National Ethics Gommittee

NationalEthicsGommittee
Opp.Sul'idhaShoppingCentre,Paldi,Ahmedabad- 380 007
Apartments,
A/g01,Chandanbala
65i125262
Phone : 079 ' 265EE115,
CHAIRMAN:
Dr. G. R. Bhagat
+
SECRETARY
MEMBER
Mrs. RupalG.
*
@[9: 13ftApril,2009
$[-: NEC90401
To,
Dr. Pradip VaghasiYa
(GIPS)'
GujaratInstituteof PsychologicalScienceandResearch
Road'
Vijay
Complex(SatelliteHospital);Umiya
Shieenath
OppositePunitNagar-l,Satellite'
80015. India
Ahmedabad-3
MEMBERS:
Label Extension study of the
s[: Protocol No. : RGH-MD-17 A long te'rm, open
Patients with Schizophrenia.
(Cariprazine)
in
of
RGH-L88
Tolerability
and
S"f"tV
Dr. PuruiShah
(M.S.,
D.O.)
+
GireeshchandraR.
(8. Pharm.)
+
Dr. Shetal Shah
(M.D.,DCP)
and the conduct of
$$, Ethics committee approval of study-related documents
the above mentioned studY.
Dear Dr. Vaghasiya,
Your letter dated Il [Marl2009
We havereceivedfrom you 09 copiesof the following study documents:.
1.
Final Protocol RGH-MD-171 dateJanualy 20,2009:-ControlledCopy QR/279|RGHMD- 17/January 20,2009I 127-135 .
+
2.
Investigator's Brochure RGH-MD-17/. date February 02,2A09:-ControlledCopy
QR/279[RGH-MD- I TlFebruary 02,2009/ 121 135.
Dr. JigneshP. SHah
r(M.S.)
3.
India Specific Informed Consent Form Version 2.O,datedl8 Feb 2009/Dr.Pradip
Bhikhalal Vaghasiya
4.
India Specific Caregiver Consent Form Version 2.O,dated18 Feb 2009/Dr.Pradip
Bhikhalal Vaghasiya
5.
SubjectSafetyCard,Version1.0, dated02 Feb 2009.
*
Dr. RajnikantThakore
(G.F.A.M.,
L.M.P.)
+
Advocate H, C. Patel
(B.Com.,
LLB)
+
Mansi Joshi
(SocialWorker)
Page I of 3
NationalEthicsGommittee
A/301,ChandanbalaApartments,Opp.Suv'idhaShoppingCentre,Paldi,Ahrnedabad 380 007
Phone : 079 - 265E6115, 65i125262
CHAIRMAN:
Dr.G.R.Bhagat
*
6.
SECRETARY
MEMBER
Mrs.RupalG.
+
MEMBERS:
Dr. Purvi Shah
(M.S.,
D.O.)
*
GireeshchandraR.
(8. Pharm,)
*
Dr. ShetalShah
(M.D.,DCP)
PsychiatricScales
a. Clinical Global Impressions(CGI-S) , dated 26Jan2O09'
b . BarnesAkathisia Scale(BARNES), dated26 Jan2009
a
SimpsonAngus Scale(SAS), dated26Jan 2009
d . AlMS-Examination Procedure, dated 26Jan 2009' (STS),Copyright SheehanDV' 2005-2009
e . SuiciAatltyTracking Scale (STS) , dated26lan2OO9
f. StructuredClinical Interview- Positive and Negative Syndrome
Scale { SCl -PANSS) dated26 Jan 2009
We have also receivedfrom you the following documents(1 copy each)'
r
Investigators' undertaking
o Your current signed and dated CV
r
List of study team members
ll'h
April,2009,at Aon
Ethics Committee meeting held
the
At
30l,Chandanbala,Paldi,Ahmedabad380007,)rour referenced letter and the above
documents were examined and discussed. Alter due consideration, the Committee has
decided to approve the aforementionedstudy-relateddocuments as well as the study to be
conductedund"r you. direction at your Centre,GujaratInstituteofPsychological Sciences
Research centre(GlPS),shreenath complex(Satelite Hospital),Umiyavijay
&
.Plear;enote that the Ethics Committee approval
Road,satelite,Ahmedabad-380015,India.
for the study is subject to DCGI approval and kindly send us the Insurance Certificate for
the study prticipants..
The Ethics Committee approval is for a period of tvvoyears.
We understand that a Central Laboratory lvill be used in the study and the Ethics
Committeehas no objectionfor the samplesto be shippedoutsideIndia.
*
Dr. JigneshP. SHah
(M.s.)
The Ethics Committee expects to be informe<l about the progress of the study, any SAE
occuring in the course of the study, any change in the protocol and patient
information/informed consent and also let us hLavea periodic report on the progressof the
studv annuallv.
+
Dr. RajnikantThakore
(G.F.A.M.,
L.M.P.)
as specifiedin the protocol.
We approvethe assessment
+
Advocate H. C. Patel
(B.Com.,LLB)
*
Mansi Joshi
(SocialWorker)
Page2 of 3
NationalEthicsGommittee -
Centre,Paldi,Ahrnedabad380007
Opp.SuvidhaShopping
Apartments,
fu301,Chandanbala
15, 65i125262
Phone : 079 - 265EE1
CHAIRMAN:
Dr. G. R. Bhagat
*
at whichyour proposal
The memberswho attendedthemeetingheld orrApril 11,2009
Wasdiscusedareasfollows :
:
SECRETARY
MEMBER
Mrs. RupalG.
Name
Dr. G. R. Bhagat
*
Mrs. Rupal G.
Mei{rinst
Dr. Purvi Shah
Position In NEC
M.D.(Mtedicine)
Rtd.Prot'B.J.Med'College,A'hd/Hon'Physicianat
Dr'Jivraj Mehta smarakHealth Foundation
Member SecretarY B.A.
Human ResourceDevelopment Officer
M.S.'D.O.
Member
GireeshchandraR.
Dr. PuruiShah
(M.S.,
D.O.)
+
GireeshchandraR.
(8, Pharm.)
*
Dr. Shetal Shah
( M . D ,D
, CP)
+
Dr.ligneshP. SHah
(M.s.)
*
Oualification & Affiliation
Chairman
Member
Dr. Shetal Shah
Member
Dr. JigneshP. Shah
Member
Dr.Rajnikant Thakore Member
Mr.H.C.Patel
Member
Smt. Mansi Joshi
Member
SaurabhJoshi
Member
& J Instituteof
Asstt.Professor,Ophthalmology,M
Campus,Ahmedabad.
Hospital
Ophth.,Civil
B.Phann
arat
Commissioner'Gui
Retd.Drug
M,D.,D.C.P.
PractisingPathologist
M.S.
PractisingSurgeon
G.F.A.M.,L.M.P.
FamilyPhYsician
Practising
B.Com.,LLB
Advocate,IncomeTax Practitioner
B.Com
SocialWorker
Lay Pr:rson
It is to be noted that neither you nor any of your proposed study team members were
presentduring the decision-making proceduresof the Ethics Committee.
Your's truly,
P'6AtA^'l.Onatorn
lb-04-Ue1
(Dr. Gautam R. Bhagat)
Chairman.NEC
Dr. RajnikantThakore
(c.F.A.M.,
L.M.P,)
+
Advocate H. C. Patel
(B,Com.,LLB)
+
Mansi Joshi
(SocialWorker)
Page3 of 3