B/WPaldi Bus Stop Jalaram Mandir, Paldi, Ahmedabad 380 006. · IND£PENDENT ETHICS COMMITTEE Tel. : 079-26586152/7152 Fax: 079-26585741 E-mail: [email protected] 57, Brahmin

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.

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

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

Deputy Chairman Chairman . Member Secretary

Date: 19/03/2012Ref.: IEC/03-12/05To,Dr. G M VinodVallabh Park Hospital,N2, Vallabh Park Soc.Opp. Hariomnagar, Ellora Park,Vadodara-390023, Gujarat, India

Protocol No: 311-09

Reference: A Randomized, Double-Blind, Placebo-controlled, Three-arm, Parallel Assignment, Multi-centre, Therapeutic Equivalence Study of Two Tacrolimus 0.1% Topical Ointment Formulations in AdultPatients with Moderate to Severe Atopic Dermatitis.

Subject: Ethics Committee approval for the conduct of the referenced study under your direction at yourclinic "Vallabh Park Hospital" in Vadodara".

Dear Dr. G M Vinod

The Independent Ethics Committee has reviewed and discussed your application to conduct thereferenced study during the meeting held on l Oth March 2012 at 4 pm at 57, Brahmin Mitra MandaiSociety, B/W Paldi Bus Stop & lalaram Mandir, Paldi, Ahmedabad 380 006.

The following documents were reviewed and discussed during the meeting'Sr.No. Document Version and Date

1. Study Protocol (Controlled copy no. 051 to 061) Version no. 02, Dated30th Jan 2012

2. Summary of Product Characteristics: Protopic 0.1 Dated 26-Nov-2006% ointment

3. Patient Information Sheet and Informed Consent Version no. 02, DatedForm in English 06th Feb 2012Patient Information Sheet and Informed Consent Version no. 01, Dated

4. Form in Gujarati Translated from English on 18 18th Feb 2012Feb 2012Patient Information Sheet and Informed Consent Version no. 01, Dated

5. Form in Hindi Translated from English on 18 Feb is" Feb 20122012

Page 1 of3

."" ....-----~~~~~

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

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


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


Deputy Chairman Chairman Member Secretary

Patient Information Sheet and Informed Consent Dated 21 Feb 2012","6. Form Back Translated from Gujarati to English

on 21 Feb 2012Patient Information Sheet and Informed Consent Dated 25th Feb 2012

7. Form Back Translated from Hindi to English on25 Feb 2012

8. Translations and Back Translations Certificates --------

9. Draft E-CRF --10. Patient Diary Cards in English, Gujarati & Hindi Final version 01

dated 07th Feb 2012

11. Patient Diary Cards Back translation of Gujarati Version 01 dated 07th

& Hindi Feb 2012

12.PDC Translations and Back Translations Version 01 dated oillCertificates Feb 2012

13. Investigator's Undertaking Dated: 241n Feb 2012

14. CV & Medical Registration Certificate ofPrincipai Dated: 19th Noy 2011Investi gator

15. Insurance OG-12-2202-3306-00000017 Date: 22na Feb 2012

Patient Instruction Card EnglishVersion: 0)

16.Dated: 3-feb 12

17. Copy ofDCGI acknowledgment of I-License Dated: 30 NoY 2011application

The following members of the ethics committee were present at the meeting:

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

Lay person from the community2. Mr. Gaurang She1at Member Secretary Male,., Dr. Shashank Desai Clinician MaleJ.4. Dr. Bhasker Vyas Basic medical scientists Male5. Dr. Himanshu Shah Clinician Male6. Mrs. Ushaben Pathak Legal expert Female7. Mr. Deepak Kolsawala Social scientist Male8. Mr. Nishith Mehta Social scientist Male

We approve the trial to be conducted in its presented form under your direction at "Vallabh Park Hospital,Vadodara".

Page 2 of3


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


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



Apart from above document we have received following documents which were notify to us aftermeeting..."

s-..No. Document Version and Date

. ....

IPatient Instruction Card Gujarati Translated from Version: 01English on 12 March 2012 Dated: 3-Feb 12

2 Patient Instruction Card Hindi Translated from Version: 01English on 12 March 20] 2 Dated: 3-Feb 12

3 Patient Instruction Card Back Translated from Dated 12- Mar- 12Gujarati to English on 12 March 2012

4 Patient Instruction Card Back Translated from Dated 12 -Mar -12Gujarati to English on 12 March 2012

5Translation and Back Translation certificates ofGujarati and Hindi Patient Instruction card ---

Clarification letter for correction in version and6 date of Protocol in certificates by Kesen Dated 13-Mar-2012

(Translating agency)

The Ethics Committee expects to be informed about the progress of the study, any SAE occurring in thecourse of the study and Suspected Unexpected Serious Adverse Reaction (SUSAR), any changes in theprotocol and patient information/informed consent and request you to provide periodic study reports and acopy of final report of the study.

It is to be noted that neither you nor any of your proposed study team members have participated invoting/decision-making procedures of the Ethics Committee.

Kindly note that the Independent Ethics Committee is constituted in accordance with Indian GCP, ICH-GCP and Schedule Y.

Yours truly,

yL(~,~VMr. Niranjan BhagatChairmanIndependent Ethics Committee57, Brahmin Mitra Mandai Society,B/W Paldi Bus Stop & Jalaram Mandir,Paldi, Ahmedabad -380006,

Date:_~D\~

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Page 3 of3


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


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



Apart from above document we have received following documents which were notify to us aftermeeting..."

s-..No. Document Version and Date

. ....

IPatient Instruction Card Gujarati Translated from Version: 01English on 12 March 2012 Dated: 3-Feb 12

2 Patient Instruction Card Hindi Translated from Version: 01English on 12 March 20] 2 Dated: 3-Feb 12

3 Patient Instruction Card Back Translated from Dated 12- Mar- 12Gujarati to English on 12 March 2012

4 Patient Instruction Card Back Translated from Dated 12 -Mar -12Gujarati to English on 12 March 2012

5Translation and Back Translation certificates ofGujarati and Hindi Patient Instruction card ---

Clarification letter for correction in version and6 date of Protocol in certificates by Kesen Dated 13-Mar-2012

(Translating agency)

The Ethics Committee expects to be informed about the progress of the study, any SAE occurring in thecourse of the study and Suspected Unexpected Serious Adverse Reaction (SUSAR), any changes in theprotocol and patient information/informed consent and request you to provide periodic study reports and acopy of final report of the study.

It is to be noted that neither you nor any of your proposed study team members have participated invoting/decision-making procedures of the Ethics Committee.

Kindly note that the Independent Ethics Committee is constituted in accordance with Indian GCP, ICH-GCP and Schedule Y.

Yours truly,

yL(~,~VMr. Niranjan BhagatChairmanIndependent Ethics Committee57, Brahmin Mitra Mandai Society,B/W Paldi Bus Stop & Jalaram Mandir,Paldi, Ahmedabad -380006,

Date:_~D\~

~:>u'·;:r~-~--/..:!}:,~~1~\~r~:):r.:~i:-;.;'" ./.~;;'t.:·-(~~~/~.'.~~~::(':::.~;.fJt~trtTEf

Page 3 of3

Documents

B/WPaldi Bus Stop Jalaram Mandir, Paldi, Ahmedabad 380 006. · IND£PENDENT ETHICS COMMITTEE Tel. : 079-26586152/7152 Fax: 079-26585741 E-mail: [email protected] 57, Brahmin