dr. d. v. doifode · dear dr. sunil gupta, your letter dated 09 dec 2011 with regards to the study...

Chairman: Dr. D. V. Doifode M.D. (Internal Medicine) 9970151696

Secretary : Dr. Sunil Gupta M.D., FIAMS, FIACM, FICP. Diabetologist 9823152lll

Members: Dr. Indu Arneja M.D. (Pathology)

Dr. Ashok Tank M. D. (Forensic Medicine)

Dr. Manohar Wankhede M.B.B.S.

Mr. Umesh Sharma B. Com.

Mr. Jitendra Kurani B. Sc., LLB. (Advocate)

Mr. Subhash Jobanputra B.Sc.

42, Lendra Park, Ramdaspeth, Nagpur- 440 010, M.S., India Phone: +91 712-2428111,2428222,2428333, Fax: +91 - 712 - 2428555

E-mail : [email protected] [email protected]

Date: 21 Dec 2011

To, Dr. Sunil Gupta Diabetes Care n' Research Centre Pvt. Ltd., 42, Lendra Park, Ramdaspeth, Nagpur- 440010, Maharashtra, India

Reference:Study Code: EFC11319: A randomized, double-blind, placebocontrolled, parallel-group, multicenter study to evaluate cardiovascular outcomes during treatment with lixisenatide in type 2 diabetic patients after an Acute Coronary Syndrome

Subject: Ethics Committee approval for study documents for the above referenced study to Ethics Committee.

Dear Dr. Sunil Gupta,

Your letter dated 09 Dec 2011 with regards to the study documents for the referenced study at Diabetes Care n' Research Centre Pvt. Ltd. At the Ethics Committee of Diabetes Care n' Research Centre meeting held on 15 Dec 2011 at 17:00 at Diabetes Care n' Research Centre Pvt. Ltd. 42, Lendra Park, Ramdaspeth, Nagpur- 440010, Maharashtra, India.

Sr. Documents Version no. & date No. 1 Amended clinical trial Version date 27 Jul 2011

protocol3 2 Protocol amendment no.3 Version no.1 dated 27 Jul 2011 3 Amended clinical trial Version date 6 Dec 2010

protocol2 4 Protocol amendment no.2 Version no.1 dated 2 Dec 2010 5 Investigator Brochure Edition no. 8 dated 1 Apr 2011 6 Cumulative listing for From 31 Jan 2011 to 31 Oc;t 2011

Lixisenatide 7 CIOMS for Lixisenatide From 31 Jan 2011 to 18 Nov 2011 8 AVE001 O/EFC11319-Mock Final version 5.0 dated 31 Aug 2011

e-CRF 9 Informed consent form Version no. 2.0.1 dated 17 Feb 201-1 10 Informed consent form-Hindi Version no. 2.0.1 dated 17 Feb 2011 ,

translation date 19 Feb 2011 .

11 Informed consent form- Version no. 2.0.1 dated 17 Feb 2011 , Marathi translation date 18 Feb 201 1

12 Pharmacogenetic analysis Version no. 1 dated 18 Jan 2011 informed consent form

13 Pharmacogenetic analysis Version no. 1 dated 18 Jan 2011 , informed consent form-Hindi translation dated 18 Feb 2011

14 Pharmacogenetic analysis Version no. 1 dated 18 Jan 2011,

Mrs. Manisha R. Andulkar M.A., B.F.A.

informed consent form-Hindi translation dated 18 Feb 2011

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Chairman : Dr. D. V. Doifode M.D. (Internal Medicine) 9970151696

Secretary : Dr. Sunil Gupta M.D., FIAMS, FIACM, FICP. Diabetologist 9823152111

Members: Dr. Indu Arneja M.D. (Pathology)

Dr. Ashok Tank M.D. (Forensic Medicine)




Mr. Subhash Jobaiiputra B.Sc.


42, Lendra Park, Ramdaspeth, Nagpur- 440 010, M.S., India Phone: +91 712-2428111,2428222,2428333, Fax: +91 -712-2428555


15 Informed consentform Version no. 3 dated 6 sep 2011 16 Informed consent form-Hindi Version no. 3 dated 6 sep 2011,

translation dated 17 s~ 2011 17 Informed consent form- Version no. 3 dated 6 sep 2011 ,

Marathi translation dated 17 S~p 2011 18 Patient diary India version no.1,dated 28 Jun 2010 19 Patient diary-Hindi India version no.1,translation dated 09 Jul

2010 20 Patient diary-Marathi India version no.1,translation dated 09 Jul

2010 21 Patient card India version no. 1, 19 MCIY_ 201 0 22 Patient card-Hindi India version no.1,19 May 2010,

translation dated 09 Jun 2010 23 Patient card-Marathi India version no.1,19 May 2010,

translation dated 09 Jun 201 0 24 Opticlik Manual Version no.1 dared 6 Jul 2010 25 Opticlik Manual-Hindi Version no.1 dared 6 Jul 2010,translation

dated 17 A1!9_ 20 1 0 26 Opticlik Manuai-Marathi Version no.1 dared 6 Jul 201 O,translation

dated 17 AL!9_ 201 0 27 Insurance certificate Till 30 AQT 2012 28 DCGI approval letter

