osmania medical college - example.com...cv of principal investigator 19t \-august- 2010 15....
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OSMANIA MEDICAL COLLEGEKoti, Hyderabad-500 095 A.P. India.
Phones:(040)24656992,24656193,24656664,24656936Direct: (040) 24651936, F~: (040) 24651936
ETHICS COMMITTEE(ESTD. .1846)
Chairman : Justice P.C. ReddyRetd. Chief Justice. Hjsh Court of A.P.
Convenor : Dr.(Capt) C. Siddappa GowravPrincipal.Osmania Medical College, Hyd.
Member ; Dr. C.S. BhaskaranFormer Vice Chancellor NTR UHSRetd. DME & HOD of Microbiology
Member
: Dr. Suhasini ReddyRetd. Dirctor of IPM
: Sri. V. K. Srinivasan IAS'Retd. Special Chief Secldary
: 8m'!. C.V. Vinitha ReddyAdvocate
: Smt. N. Usha ReddyCommittee MemberAndhra Mahila Sabha
Member
Member
Member
---
MINUTES OF ETHICS COMMITTEE: OSMANIA MEDICAL CO LEGEHYDERABAD HELD ON 28-05-2011 5
Title ofProiect "An Open Label, Randomized, comparison of the Immunogenlcity andSafety ofWockhardt's Human Insulin Basal Bolus Regimen {IntensifiedConventional Insulih Therapy with Soluble Insulin and Isophane Insulin(Wosulin R, Wosulin Nand Wosulin 70/30)} with the Novo Nordisk'syeast based Human Insulin Basal Bo: 3Regimens, marketed in UnitedStates (Novolin@ R, Novolin@ Nand Novolin@ 70/30) in Type 1Diabetics ."
Protocol No. P3- WOS-IMS-Ol
Investigator
MIs Wochardt Ltd
Wockhardt Towers, Bandra Kurla ComplexBandra (East), Mumbai - 400 051
Dr. Rakesh Kumar SahayProfessor of EndocrinologyOsmania Medical College 1Osmania General Hospital, Hyderabad
. . Sponsor
Co-investigator ------------
Investigation site : Department of EndocrinologyOsmania General Hospital, Hyderabad
Duration of trial : 1yearDrug 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 11.00am at Osmania Medical College, Hyderabad. :
Justice P. C. Reddy, Chairman, Ethics committeeDr. (Capt) C. Siddappa Gowrav, Convenor (Member Secretary).Dr. C. S. Bhaskaran, MemberDr; Suhasini Reddy, MemberSmt. C. V. Vinitha Reddy, MemberDr. 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
Chairman
Convenor
Member
OSMANIA MEDIC,AL COLLEGEKoti, Hyderabad-500 095 A.P. India.
Phones :(040)24656992,24656193,24656664,24656936Direct: (040) 24651936, Fax: (040) 24651936
ETHICS COMMITTEE
Member : Dr. Suhasini ReddyRetd. Dirctor of IPM
: Sri. V. K. Srinivasan IASRetd. Special Chief Secldary
: 8m'!. C.V. Vinitha ReddyAdvocate
: Smt. N. Usha ReddyCommittee MemberAndhra Mahila Sabha
Member
Member
Member
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 asdescribed 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 theICHIGCP 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 requiredand the same to be informed to the IEC by the Principal Investigator.
4. Pack Inserts for Novolin Novolin N, Novolin R, Novolin 30/70 - Version5, dated 14thMay 2010
5. Informed Consent Document -Version 1, dated 27''' Sep 2010English, Hindi, Telugu & Translation
Certificate6. 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
OSMANIA MEDICAL COLLEGEKoti, Hyderabad-500 095 A.P. India.
Phones :(040)24656992,24656193,24656664,24656936Direct: (040) 24651936, Fax: (040) 24651936
ETHICS COMMITTEE
Member
(ESTD. .1846)
: Justice P.C. Red6yRetd. Chief Justice. High Court of A.P.
: Dr.(Capt) C. Siddappa GowravPrincipal, Osmania Medical College, Hyd.
: Dr. C.S. BhaskaranFormer Vice Chancellor NTR UHSRetd. DME & HOD of ~icrobiology
Member
Member
: Dr. Suhasini ReddyRetd. Dirctor of IPM
: Sri. V. K. Srinivasan IASReId. Special Chief SeGidary
: Sm1. C.V. Vinitha ReddyAdvocate
: Smt. N. Usha ReddyCommittee MemberAndhra Mahila Sabha
Chairman
Convenor Member
Member
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/- pervisit.
.~Justice P. 'to ReddyChairmanEthics Committee
r. (Capt) C. Siddappa GowravMember secretaryEthics Committee
~ k -cA ~ '-~-LtVlDr. Sushasini Reddy . ~. - (Member
Dr. C. S. BhaskaranMember
r) .v.u~~"-
Smt. C. V. Viriitha ReddyMember
r/. ~ 16-r-yj, \
Smt. N. Usha Reddy f
Member
Copy to: Dr. Rakesh Kumar Sahay, Professor of Endocrinology, OMC/ OGH, Hyderabad.