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---~-...--... --.- ----,----- The CHILDS Trust Medical Research Foundation ~ 12-A, Nageswara Road, Nungambakkam, Chennai - 600 034, . ,-::-:, .'" Phone : 4200 1800 JJJ",of.K.Mathangi Ramakrishnan, M.8;FRCS(Eng).,FRCS(Edn).,MCH(Plastic ).,Dsc,Dsc{ (Hon.CAUSA)8HU} FAMS, DIRECTOR, Intensive Paediatric Bums Care Unit & Department of Plastic Surgery, CHAIRPERSON - The CHILDS Trust Medical Research Foundation, K.K.CHILD Trust Hospital, Chennai - 600 034. Former Professor of Plastic Surgery,Kilpauk Medical College, Chennai - 600010 Former Emeritus Scientist, Central Leather Research Institute, Chennai - 600020 Tel: Res: +91-44-28275203, Hos: +91-44-42001800 ext.604 Email: [email protected] To, Dr. S. Balasubramanian Senior Consultant Pediatrician Kanchi Kamakoti CHILDS Trust Hospital Chennai-34 Ref: Study Name & No.: (DTPa-HBV-IPV-119)/ 111157 31-07-2012 Study title: "A Phase III, open-label, randomised, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals' combined DTPa-HBVIPV/ Hib vaccine (Infanrix hexa) administered to Indian infants according to a 6-10-14 weeks and a 2-4-6 months schedule." SUB: Ethics committee approval letter. Dear Sir, The following documents were reviewed & approved: Sr. D tV· No ocumen s erSlOn 1 Protocol-Amendment Dated 10 January 2012 2 Investigator Brochure Edition 6 dated May 2008 Informed consent form : 3 Final Indian English (modified as per KKCT, Chennai) ICF Dated 29/Feb/2012 Version Number 02, Dated: 29/FEB/20 12, based on Final Indian English ICF Version Number 02, Dated: 17/JAN/2012 Final Indian English (modified as per KKCT, Chennai) ICF Version Number 02, Dated:29/FEB/2012, based on Final:. \.·k i( k. r. 4 Indian English ICF Dat~.d-29/Feb/2012~>·~· / Version Number 02, Dated: 17/JAN/2012Translated from ... '. '._, English to Tamil on 12 Mar 2012 '* ~'. " !\ ~-, ::.. t, '. ~~ ;.~: ~~r; Ii ::. , . "::
Transcript of example.com › Clinicaltrials › WriteReadData › ethic › 8351326019EC... · Former Professor...
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The CHILDS Trust Medical Research Foundation ~12-A, Nageswara Road, Nungambakkam, Chennai - 600 034, . ,-::-:,.'"
Phone : 4200 1800
JJJ",of.K.Mathangi Ramakrishnan,M.8;FRCS(Eng).,FRCS(Edn).,MCH(Plastic ).,Dsc,Dsc{ (Hon.CAUSA)8HU} FAMS,DIRECTOR, Intensive Paediatric Bums Care Unit & Department of Plastic Surgery,CHAIRPERSON - The CHILDS Trust Medical Research Foundation,K.K.CHILD Trust Hospital, Chennai - 600 034.Former Professor of Plastic Surgery,Kilpauk Medical College, Chennai - 600010Former Emeritus Scientist, Central Leather Research Institute, Chennai - 600020Tel: Res: +91-44-28275203, Hos: +91-44-42001800 ext.604Email: [email protected]
To,
Dr. S. BalasubramanianSenior Consultant Pediatrician
Kanchi Kamakoti CHILDS Trust HospitalChennai-34
Ref: Study Name & No.: (DTPa-HBV-IPV-119)/ 111157
31-07-2012
Study title: "A Phase III, open-label, randomised, multicentre study to evaluate theimmunogenicity and safety of GlaxoSmithKline Biologicals' combined DTPa-HBVIPV/Hib vaccine (Infanrix hexa) administered to Indian infants according to a 6-10-14 weeksand a 2-4-6 months schedule."
SUB: Ethics committee approval letter.Dear Sir,The following documents were reviewed & approved:
Sr. D tV·No ocumen s erSlOn
1 Protocol-Amendment Dated 10 January 2012
2 Investigator Brochure Edition 6 dated May 2008
Informed consent form :
3 Final Indian English (modified as per KKCT, Chennai) ICF Dated 29/Feb/2012Version Number 02, Dated: 29/FEB/20 12, based on FinalIndian English ICF Version Number 02, Dated: 17/JAN/2012
Final Indian English (modified as per KKCT, Chennai) ICFVersion Number 02, Dated:29/FEB/2012, based on Final:. \.·k i( k. r.