The above mention documents were examined, reviewed and discussed. The members who attended the meeting at which your study document were discussed are: ·

Affiliation Sr. Name of the Role in the Qualification [Designation/ Title, Name and no. member EC Address (City, State) of Affiliated

Institute]

Chairman Ethics Committee of Diabetes

Dr. D.V. M.D.(Internal Care n' Research Centre 1.

Doifode Chairperson Medicine) 42, LendFa park, Ramdaspeth

Nagpur-440010 Maharashtra, India

Secretary M.D.,FIAMS, Ethics Committee of Diabetes FIACM,FICP, Care n' Research Centre

2. Dr. Sunil

Secretary Diabetologist 42, Lendra park, Ramdaspeth Gupta Nagpur-440010

Maharashtra, India

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Chairman: Dr. D. V. Doifode M.D. (Internal Medicine) 9970151696 -

Secretary : Dr. Sunil Gupta M.D., FIAMS, FIACM, FICP. Diabetologist 9823152111

Members: Dr. lndu Arneja M.D. (Pathology)





Mr. Sub hash Jobanputra B.Sc.

42, Lendra Park, Ramdaspeth, Nagpur- 440 010, M.S., India Phone: +91 712-2428111,2428222,2428333, Fax: +91 -712-2428555

E-mail: [email protected] [email protected]

Clinician M.D. Ethics Committee of Diabetes

3. Dr.lndu Member

(Pathology) Care n' Research Centre Arneja 42, Lendra park, Ramdaspeth

Nagpur-440010 Maharashtra, India

Scientist

Dr. Manohar Basic M.B.B.S

Ethics Committee of Diabetes

4. Medical Care n' Research Centre

Wankhede Scientist 42, Lendra park, Ramdaspeth Nagpur-440010 Maharashtra, India

Basic Clinician

M.D. Forensic Ethics Committee of Diabetes

Member Medicine Care n' Research Centre 42, Lendra park, Ramdaspeth

5. Dr. Ashok Nag pur -440010

Tank Maharashtra, India

Legal Expert

Adv. Ethics Committee of Diabetes

6. Jitendra Member B.Sc. , L.L.B Care n' Research Centre

Kurani 42, Lendra park, Ramdaspeth Nagpur-440010 Maharashtra, India Social Worker/ Theologist

Mr. Umesh Ethics Committee of Diabetes

7. Sharma Member B.Com Care n' Research Centre

42, Lendra park, Ramdaspeth Nagpur-440010 Maharashtra, India

Lay person/Non scientific/ Non Clinician/ General Public

8. Mrs. Member

M.A., B.F.A Ethics Committee of Diabetes

Manisha Care n' Research Centre

Andulkar 42, Lendra park, Ramdaspeth Nagpur-440010 Maharashtra, India

Businessman

Mr. B.Sc Ethics Committee of Diabetes

9. Shubhash Member Care n' Research Centre

Jobanputra 42, Lendra park, Ramdaspeth Nagpur -44001 0

. - Maharashtra, India .

We approve the trial related documents in its presented form with 8 votes in favour and _o_votes against. · - -


Chairman: Dr. D. V. Doifode M.D. Onternal Medicine) 997015169~

Secretary: Dr. Sunil Gupta M.D., FIAMS, FIACM, FICP. Diabetologist 9823152111

Members: Dr. lndu Arneja M.D. (Pathology)





Mr. Subhash Jobaitputra B.Sc.

Mrs. Manisha R. Andulkar M.A., B.F.A .

•

42, Lendra Park, Ramdaspeth, Nagpur - 440 010, M.S., India Phone : +91 712-2428111,2428222, 2428333, Fax: +91 -712-2428555


We hereby confirm that neither you nor any of your study team members have participated in voting/decision making procedure of the committee. The members of the committee who have participated in the voting/decision making procedure of the committee do not have any conflict of interest in the referenced study.

The Ethics Committee of Diabetes Care n' Research Centre expects to be informed about:

1. The progress of the study annually. 2. Any SAE occurring in the course of the study. 3. Any changes in the protocol and patient information/informed·consent.

Also you are requested to provide a copy of the final report. This Ethics Committee is organized and operates according to Good Clinical Practice and Schedule Y requirements.

Yours truly,

(The Chairman) Ethics Committee of Diabetes Care n' Research Centre

:2-- l . J )-· 1 1 . Date:--------

I!:Ub ~of Diabetes Care n' Reaserch Centre

4Z Landra Park, Ramdaspeth NagpUr . 440010

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