rnstitutional Ethies committee (rEc)

rnstitutionalEthiescommittee(rEc)
314/30,MirzaMandi,chowk,Lucknow_-2
pradesh,
26003,Uttar
phones;
0522_3239446;
FAX:OSZZ-+Oigi
Z
India.
E mail:[email protected]
To,
Date:12hJune2011
Dr.SandeepKumarGupta
M.V.Hospital& ResearchCentre
314130
MirzaMandi,Ghowk,
Lucknow-226003,
Ratz
l'ttr16loglrzlt
1
UttarPradesh,India.
'coo3 Reference:
A DoubleBlind,Randomized,
placebocontrolled,parallel
Group,Three
Arm Multicentre
and Muttinational
Pivotalstudy To Assess.The Efficacyand
safetyof Two
DcisageRegimensof crofelemerTablets
In The Treatmentof ModerateTo severe
Acute
WateryDiarrhea
ln Adultpatients."
sub: EthicscommifteeApprovalof study
Documentssubmittedon 31"t May2011.
DearSir,
This is to informyou that the submitted
documents
were reviewedand assessedby the
followingEthicscommitteemembers
on the day of the meeJingi.e. 12rhJune2011
at
10:00
A.M.
The meetingwas held in the officeof Ethics
committeeat M.V. Hospital& Research
centre,314130
Miza Mandi,cho,wk,Lucknow-226003,
Uttarpradesh,India.
. Meetingwasattendedby followingmembers:_
l.
2:
J.
4.
6.
.7.
MedicalProfessional/
Doctor/Chairperson
Scientist
Medical Professional/
Clinician
Pharmacologist
DTMMI(HAN
DR RITU GUPTA
DOCTOROF
MEDICINE
PRESENT
PHD.
PRESENT
DRVIJAYKUMAR
MS ORTHO.
PRESENT
DR SARVESH SINGH
MD IN
PHARMACOLOGY
PRESENT
LegalAdvisor
MR DIMSH KUMAR DIXIT
LLB
PRESENT
Scientist
DRARFEENNASIR
Ph-D.IN MEDICAL
BIOCHEMISTRY
PRESENT
SAIRA JAMEEL
PH.D
PRESENT
SHALINI GI.JPTA
B.A
PRESENT
DRRUCHIGHANDRA
Bsc MSc Phd
PRESENT
SocialWorker
8.
Lay Person
9
Basicmedical
scientisU
lVfember
Secretarv
PageI o/2
Theygavetheirapprovarto
thebelowmentioned
documents:1. Protocol
Version1.0datedApril10,2011
2, Investigator,s
Brochure
datedApril,10,2011
'
3' PatientInformation
sheetandInformed
consentFormVersion1.0datedApril10,2011.
4' PatientInformation
sheetandInformed
consentFormHindiLanguage
version1.0dated03
May 2011
5. CaseReportFormdated May2,2011
6. Investigato/sUndertaking
7. Investigator,s
CurriculumVitae
'8.
policy
Insurance
9. DCGIsubmissionLetter
The InstitutionalEthics committee for M.v. Hospital
& ResearchCentreexpectsto be
informedaboutthe:
1. Progress
of thestudy
2.Anyserious
AdverseEventsoccurring
duringthecourseof thestudy
3.Anychanges
in theprotocol& patientinformation
consent
4. Copyof thefinalreport
The lnstitutionar
Ethicscommitteefor M.V. Hospitar& ResearchCentreis
workingin
compliance
withrcMRGuiderines,
rcH Gcp Guiderines,
SchedUle
Y andapplicable
local
lauis.
Kindlyacknowledge
uswiththe receiptof thesame.
Regards
*r:::s#
i
;;;;;;#; si*$.*sti-..u'
$ii.$d'l
InstitutionalEthicsCEmmifteefor
M.V.Hospital& ResearchCentre,
314130
Mirzailandi, Chowk,
Lucknow-226003,
UttarPradesh,India.
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