Embed Size (px)
Citation preview
NARAYANANETHRALAYA-- your faith shall heal you --
Super Speciality Eye Hospital &Post Graduate Institute of Ophthalmology
Date:03-May-2010
To,Dr. Somsbekhar NNarayana Nethralaya,1211C, Chord Road, Rajajinagar,1st 'R' Block,Bangalore-560010, India
Ref: Protocol C-07-53: An Evaluation of the Efficacy and Safety of AL-46383A OphthalmicSolution for the Treatment of Adenoviral Conjunctivitis.
Sub: Ethics Committee approval for the conduct of the referenced study at NarayanaNethralaya, 1211C, Chord Road, Rajajinagar,1st 'R' Block,Bangalore-560010, India andapproval of study related documents.
Dear Dr. Somshekhar,
We have received from you 13 copies of each of following study related documents providedyour letter dated: 16-Apr-2010
U IV ocnmen s
1. Protocol Protocol No. C-07-53, Version Current 3.0, dated IS-Feb-2010,
2. Investigator's BrochureInvestigator's Brochure Version Current 3.0 dated 15 May 2009
Manual of Procedures Version Current 1.0 dated 22-Feb-20103. Manual of Procedures Including:
Standard photographs: Bulbar Conjunctival Injection scale
4. Parental Permission I India Parental Permission I Participant Informed Consent Form Version V02INDO 1.Participant Informed C0753T062vOI dated 12 March 2010/ Dr. Somshekhar NConsent Form
Kannada Parental Permission I Participant Informed Consent Form Versiona. English ICF V02IND01. C0753T062vOl dated 19 March 2010/ Dr. Somshekhar N
b. KannadaICF Kannada Parental Permission I Participant Informed Consent Form VersionV02INDOl.C0753T062vOI dated 19 Mar 2010lBack-translated from Kannada to
c. Kannada BT ICF English on 08 Apr 2010 by Subramanya RaolDr. Somshekhar N
d. TamillCF Tamil Parental Permission I Participant Informed Consent Form VersionV02INDOl.C0753T062vOl dated 15 Mar 20101Dr. Somshekhar N
e. T~l1lH IH ,Clf I
Tamil Parental Permission I Participant Informed Consent Form Versionf. T~J~"mICf Y02INDOl.C0753T062vOI dated 15 Mar 20 1OlBack-translated from Tamil to
St d d t
NN 1 :121/C, Chord Road,
Rajajinagar,1st 'R' Block,
Bangalore-560 010.Ph: 91-80-66121300-1305, 1400-1404
Fax: 91-80- 23377329Mobile: 9902546046 (Emergency only)
NN 2:Narayana Health City
(Narayana Hrudayalaya Campus)# 258/A, Bommasandra, Hosur Road
Bangalore-560 099. INDIA.Phone: 91-80-66660655-658
Fax: 91-80-66660650Mobile: 99028 21128 (Emergency only)
Page 1 QfS
,"Emall- [email protected]
[email protected] - www.narayananethralaya.org_•.
NETHR.ALAYA English on 02 Apr 2010 by VelulDr.Somshekhar N-- your faith shall heal you --
Super Speciality Eye Hospital &Post Graduate Institute of 0ifthalmOIOgy
TeluguParental Permission 1Participant Informed Consent Form Versiong. Telugn B ICFV02INDOI C0753T062vOI dated 15 Mar2010IDr.SomshekharN
Telugu Parental Permission 1Participant Informed Consent Form Versionh. Malayalam ICF V02IND01.C0753T062vOI dated 15 Mar 20 1OlBack-translated from Telugu to
English on 02 Apr 2010 by YaUapragada Aruna/Dr. Somshekhar N
I. Malayalam BT ICF Malayalam Parental Permission I Participant Informed Consent Form VersionV02IND01.C0753T062vOl dated 17 Mar 201OIDr.Somshekhar N
Malayalam Parental Permission 1Participant Informed Consent Form VersionV02IND01.C0753T062vOl dated 17 Mar 2010lBack-translated from Malayalam toEnglish on 12 Apr 2010 by JaishreeDr. Somshekhar N
5. Informed ConsentForm - Assent Form forChildren (Ages 6-9)
a. English India Assent Form for Children (Ages 6-9) Version VOlIN DOl .. C0753T062vOIdated 12 March 20101 Dr. Somshekhar N
b. Kannada ICF Kannada Assent Form for Children (Ages 6-9) VersionVOIIND01.C0753T062vOI dated 17 Mar 201OIDr.Somshekhar N
c. Kannada BT ICF Kannada Assent Form for Children (Ages 6-9) Version VOIINDOl.C0753T062vOIdated 17 Mar 20 1OlBack-translated from Kannada to English on 08 Apr 2010 bySubramanya Rao/Dr. Somshekhar N
d. TamilICF Tamil Assent Form for Children (Ages 6-9) Version VO1INDOl.C0753T062vO 1dated 15 Mar20101Dr.SomshekharN
Tamil Assent Form for Children (Ages 6-9) Version VOIIND01.C0753T062vOIe. TamilBTICF dated 15 Mar 2010lBack-translated from Tamil to English on 02 Apr 2010 by
VelulDr.Somshekhar N
Telugu Assent Form for Children (Ages 6-9) Version! VOIINDOl_ C0753T062vOIf. Telngu ICF dated 15 Mar 20 1OIDr. Somshekhar N