4 Indian English ICF Dat~.d-29/Feb/2012~>·~· /Version Number 02, Dated: 17/JAN/2012Translated from ... '. '._,English to Tamil on 12 Mar 2012 '*
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Final Indian English (modified as per KKCT, Chennai) ICFVersion Number 02, Dated:29/FEB/20I2, based on Final Indian5English ICF Dated 29/Feb/20I2
Version Number 02, Dated: I7/JAN/20I2Translated from English to Telugu on 09 Mar 2012Final Hindi (modified as per KKCT, Chennai) ICF version6
number 01 dated 29/Feb/2012; based on Final Indian
Dated 29/Feb/2012English lCF version number 2.0 dated 29/Feb/20I2
Translated from English to Hindi on 20th March 20127
Subject card English Version 06 oct 2010
8
Subject card Hindi Translated from English to
Hindi on 24th May 20119
Subject card TamilTranslated from English to
Tamil on 28th March 2012
10
Subject card Telgu Translated from English to
Telgu on 28th March 201211
Diary card Dose 1,2,3- English 18m March 2011
12
Diary card Dose 1,2,3- Translated from English to Hindi 6m April 2011
13
Diary card Dose 1,2,3- Translated from English to Tamil 28m March 2012
14
Diary card Dose 1,2,3- Translated from English to Telgu 28m March 2012
15
Periodic safety report (PSRI's)Between 01 May 2010 to
30Apr 201216
Sample workbook for 6,10,14 group ~~/~~:.>~~j.-:::";~""~::':"",13 January 2012••.. c:.. .... ' .-'''.in
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17Sample workbook for 2,4,6 group '1",' \~'-
_.,':"1"(',,)3 January 2012/",·0 - ,.,,-~. _::t ,: , ••- -----.. ",
18Use of Human samples form t;,' ~"1' ,/' M~rch 18,201 Ih .~'/
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.-.,\(: ('.-"19 Insurance certificate
,j 12 //\ ,/
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\ 31/1212012,"
20 CV & Undertaking' ~;!'i \i':~)\'i \ .",' ~."-'
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\.~.')":..:..(-,21 Central Drugs laboratory (CDL) -Batch clearance'~~"'<" \
','20-Jul -2011,,'
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DCGI Approval letter 0,.,.:. ~,29'!;.Dec 2011(; '<>~:.,. ,.'':~.
- -".
Prof.K.Mathangi Ramakrishnan,M.B;FRCS(Eng).,FRCS(Edn).,MCH(Plastic ).,Dsc,Dsc{ (Hon.CAUSA)BHU} FAMS,DIRECTOR, Intensive Paediatric Bums Care Unit & Department of Plastic Surgery,CHAIRPERSON - The CHILDS Trust Medical Research Foundation,KKCHILD Trust Hospital, Chennai - 600 034.Former Professor of Plastic Surgery,Kilpauk Medical Col1ege, Chennai - 600010Former Emeritus Scientist, Central Leather Research Institute, Chennai - 600020Tel: Res: +91-44-28275203, Hos: +91-44-42001800 ext,604Em
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,----.-.
The CHILDS Trust Medical Research Foundation ~12-A, Nageswara Road, Nungambakkam, Chennai - 600 034. ~:; •• •II
Phone: 4200 1800
Prof.K.Mathangi Ramakrishnan,M.B;FRCS(Eng).,FRCS(Edn).,MCH(Plastic ).,Dsc,Dsc{ (Hon.CAUSA)BHU} FAMS,DIRECTOR, Intensive Paediatric Bums Care Unit & Department of Plastic Surgery,CHAIRPERSON - The CHILDS Trust Medical Research Foundation,
K.K.CHILD Trust Hospital, Chennai - 600 034.Former Professor of Plastic Surgery,Kilpauk Medical College, Chennai - 600 010Former Emeritus Scientist, Central Leather Research Institute, Chennai - 600 020Tel: Res: +91-44-28275203, Hos: +91-44-42001800 ext.604
Email: [email protected]
The following members of the ethics committee were present at the meeting held on
27-7-2012
Names QualificationAffiliationK.G.Kamala
M.D., DchConsultantChairman ofPaediatrician
Ethics Committee
Dr .K.Mathangi RamakrishnanM.B.F.R.C.S.,F.R.C.S.E,EmeritusProfessorSecretary IMember
Mch, D.Scof Plastic Surgery,Of Ethics
TamilNaduDr.
