OSMANIA MEDICAL COLLEGE Koti, Hyderabad-500 095 A.P. India. Phones:(040)24656992,24656193,24656664,24656936 Direct: (040) 24651936, F~: (040) 24651936 ETHICS COMMITTEE (ESTD. .1846) Chairman : Justice P.C. Reddy Member : Dr. Suhasini Reddy Retd. Chief Justice. Hjsh Court of A.P. Retd. Dirctor of IPM Convenor : Dr.(Capt) C. Siddappa Gowrav Member : Sri. V. K. Srinivasan IAS' Principal.Osmania Medical College, Hyd. Retd. Special Chief Secldary Member ; Dr. C.S. Bhaskaran Member : 8m'!. C.V. Vinitha Reddy Former Vice Chancellor NTR UHS Advocate Retd. DME & HOD of Microbiology Member : Smt. N. Usha Reddy Committee Member Andhra Mahila Sabha --- MINUTES OF ETHICS COMMITTEE: OSMANIA MEDICAL CO LEGE HYDERABAD HELD ON 28-05-2011 5 Title ofProiect "An Open Label, Randomized, comparison of the Immunogenlcity and Safety ofWockhardt's Human Insulin Basal Bolus Regimen {Intensified Conventional Insulih Therapy with Soluble Insulin and Isophane Insulin (Wosulin R, Wosulin Nand Wosulin 70/30)} with the Novo Nordisk's yeast based Human Insulin Basal Bo: 3Regimens, marketed in United States (Novolin@ R, Novolin@ Nand Novolin@ 70/30) in Type 1 Diabetics ." Protocol No. P3- WOS-IMS-Ol . Sponsor MIs Wochardt Ltd Wockhardt Towers, Bandra Kurla Complex Bandra (East), Mumbai - 400 051 Investigator Dr. Rakesh Kumar Sahay Professor of Endocrinology Osmania Medical College 1 Osmania General Hospital, Hyderabad Co-investigator ------------ Investigation site : Department of Endocrinology Osmania General Hospital, Hyderabad Duration of trial : 1year Drug Controller General ofIndia Permission Ref: F.No: CT/294/l0-DCG (1) Dated: 22-03-2011 The following members of the ethics committee were present at the meeting held on 28-05-2011 at 11.00 am at Osmania Medical College, Hyderabad. : Justice P. C. Reddy, Chairman, Ethics committee Dr. (Capt) C. Siddappa Gowrav, Convenor (Member Secretary). Dr. C. S. Bhaskaran, Member Dr; Suhasini Reddy, Member Smt. C. V. Vinitha Reddy, Member Dr. N. Usha Reddy '-The following documents were reviewed: Document Version date l identifier 1. Protocol Version 5, dated 22M Sep 2010 2. Investigator Brochure Edition No. IB/US-02-00 dated 15111Feb 2010 3. Pack Inserts for Wosulin Wosulin N, Wosulin R, Wosulin 30/70 OSMANIA MEDIC,AL COLLEGE Koti, Hyderabad-500 095 A.P. India. Phones :(040)24656992,24656193,24656664,24656936 Direct: (040) 24651936, Fax: (040) 24651936 ETHICS COMMITTEE Member : Dr. Suhasini Reddy Chairman Retd. Dirctor of IPM Member : Sri. V. K. Srinivasan IAS Convenor Retd. Special Chief Secldary Member : 8m'!. C.V. Vinitha Reddy Member Advocate Member : Smt. N. Usha Reddy Committee Member Andhra Mahila Sabha 4. Pack Inserts for Novolin Novolin N, Novolin R, Novolin 30/70 - Version 5, dated 14thMay 2010 5. Informed Consent Document - English, Hindi, Telugu & Translation Version 1, dated 27''' Sep 2010 Certificate 6. Back Translations ofICD from Hindi, Version 1, dated 27th Sep 2010 Telugu & Back Translation- - __Certificate. -0-- 7. Patient Diary - English, Hindi, Telugu, Dated 20th Sep 2010 & Translation Certificate .. 8. Patient Card sample 9. Case Report Form Dated Iltl1Dec 2010 10. Insurance Policy 4067/61446586/001000 11. Indemnity Policy 4022/63172197/001000 12. .DCGI Approval letter Dated 22"°-March-2011 13 Investigators Undertaking Dated 04tl1_March-2011 14. CV of Principal Investigator 19t\ -August- 2010 15. Confidentiality Agreement 28tl1-Feb-2011 16. Clinical Trial agreement Version 10-12-2010 The committee after critical review and discussion of the documents, approved the clinical trial at the Department of Endocrinology, Osmania General Hospital, Hyderabad by Dr. Rakesh Kumar Sahay, Professor of Endocrinology, Osrhania Medical College 1 Osmania General Hospital, Hyderabad, (Principal Investigator). The permission is valid till 30thJune 2012. I Terms of aoproval: 1. The Principal investigator is further requested to follow the Ethical aspects of the clinical trial as described in the booklet "Ethical Guide Line for Bio-Medical Research on Human subjects" published by Indian Council of Medical Research, New Delhi. Ethics Committee works as per the ICHIGCP guidelines and their SOP's .. 2. If the biological samples collected from patients in the study are to be sent overseas for any ,purpose, the necessary permission should be obtained from the appropriate authorities of the Govt. ofIndia. The Prindpal Investigator shall ensure that this condition is fulfilled as and when required and the same to be informed to the IEC by the Principal Investigator. OSMANIA MEDICAL COLLEGE Koti, Hyderabad-500 095 A.P. India. Phones :(040)24656992,24656193,24656664,24656936 Direct: (040) 24651936, Fax: (040) 24651936 ETHICS COMMITTEE (ESTD. .1846) Chairman : Justice P.C. Red6y Member : Dr. Suhasini Reddy Retd. Chief Justice. High Court of A.P. Retd. Dirctor of IPM : Sri. V. K. Srinivasan IAS Convenor : Dr.(Capt) C. Siddappa Gowrav Member Principal, Osmania Medical College, Hyd. ReId. Special Chief SeGidary Member : Dr. C.S. Bhaskaran Member : Sm1. C.V. Vinitha Reddy Former Vice Chancellor NTR UHS Advocate Retd. DME & HOD of ~icrobiology Member : Smt. N. Usha Reddy Committee Member Andhra Mahila Sabha 3. The Principal investigator shall communicate any adverse events occurring at his/her investigational site or other SAEs brought to his/her notice by the sponsor during the course of the study to the IEC immediately, 4. The lEC shall review the progress of the study every lyear till completion report at the end of the clinical trial. 5. In informed consent form, it is provided that the patient will be informed that he/ she will be reimbursed for traveling expenses per visit. Therefore the patient should be informed before his/her participation in the study in that he/she will be paid towards his/her travel expenses Rs : 200/- per visit. .~ Justice P. 'to Reddy r. (Capt) C. Siddappa Gowrav Chairman Member secretary Ethics Committee Ethics Committee k -cA ~ '-~-LtVl Dr. C. S. Bhaskaran ~ Member MemberDr. Sushasini Reddy . ~. - ( r)"- .v.u~~ r/. ~ 16-r-yj, \ Smt. C. V. Viriitha Reddy Smt. N. Usha Reddy f Member Member Copy to: Dr. Rakesh Kumar Sahay, Professor of Endocrinology, OMC/ OGH, Hyderabad..