g. Telugu BT ICF Telugu Assent Form for Children (Ages 6-9) Version VO1INDO l.C0753T062vOldated 15 Mar 201OlBack-translated from Telugu to English on 06 Apr 2010 byYaUapragada ArunaIDr.Somshekhar N
h. Malayalam ICF Malayalam Assent Form for Children (Ages 6-9) Version VOI1NDOl.C0753T062vOldated 17 Mar 201 OIDr.Somshekhar N
i. Malayalam BT ICF Malayalam Assent Form for Children (Ages 6-9) Version V01IND01.C0753T062v01dated 17 Mar 201 OlBack-translated from Malayalam to English on 08 Apr 2010 by
NN 1 :121/C, Chord Road,
Rajajinagar,1st 'R' Block,
Bangalore-560 010.Ph: 91-80-66121300-1305,1400-1404
Fax: 91-80- 23377329Mobile: 9902546046 (Emergency only)
NN 2:Narayana Health City
(Narayana Hrudayalaya Campus)# 258/A, Bommasandra, Hosur Road
Bangalore·560 099. INDIA.Phone: 91-80-66660655-658
Fax: 91-80-66660650Mobile: 99028 21128 (Emergency only)
Page 2 of5
Email- [email protected]@narayananethralaya.com
Website - www.narayananethralaya.org_•.
NETHRAlAYA Jaishree/Dr. Somshekhar N-- your faith shall heal you --Super Speciality Eye Hospital &
Post Graduate InstiMe of Ophthalmology
6. Informed ConsentForm - Assent Form forMinors (Ages 10-17) India Assent Form for Minors (Ages 10-17) Version VOJINDOJ.C0753T062vOI dated
English12 March 2010/ Dr. Somshekhar N
a.
h. KannadaICFKannada Assent Form for Minors (Ages 10-17) Version V01lNDO l.C0753T062vO 1dated 17 Mar 201 OlDr.Somshekhar N
c. Kannada BT ICF Kannada Assent Form for Minors (Ages 10-17) Version V01lND01.C0753T062vOldated 17 Mar 201 OlBack-translated from Kannada to English on 08 Apr 20 10 bySubramanya RaolDr. Somshekhar N
d. TamilICFTamil Assent Form for Minors (Ages 10-17) Version VOIlNDO 1.C07 53T062vO 1dated 15 Mar20lOlDr. SomshekbarN
e. Tamil BT ICFTamil Assent Form for Minors (Ages 10-17) Version VOllND01.C0753T062vOldated] 5 Mar 2010lBack-translated from Tamil to English on 02 Apr 2010 byVelulDr. Somshekhar N
f. Telugu ICFTelugu Assent Form for Minors (Ages 10-17) Version VOIlNDO 1. C0753T062vOIdated 15 Mar 20lOlDr. Somshekbar N
g. Telugu BT ICFTelugu Assent Form for Minors (Ages 10-17) Version VOllNDOl.C0753T062vOIdated 15 Mar 20lOlBack-translated from Telugu to English on 06 Apr 2010 byBalakrishna VardhanapuiDr. Somshekhar N
h. Malayalam ICFMalayalam Assent Form for Minors (Ages 10-17) VersionVOllND01.C0753T062vOI dated 17 Mar2010/Dr. Somshekhar N
Malayalam Assent Form for Minors (Ages lO-17) Version
i. Malayalam BT ICFVOIlNDOl.C0753T062vOI dated 17 Mar 201 O/Back-translated from Malayalam toEnglish on 08 Apr 2010 by Jaishree/Dr. Somshekhar N
7. Dosing Dairy Englisha. English
Translated from English to Kannada on 19 Mar 2010 by Ganesh Bhath. Kannada Kannada DOSING DIARY
Kannada Dosing Diaryc. KannadaBT Back-translated from Kannada to English on 08 Apr 2010 by Subramanya Rao
d. Tamil Translated from English to Tamil on 15 Mar 20lO by David Paul SamsonTamil DOSING DIARY
NN 1 :121/C, Chord Road,
Rajajinagar,1st 'R' Block,
Bangalore-560 010.Ph: 91-80-66121300-1305, 1400-1404
Fax: 91-80- 23377329Mobile: 9902546046 (Emergency only)
Page 3 of5NN2 :Narayana Health City
(Narayana Hrudayalaya Campus)# 258/A, Bommasandra, Hosur Road
Bangalore-560 099. INDIA.Phone: 91-80-66660655-658
Fax: 91-80-66660650Mobile: 9902821128 (Emergency only)
Email - [email protected]@narayananethralaya.com
Website - www.narayananethralaya.org__ I
. -" ~
~NARAYANANETHRA~AYA-- your faith shall heal you --
Tamil Dosing DiarySuper Speciality Eye Hospital &Post Graduate Institute offhthalmOIOgy
e. Tamil B Back-translated from Tamil to English on 08 Apr 2010 by Sarva Bhouman
Translated from English to Telugu on 15 Mar 2010 by Balakrishna Vardhanapuf. Telugu Telugu DOSING DIARY
Telugu Dosing Diaryg. Telugu BT Back -translated from Telugu to English on 02 Apr 2010 by Yallapragada Aruna
Translated from English to Ma1aya1am on 17 Mar 2010 by Venugopalh. Malayalam Malayalam DOSING DIARY
Malayalam Dosing Diaryi. Malayalam BT Back-translated from Malayalam to English on 08 Apr 2010 by Jaishree
8. CRF C-07-53 Amended CRFs Endorsed Version 3.0 as of 09 March 20109. Vehicle Arm Vehicle Arm Justification Letter
Justification Letter10. English Flyer11. English Physician Referral Material
We are also in receipt ofthe following documents:-
• Your current, signed and dated CV as a token of credentials for the conduct of the studyas Principal Investigator.
