Chairman: Dr . D. V . Doifode M.D. (Internal Medi cine) 9970151696 Secretary : Dr . Sunil Gupta M.D ., FIAMS, FIACM, F ICP. Diabetologi st 982315 2lll Members: Dr. I ndu A rneja M.D. (Pathology) Dr. Ashok Tank M.D. (For ensic Medic ine) Dr. Manohar Wan khede M.B .B. S. Mr. Umesh Sharma B. Com. Mr. Jitendra Ku rani B. Sc ., LLB. (Advocate) Mr. Sub hashJobanputra 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] mail@dcrcindia. com Date: 21 Dec 2011 To, Dr. Sunil Gupta Diabetes Care n' Research Centre Pvt. Ltd., 42, Lendra Park, Ramdaspet h, Nagpur- 440010, Maharashtra, India Reference:Study Code: EFC11319: A randomized, double-blind, placebo- controlled, parallel-group, multicenter study to evaluate cardiovascul ar 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, Maharasht ra, India. Sr. Documents Vers i on 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 Fi nal version 5.0 dated 31 Aug 2011 e-CRF 9 Informed consent form Version no. 2.0.1 dated 17 Feb 20 1-1 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, M rs. Manisha R. And u lkar M.A., B.F .A. informed consent form-Hindi translation dated 18 Feb 2011 ,@,v 141tJWNtJi.iK1tJilliM\jltJi
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Dr. D. V. Doifode · 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.
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Chairman: Dr. D. V. Doifode M.D. (Internal Medicine) 9970151696
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
~Diabetes ,@,v 141tJWNtJi.iK1tJilliM\jltJi
Chairman : Dr. D. V. Doifode M.D. (Internal Medicine) 9970151696
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 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
~Diabetes ,®;:~ IMJ!iritJ,111flllliMitll
Chairman: Dr. D. V. Doifode M.D. (Internal Medicine) 9970151696 -
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