AMRITA

W
AMRITA
VISHWAVIDYAPEETHAM
Healthcare, Education & Research
Date: 20-11.-2A08
The Institutional Ethics Committee meeting was held on 15-1L-2008in Maithri
Mandir with Sfi. K. Srikumar as chairPerson.
Members attended the meeting:
Adv. Srikumar K
Dr. Shanti Nair
Dr. D. M. Vasudevan
Dr. Prabha Rao B
Sri SaseendranK
Dr. Prathapan Nair
Mrs. Anjana Balakrishnan
Sri Krishna Swamv N
The Committee reviewed the following documents pertaining to new protocol
u
No.EGF110656 titled A Phase III Study of Erbb2 Positive Advanced Or
Gastroesophageal ]unction
Esophageal Or
Metastatic Gastric Or
With Or Without
Plus
Oxaliplatin
Adenocarcinoma Treated With Capecitabine
Lapatinib" submitted by Dr. T. S. Ganesan as principal investigator in the
Institutional Ethics Committee meeting held on 25-10-2008:
1..
2.
3.
4.
5.
.
6.
Executive Summary of EGF110656/TRIO-CIRG 013(LOGiC)
Study Protocol EGF110656,Amendment# L, Dated -5 May 2008
Investigator Brochure Versions # 8, Dated - 11 April2008
EGF 110656- CRF Screenshots,Version 1.0,Final Dated - 2 May 2008
Patient Information and Consent Form, Version # 01.01,Dated -2 ]une 2008
- English (col /8GF770656- TRIO CIRG }L}/ICF/ENG /Version 01.01)
- Malayalam (col /EGF110656- TRIO CIRG 013/ICF/ MAL /Version
01.01)
Back translation:
- Malayalam (COI /EGF110656- TRIO CIRG 013/ICF/MAL /Version
01.01)
Health Related Questionnaire For Patients:-
EQ-sD
r.
a. English
b. Malayalam
u.
ru.
IV.
EORTCQLQ-STO22- English
- English
EORTCQLQ-OES18
EORCTCQLQ-C30
l"--q'
l.. ' fg' fg6sr-rA RAo
AMRITAPUR,I
.
BANGALo)RE
<}
c:c'IMBATORE
<}
KOCHI
a. English
b. Malayalam
7.
LOGiC
o Letter for Image Acquisition Guidelines
o Lesion synchronization: Marked Images Guiderines
o Image Acquisition Guidelines, perceptive Informatics, Inc.
o " Investigator Site eualification_FAe
8.
SubjectEmergency Un-blinding Card in
a. English
b. Malayalam
9. Clinical Trial Compensation Guidelines (ABpI)
10. Copy of Insurancecertificate.
11. PGx Booklet (PharmacogeneticsSample management)
a. English
b. Malavalam
12. CV of Dr T S 6ur"run
13. DCGI Approval letter, dated 10 Oct 08
'1,4.
Draft copy of CTA and Budget
15. Import License
The Committee recommended the following:
Scientifically there are no major concerns about the design or methodology of
this project. The rationale of including esophagealcancer with gastro-esophigeal
tumors needs to be clarified. Specific details of the pharmaco-genomic aspect of
the study are not given.
A fresh approval certificate from the Drugs Controller general has to be
produced before the committee since the piotocol number in the evidenced
document is different.
Since the blood and tumor samples are sent abroad, the required permission
from the authority concernedis required.
A declaration from the PI assuring non-involvement in the genetic sfudy needs
to be submitted before the committee.
The Insurance amount may be increasedto 25 lakh per patient and 5 crores in a
year.
In Clinical trial agreement Page L, delete "Dept of Medical oncology of,, to read
it as "Amrita Institute of Medical sciences & Research Centre,'- and make it
tripartite between Institution, pI and the Sponsor.
\
t,r..'.@....1uthenticated.Y.'...'.''''.ffi.
) .. - g' PAoBrl p lt*a
(Membersof IEC)
In Clause 6.1.,6.2 and appendix 4 (Clause 1) in CTA, include PI, Co-PIs, IEC
members also.
In the Ethics Committee meeting held on 15-11-2008,the principal investigator
clarified the points with supporting documentsvide letter dated 15 Nov. 2008.
After reviewing the same, the committee approved the protocol with a
reconunendation to submit a copy of Export License to IEC before exporting
samples abroad. It is to be noted that this site is not involving in any genetic
studv.
It is mandatory that Principal Investigator should submit a Periodic Report
during the progress of the study and a Final detailed Report on closure of the
study.
It is to be noted that neither the Principal Investigator nor any of his proposed
study team member was present during the decision-making procedures of the
Ethics Committee.
It is the policy of the Ethics Committee to be informed of any serious adverse
events occurring during the course of study. This approval is for the entire
duration of the study.
K.
To
CHAIRMAN
Institutional Ethics Committee
AmritaInstituteof MedicalSciencet
& Research
Centre,
Elamakkara
PO Kochr
682026,Kerala.
lndia
Tel914844001
234Ext 6142,914844006142
Fax:914844002020,
914842802124
Dr. T. S. Ganesan,
PI, ProtocolNo. EGF110656
Authenticated bv:
a
\ - , P . ? r f O . r l wi(b{
J <
(Membersof IEC)