29/JUN/2011 IEC/06-111016. Mr. Nishith Mehta 7. Mr. Narendra Mehta Dr. Preeti Mehta Deputy Chairman...

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.

ti' '1'

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

Dr. Preeti Mehta

Member SecretaryDeputy Chairman Chairman

Mr. Guarang ShelatMr. Bhupendra Shah

Date: 29/JUN/2011Ref.: IEC/06-11101To,Dr. Bhavik BhavsarLavanya Skin Clinic303, Aishvarya Complex, Above US Pizza,Jawahar Chowk, Maninagar, Ahmedabad-380008

Reference A Randomized, Investigator-Blind, Three-arm, Parallel Assignment, Multi-centre, Comparative Efficacy and Safety Evaluation of Three Tacrolimus0.1% Topical Ointment Formulations.

Subject Ethics Committee approval for the conduct of the referenced study underyour direction at your centre "Lavanya Skin Clinic" in Ahmedabad.

Dear Dr. Bhavik Bhavsar,

The Independent Ethics Committee has reviewed and discussed your application to conduct thereferenced study during the meeting held on 25th June 2011 at 4 pm 'at 57, Brahmin MitraMandai Society, B/W Paldi Bus Stop & Jalaram Mandir, Paldi, Ahmedabad 380 006.

The following documents were reviewed and discussed during the meeting:

Sr.:> ,

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11~'·· .. ,'",,' ::",,:, . Document Version andDate -;

;.Nllmlwrof·'i<"" " . , ·Copi~s.

: ,,:' , .". " , .... ':; " . . . :. ;- "." - :;~. )--,

, .081-11 study Protocol (Control Copy No. 29- Version: 02

101.38) Dated: 16-May-11

2. Protopic - Prescribing Information -- 10

Informed Consent Document in EnglishVersion: 02

103. Dated: 16-May-llInformed Consent Document Translated from Version: 02

104.English to Hindi on OS-Jun-11 Dated: 16-May-llInformed Consent Document Back Translated Version: 02 .

105.from Hindi to English on 09-Jun-ll Dated: 16-May-llInformed Consent Document Translated from Version: 02

106. English to Gujarati on 08-Jun-l1 Dated: 16-May-11 ii- of 4

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

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

Deputy Chairman Chairman Member Secretary

Dr. Preeti Mehta Mr. Bhupendra Shah . Mr. Guarang Shelat

7.Informed Consent Document Back Translated Version: 02from Gujarati to English on 09-Jun-l1 Dated: 16-May-l1

10

8. Patient Diary Card 01 - 04 in English Version: 0110Dated: 18-May-ll

9.Patient Diary Card 01 - 04 Translated from Version: 01

10English to Hindi on 08-Jun-ll Dated: 18-May-11

10.Patient Diary Card 01 - 04 Back Translated Version: 01 10

from Hindi to English on 09-Jun-11 Dated : 18-May~ 11

11. Patient Diary Card 01 - 04 Translated from Version: 01 10English to Gujarati on 08-Jun-ll Dated: 18-May-ll

12.Patient Diary Card 01 - 04 Back Translated Version: 01

10from Gujarati to English on 09-Jun-l1 Dated: 18-May-l1

Patient Instruction Card in EnglishVersion: 02

1013.Dated: 16-May-11

Patient Instruction Card Translated from Version: 021014.

English to Hindi on 08-Jun-l1 Dated: 16-May-l1Patient Instruction Card Back Translated from Version: 02

1015.Hindi to English on 09-Jun-ll Dated: 16-May-l1

Patient Instruction Card Translated from Version: 021016.

English to Gujarati on 08-Jun-ll Dated: 16-May-l1Patient Instruction Card Back Translated from Version: 02

1017.Gujarati to English on 09-Jun-l1 Dated : 16-May~1l

18.Acknowledgement Copy ofDCGI

10--Notification, Dated 02-Jun-ll

19.Copy of Insurance Certificate, Valid up to 30-

--- 10Apr-12

20. Draft copy of Case Report Form ---- 1021. Copy ofInvestigator Undertaking ---- 1022. Copy of Investigator CV with MRC ---- 1023. Copy of Protocol Signature page ---- 1024. Site Detail Form --- 10

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


Mr. Bhupendra Shah Mr. Guarang Shelat


Deputy Chairman Chairman Member Secretary

Dr. Preeti Mehta

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

Member Name Designation Role Gender

Mr. Bhupendra Shah Chairman Social scientist Male

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

Dr. Shashank Desai Member Basic Medical Scientist Male

Mrs. Ushaben Pathak Member Legal Expert Female

Mr. Niranjan Bhagat Member Lay Person from the community Male

Mr. Nishith Mehta Member Social scientist Male

Dr. Himanshu Shah Member Clinician Male

Mr. Deepak Kolsawala Member Social scientist Male

Mr. Narendra Mehta Member Legal Expert Male

It was observed that the main title of study did not specify study indication - i.e., atopicdermatitis and also study population - i.e, adult patients with moderate to severe intensity ofdisease. While considering the wording in the extreme left box of the header, it is clear that thisstudy includes adult patients with moderate to severe atopic dermatitis. Based on aboveinformation, this ethics committee approves the afore mentioned study for evaluating Tacrolimusointment (0.1 %) in adult patients with moderate to severe atopic dermatitis.

We approve the trial to be conducted in its presented form under your direction at your centre"Lavanya Skin Clinic, Ahmedabad".

The Ethics Committee expects to be informed about the progress of the study, any SAEoccurring in the course of the study and Suspected Unexpected Serious Adverse Reaction(SUSAR), any changes in the protocol and patient infonnationlinfonned consent and request youto provide periodic study reports and a copy of final report ofthe study. (It

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



Dr. Preeti Mehta

Member SecretaryDeputy Chairman Chairman

Mr. Guarang ShelatMr. Bhupendra Shah

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 IndianGCP, ICH-GCP and Schedule Y.

Yours sincerely,

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

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29/JUN/2011 IEC/06-111016. Mr. Nishith Mehta 7. Mr. Narendra Mehta Dr. Preeti Mehta Deputy Chairman...

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