• A list of the proposed study members, who will be working on this study at this instituteunder your supervision.
• A copy of the Investigator's Undertaking• Insurance Certificate• Excursion Memo for Aganocide• DCGI Acknowledged Initial Submission Letter dated 24 March 2010.
In addition, we have also noted details of the central laboratories involved in assessment of thesamples collected during the course of the study.
At the Ethics Committee meeting held on 30-Apr-20IO, your referenced letter and the abovedocuments were examined and discussed. After due consideration, the committee has decided toapprove the conduct of the aforementioned study under your direction at NarayanaNethralaya, 1211C, Chord Road, Rajajinagar, I" 'R' Block, Bangalore-560010, India andapprove the study related documents.
Please inform us in case any Serious Adverse Event is observed during the conduct of the studyand also let us have a periodic report on the progress of the study bi-monthly (as per the EC SOP)
We also request you to kindly notify and/or submit to Ee, if there is any new information in theICFs, protocol amendments and IDB should available.
We approve the assessments as specified in the clinical study protocol.
NN 1 :121/C, Chord Road,
Rajajinagar,1st 'R' Block,
Bangalore-560 010.Ph: 91-80-66121300-1305, 1400·1404
Fax: 91-80- 23377329Mobile: 99025 46046 (Emergency only)
NN2:, Narayana Health City
(Narayana Hrudayalaya Campus)# 258/A, Bommasandra, Hosur Road
Bangalore-560 099. INDIA.Phone: 91-80-66660655·658
Fax: 91-80-66660650Mobile: 99028 21128 (Emergency only)
Page 4 of5
Email - [email protected]@narayananelhralaya.com
Website - www.narayananethralaya.org__ I
NARAYANANETHRALAYA-- your faith shall heal you --
Super Speciality Eye Hospital &Post Graduate Institute of Ophthalmology
The members who attended the meeting held on 30-Apr-2010 at which 1m proposal wasdiscussed are listed below:
Name of the EC Role Designation Gender I Affiliation tomember the
Institution1.Dr.Sreevasta Chairman! Phd male No
Basic scientist (microbiology)2 .. Dr.Sri Bhargav Member secretary MBBS,DOMS, male
Iyes
Natesh DNB, FMRF3.Dr.Ravindra Bhattu Member MBBS, male yes
DO,MSI
4.Dr.T K Nagbhushan Member MBBS, male I NoM.D( GeneralMedicine)
5.Mr.Mahalinga Bhatt Member B.Sc, LLB. male NoI
6.Mrs.Vanaja Ram Dev Member B.A female I No
7.Dr.Keshav M Member MBBS,DVD male yes
8.Dr.Manjunath Member MBBS male I NoMarasndra ,DO,FRCS,FMRF9.Dr.Mahesh Member MBBS,DVD male yes
It is to be noted that neither you nOTany of your proposed study team members Lere presentduring the decision-making procedures of the Ethics Committee.
Please note that the Ethics Committee is formed and operating in compliance J~th the ICH-GCPand local regulatory requirements. l'
Date: -----------+-------o 6 MAVi2010I(Signature of Ethics Committee Chairman)
lnstituitional Ethics CommitteeNarayana Nethralaya
Bal1galore
NN 1:121/C, Chord Road,
Rajajinagar,1st 'R' Block,
Bangalore·560 010.Ph: 91·80·66121300·1305,1400·1404
Fax: 91·80· 23377329Mobile: 9902546046 (Emergency only)
NN2 :Narayana Health City
(Narayana Hrudayalaya Campus)# 258/A, Bommasandra, Hosur Road
Bangalore·560 099. INDIA.Phone: 91-80-66660655-658 Email- [email protected]
Fax: 91-80-66660650 [email protected]: 9902821128 (Emergency only) Website - www.narayananethralaya.org.••...•••_•.
