KLE UNIVERSITY

KLE
UNIVERSITY
~~
KLE UNIVERSITY
[Established under Section 3 of the UGCAct, 1956 videMHRD, G.O.I Notification NO.F 9-19/2000-U.3{A) dl 13" April2006j
Office of the Registrar , KLE University,
JNMC Campus, Nehru Nagar, Belgaum-590 010, Karr:ataka State, India
tr: 0831-2472777 FAX: 0831-2493777 Web: http://www.kleuniversity.edu.in
E-mail : [email protected]
Ref: KLEU/EC/2012-13/D-
Date: 18/0612012
From,
Chairperson,
Ethics Committee ofKLE University, Belgaum
To,
Dr. S M Dhaded,
Professor & Head, Department of Pediatrics,
J.N. Medical College, KLE Deemed University.
Consultant, KLES Dr Prabhakar Kore Hospital & MRC,
Nehrn Nagar, Belgaum- 590010
Ref: Protocol Study:"Safety, Im mune Lot-to-Lot Con sistency and Non-Inferiority of Shan 5
(DTwP-HepB-Hib) Vaccine in Compar ison to Pentavac SD when administered as a Single Booster
Dose at 15-18 months and Three Dose at 6-8,10-12 and 14-16 Weeks of Age in Healthy Indian
Children and Infants" (protocol Number: SH501 Version 1.0, dated 14th April 2012)".
Sub: Ap~roval of Study Documents for the conduct of study Protocol Number: SH501, Version 1.0,
Dated 14t April 2012.
Dear Dr. S. M. Dhaded,
The Ethics Committee, KLE University, Belgaum has received from you 12 Copies of each of following
study related documents.
1. Research Protocol (Protocol Number: SH501, Version 1.0, dated 14th April 2012).
2. Investigator's.Brochure (Version 2, Dated 17th April 2012, which replaces Version 1, dated 24th
December 2007).
3. Case Report Form (Cohort 1&2)(Version 0.3, Dated 13.04.2012 Cohort 1), (Version 0.3, dated
13.04.2012, Cohort 2).
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4. Inform Consent Form (Cohort 1&2) English, Kannada, Marathi & Hindi (Version 1.0, dated 14
April 2012).
K L E
U N IVE RSITY
~PlICfEl:IQW.l
KLE UNIVERSITY
[Establishedunder Section 3 ofthe UGCAct, 1956vide MHRD, G,O.I Notification No,F.9-19/2000-U.3(A) dl 1311April 2006]
Office of the Registrar, KLE University,
JNMC Campus, Nehru Nagar, Belgaum-590 010, Kam ataka State , India
II : 0831-2472777 FAX: 0831-2493777
Web: http://www.kleuniversity.edu.in
E-mail: [email protected]
5. Symptoms Dairy Card (Cohort 1&2) English, Kannada, Marathi & Hindi.
6. CV of Investigator's.
7. Investigator' s undertaking.
8. Insurance Policy, 14-MAY-2012 to 30-APR-2013.
9. DCGI Approval submission letter Dated 13th April 2012 .
10. Translation Certificates:
th
•
English to Hindi (cohortl) Dated 14 April 2012.
•
English to Hindi (cohort2) Dated 14 April 2012.
•
English to Marathi (cohort 1) Dated 14 April 2012.
•
English to Marathi (cohort 2) Dated 16 April 2012.
•
English to Kannada (cohortl) Dated 14 April 2012.
•
English to Kannada (cohort2) Dated 14 April 2012.
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th
th
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At the Ethics Committee meeting held on Saturday 09 th June, 2012 at 03:00pm at Site
Management Office, KLES Dr Prabhakar Kor e Hospital & MRC, Belgaum.
Your referenced letter and the above submitted documents were examined and discussed.
Discussion Poi nts ­
The study is approved through 08/June/2013.
But the Investigator has to comply with the following prior to initiation of enrollment ­
• The study can be initiated only after the submission ofDCGI approval.
The members who attended the meeting held on Saturday 09th June, 2012 at 03:00pm at Site
Management Office, KLES Dr Prabhaka r Kore Hosp ital & M R C, Belgaum.
KLE
U N IVER SITY
~PIlCmlOWS
KLE UNIVERSITY
[Established under Section 3 ofthe UGC Act, 1956vide MHRD, G.O.INotificationNO.F.9-1912000-U.3IAl dt 1311April 2006]
Office of the Registrar, KLE University,
JNMC Campus, Nehru Nagar, Belgaum-590 010, Karnataka State, India
. : 0831-2472777 FAX: 0831-2493777 Web: http://www.kleuniversity.edu.in
E-mail: [email protected]
Following Members of the Committee were present:
1. Dr. Sanjiva Kholkute, Officer-in-Charge, RMRC, Belgaum
Chairman
2. Dr. Subarna.Roy , Scientist'D'Officer-in-charge, RMRC, Belgaum
Officiating
3. Dr. P. A. Pati!, Joint Director, KLE University Research Foundation
Member
4. Dr. Ashok C. Pangi, Prof of Surgery, JNMC, Belgaum
Member
5. Dr. S.M.Dhaded, Professor & HOD Dept of Pediatric, J.N.M.C, Bgm
Member
6. Mrs. Maki N. Kapadia, Social Worker, Havelock Road, Camp, Belgaum
Member
7. Mr. N.D.Kunne , Advocate & Receiver Bgm Dist.Court, Belgaum
Member
8. Mr. B.N.Metagudmath, Retd. Dy.SPs, Vigilance Officer, KLESH, Belgaum
Member
9. Dr. S.S.Goudar, Prof of Physiology, JNM C, Belgaum
Member - Secretary
Following Members of the committee who expressed their inability to attend / had not attended the
meeting were:
1. Dr. M. B. Bellad, ProfOBGYN, JNMC, Belgaum
Member
2. Dr. Sunita. Y. Patil, Associate Professor, Dept of Pathology, J.N.M.C, Bgm
Member
You are expected to report to the Ethics committee the following:
• All deviations from, or changes to, the protocol to eliminate immediate hazards to the study
subjects
• Changes that increase the risk to participating subjects and/or those that significantly affect the
conduct of the study
• All serious adverse events
• New information that may affect adversely the safety of the subjects or the conduct of the study
• Any changes in the study document
•
Progress of the study.
Also please provide a report to the Ethics Comm ittee on the completion of the study.
KLE
UNIV ERSITY
EIoI'OIoBlf(;~
KLE UNIVERSITY
[Established under Section 3ofthe UGCAct, 1956 vide MHRD, G.O.INotification No.F.9-19/2000-U.3(A) dt. 13111 April 2006)
Office of the Registrar , KLE University,
JNMC Campus, Nehru Nagar, Belgaum-590 010 , Karnataka State, India
II : 0831-2472777 FAX: 0831-2493777 Web: http://www.kleuniversity.edu.in
E-mail: [email protected]
Neither the PI nor any of the proposed study team members were present during the decision-making
procedures of the Ethics Committee.
Note: Phannacogenomic study in any form is not approved by the Ethics Committee.
Yours truly,
k: 4
(Dr. S. S.
dA\1-
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(Name & Signature of Ethics Committee
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