pathak7. Mr. Deepak Kolsawala8. Mr. Nishith Mehta



7. Final CRF with appended pages Version: 1.0 26June2010Version: 1.1 Appended with 05

Jan 2012

8. Patient Information Sheet and Informed Version: 1.0 07 Feb 2012Consent Form (Site Specific) - English

9. Hindi Inform Consent Form(Site Specific)

9.a) Final Hindi translation Version: 1.0 07 Feb 2012

9.b) English to Hindi forward translation Version: 1.0 07 Feb 2012

9.c) Hindi to English backward translation Version: 1.0 07 Feb 2012

10. Gujarati Inform Consent Form(Site Specific)

10.a) Final Gujarati translation Version: 1.0 13Feb2012

10.b) English to Gujarati forward translation Version: 1.0 10 Feb2012

10.c) Gujarati to English backward translation Version: 1.0 11 Feb 2012

11. Investigator Undertaking NA 07 Feb 2012

12. Principal Investigator CV & MRC

13. CTRI Screenshot / Registration Number NA 28 Dec 2011

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INDEPENDENT ETHICS COMMITTEETel. : 079-26586152/7152Fax: 079-26585741E-mail: [email protected]

57, Brahmin Mitra Mandai Society,BIW Paldi Bus Stop & Jalaram Mandir,

Paldi, Ahmedabad 380006.

Members:1 Dr. Shashank Desai2. Dr. Himanshu Shah3. Dr Bhasker Vyas4. Dr. Paresh Shah5 Mr. Tapesh Maheshwari6. Mrs. Ushaben Pathak7. Mr. Deepak Kolsawala8. Mr. Nishith Mehta



Valid up to 1Sl Jul 2010 to so"14. Insurance Certificate Jun 2012

Policy No- OG-11-1113-3306-00000002

15. Translation Certificate ( Forward & Backward Translation)

16. Draft CTA

The following members of the Independent Ethics Committee were present at the meeting held on17/FEB/2012, Mehta Hospital, Paldi, Ahmedabad, India.

Sr. No. Name Role in Ethics Committee Sex1. Mr. Niranjan Bhagat Chairman- Male

Lay person from the community2. Mr. Gaurang Shelat Member Secretary Male

3. Dr. Shashank Desai Clinician Male

4. Dr. Bhasker Vyas Basic medical scientists Male

5. Dr. Himanshu Shah Clinician Male

6. Mrs. Ushaben Pathak Legal expert Female

7. Mr. Deepak Kolsawala Social scientist Male

8. Mr. Tapesh Maheshwari Pharmacologist Male

9. Mr. Nishith Mehta Social scientist Male

We approve the trial to be conducted in its presented form at Mehta Hospital, Paldi, Ahmedabad -380006 India with Dr. Rupesh Mehta as the Principal Investigator.

Institutional Ethics Committee also expects to be informed about:

1. Progress of the study.2. Any SAE occurring in the course of the study.3. Any changes in the protocol & patient informationlinformed consent.4. Copy of the final report.

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INDEPENDENT ETHICS COMMITTEETel. : 079-26586152/7152Fax: 079-26585741E-mail: [email protected]

57, Brahmin Mitra Mandai Society,B/W Paldi Bus Stop & Jalaram Mandir,

Paldi, Ahmedabad 380 006.

J\lcmbers:l. Dr. Shashank Desai2. Dr. Himanshu Shah3. Dr Bhasker Vyas4. Dr. Paresh Shah5. Mr. Tapesh Maheshwari6. Mrs. Ushaben Pathak7. Mr. Deepak Kolsawala8. Mr. Nishith Mehta



This is to confirm that neither you that is Dr. Rupesh Mehta (PI) nor any study staff participating in

this study were involved in the voting procedures and decision making for this study.

Institutional Ethics Committee has working procedures in compliance with ICMR Guidelines, ICH-

GCP Guidelines, Schedule Y and applicable local laws.

Yours Sincerely,

\I~ ~~;1;L~~/.~r~iranj®>Bhagat

ChairmanIndependent Ethics Committee57, Brahmin Mitra Mandai Society,B/W Paldi Bus Stop & Jalaram Mandir,Paldi, Ahmedabad -380006,India

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