KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES

KEMPEGOWDA
INSTITUTE OF MEDICAL SCIENCES
(Affiliated
to Bangalore University, Rajiv Gandhi University of Health Sciences
& recognised by Medical Council of India, New Delhi)
2ND STAGE,
BANGALORE
- 560 070
BANASHANKARI
PH. COLLEGE OFFICE: 080-26712791,
26712792,
FAX: 080-26712798
HOSPITAL OFFICE: 080-26679560,
26679202
FAX: 080-26613225
website:
www.kimscollege.org
Email:.bngkims@kar.nic.in
From,
The member secretary,
Institutional Ethics Committee,
Kempegowda Institute of Medical Sciences,
Bangalore.
Date: 17/01/11
To,
Dr. H. N. Sowbhagya,
Professor,
Department Ophthalmology,
KIMS, Bangalore.
Study title: A Multi Center, Open Label, Randomized, Two-Treatment, Two-Sequence, Single
Period, Parallel, Single Dose, Bioequivalence Study To Compare The Pharmacokinetics Of
Marketed Product TobraDex® (Tobramycin And Dexamethasone Ophthalmic Suspension) To
An Experimental Ophthalmic Sterile Suspension Containing Tobramycin 0.3% And
Dexamethasone 0.1 % W N In Aqueous Humor In Patients Undergoing Indicated Cataract
Surgery. Protocol No: S-10-039
Dear Dr. H. N. Sowbhagya,
With reference to the above mentioned study, the following documents were received from you
and the same has been reviewed by us
Tamil
Version
No:
AndVersion
Date Number 3.0 Dated:30-Nov-2010
Informed
Consent
Form
In
Documents
Kannada
Dated 07 Dec 2010
S.No Clinical
Back
Translation
Form
Malayalam
Study
Protocol
Kannada
Hindi
to English
to English
Informed
Consent
FormTamil
In Hindi
English
yrics
10.
CRF
Number
NA
Version
Dated: 08-Dec-2010
Number
2
2.0
DCGI
Informed
Certificate
Submission
Consent
ofVitae
Insurance
Form
Letter
In Urdu
3.0 Dated:22-Dec-2010
Dated:30-Nov-2010
Back
Translation
Form
to English
Product
Source
Note
Monograph.
template
Malayalam
to English
Undertaking
Site
Specific
by
SOP
the
Investigator.
Curriculum
Clinical
Study
Protocol
of
the Urdu
Administrative
Principal
15.
16.
The following members of the Ethics Committee were present during the meeting held at ..KIMS
CONFERENCE HALL. on 30/12/2010. at ... 11.00 AM and have decided to approve the above
mentioned documents for use in referenced study.
Smt.
Poornamma
Socialof
worker
Dr.M.K.Sudarshan
Dr.
ofLalitha
Associate
Dr.K.Ananda
HOD
and
Dr.H.Pundareekaksha
Prof.
Himalakshi
ofof
DeanKIMS
Profand
.prof
Prof
sociology
S.NoMember
Name
of Member
Qualification
Kalavathi
Medical
superintendent
Member
secretary
community
Dr.Keshava
Dr.AnjanapP'a
murthy Member
S
surgery
Designation
and
HOD,Forensic
Member
Member
Chair person
We confirm that neither you nor your study team members participated in the deliberations of the
Ethics Committee & did not vote on the proposal for this study.
Thanking you,
A. '.
.0"
.•
mber h'
Secretary
Comrth\ 0
·tutional ~t Icsf Mettle I $t\once
owda Institute 0 010
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