M.G. R University,ChennaiDr.AndalM.D., DchHOD .PaediatricsClinician
Medicine, KKCTHDr. H. Nalini ManuelM.A. Phil, Ph.D(Soc)Social WorkerSocial Scientist!
"Former ProjectRepresentativeof
Co-oridinatorofnon-governmental
"ASHA"voluntary agency
TheCentrefor
rehabilitationDr. Mary BabuM.Sc.,Ph.DDeputyBasic M~dical
Director(F ormerly)
ScientistsCentral
LeatherResearch
Institute,ChenmiiMr.S .A.Balasubramanian
B.A.B.L.,AdvocateLegal expertMember of ECMrsJ.Gowri Sridhar
B.Sc (Geography)StenographerLayperson from thecommunity
We approve the trial to be conducted in its presented form.
The given approval is valid for the entire period of the study.
,----.-.
The CHILDS Trust Medical Research Foundation ~12-A, Nageswara Road, Nungambakkam, Chennai - 600 034. ~:~~ •• •II
Phone: 4200 1800
Prof.K.Mathangi Ramakrishnan,M.B;FRCS(Eng).,FRCS(Edn).,MCH(Plastic ).,Dsc,Dsc{ (Hon.CAUSA)BHU} FAMS,DIRECTOR, Intensive Paediatric Bums Care Unit & Department of Plastic Surgery,CHAIRPERSON - The CHILDS Trust Medical Research Foundation,
K.K.CHILD Trust Hospital, Chennai - 600 034.Former Professor of Plastic Surgery,Kilpauk Medical College, Chennai - 600010Former Emeritus Scientist, Central Leather Research Institute, Chennai - 600 020Tel: Res: +91-44-28275203, Hos: +91-44-42001800 ext.604
Email: [email protected]
The following members of the ethics committee were present at the meeting held on
27-7-2012
Names QualificationAffiliationK.G.Kamala
M.D., DchConsultantChairman ofPaediatrician
Ethics Committee
Dr .K.Mathangi RamakrishnanM.B.F .R.C.S.,F .R.C.S.E,EmeritusProfessorSecretary/Member
Mch, D.Scof Plastic Surgery,Of Ethics
TamilNaduDr.
M.G. R University,ChennaiDr.AndalM.D., DchHOD .PaediatricsClinician
Medicine, KKCTHDr. H. Nalini ManuelM.A. Phil, Ph.D(Soc)Social WorkerSocial Scientist!
"Former ProjectRepresentativeof
Co-oridinatorofnon-governmental
"ASHA"voluntary agency
TheCentrefor
rehabilitationDr. Mary BabuM.Sc.,Ph.DDeputyBasic M~dical
Director(F ormerly)
ScientistsCentral
LeatherResearch
Institute,ChennaiMr.S .A.Balasubramanian
B.A.B.L.,AdvocateLegal expertMember of ECMrsJ.Gowri Sridhar
B.Sc (Geography)StenographerLayperson from thecommunity
We approve the trial to be conducted in its presented form.
The given approval is valid for the entire period of the study.
The CHILDS Trust Medical Research Foundation ~12-A, Nageswara Road, Nungambakkam, Chennai - 600 034. ~=;:~:~,
Phone: 4200 1800
Prof.K.Mathangi Ramakrishnan,M.B;FRCS(Eng).,FRCS(Edn).,MCH(Plastic ).,Dsc,Dsc{ (Hon.CAUSA)BHU} FAMS,DIRECTOR, Intensive Paediatric Bums Care Unit & Department of Plastic Surgery,CHAIRPERSON - The CHILDS Trust Medical Research Foundation,
K.K.CHILD Trust Hospital, Chennai - 600 034.Former Professor of Plastic Surgery,Kilpauk Medical College, Chennai - 600010Former Emeritus Scientist, Central Leather Research Institute, Chennai - 600 020Tel: Res: +91-44-28275203, Hos: +91-44-42001800 ext.604
Email: [email protected]
The Institutional Ethics Committee expect to be infonned about the progress of the
study 6 months, in addition to any SAE occuning in the course of the study, any
changes in the protocol and patient informationlinfonned consent and asks to be
provided a copy of the final report.
Dr. S.Balasubramanian, Sr. Conslt.Pediatrician, Kanchi Kamakoti CHILDS Trust
Hospital, Chennai-34 being the Principal Investigator did not participate in the decision
making for the study.
I hereby certify that this committee is organized and operates according to ICH GCP guidelinesand at the time of the voting the required quorum was present.
Yours sincerely,
L, Q'fL{1crSecretary/Member of
Ethics Committee.
.M,-
