INSTITUTIONAL ETHICS COMMITTEEKING GEORGE HOSPITAL

VISAKHAPATNAM· 530002 (A.P.)

To Date: 28/Au~/2()1tDr. Ramanand Satapathy,M.DBrain Mind Behaviour Neurosciences Research Institute,201, \iVV Chambers, Opp. King George Hospital,Maharani Peta , Visakhapatnam - 530002 ,Andhra Pradesh, India

Protocol 31-09-267: A Long-term. Multicenter. Open-Label Study to Evaluate the Safety andloJcrahility of I Icxible- Dose Oral Aripiprazole (OPC-14597) as Maintenance Treatment in\dokscent Patients with Schi/Ophrenia or Child and Adolescent Patients ",ith Bipolar IDisorder. Manic or Mixed Episode with or ",ithout Psychotic Features

Subject: Ethics Committee approval for the conduct of the referenced study at Brain MindHeha\iour Neurosciences Research Institute. 201, MVV Chamber~. Opp. K. G. Hospital,\Iaharani pela Visakhapatnam - : 30002. Andhra Pradesh. India and approval of the studyrdated documents.

Dear 1)1'. Ramanand Satapathy.

Pkase tind enclosed 15 copies (14 for EC and I for site) of following documents for submissionto your ethics committee and appro\ al during your forthcoming EC meeting:

• Protocol 310-09-267 Amend 3 Vel' 28 Mar 2011• Investigator's Brochure Edition 14, Released 09 Aug 2010• Investigator's Brochure Edition 14, Addendum version Idated 2~ ov 2010.• Investigator"s Brochurc Edition 14. Addendum version 2 dated 12 April 201 I.• I ngl"h Sitc Spccific Icr _Dr Ramanand Satapathy _Version 1.0.27 Jun 2011• Fnglish Site Specific Assent_Dr Ramanand Satapathy Version 1.0.27 Jun 2011• Iclugu Site Specific ICF Dr Ramanand Satapathy version 1.0 dated 05-Aug-20ll• I ranslation Certificate ofT ~IuguSite Specilic IeI' Dr Ramanand Satapathy version 1.0

datcd 05-Aug-2011• relugu Site Specific Assent Dr Ramanand Satapathy version 1.0 dated 05-Aug-20 II• I ranslation Ccrtificate ofTelugu Site Specific Assent Dr Ramanand Satapathy version

1.0 dated 05-Aug-20 I I

Patient ;\1aterial in En~lish• LS.\ f-NG 422 266-267 BRPA-OI V5-0 2010-07-02- - - --• 1S/\ ENG 422 266-267 APPD-OI vl-O 2010-05-27- - - -• 1 SA ENG 422 267 IOPD-OI v3-0 2010-06-01- - -• LSA LNG 422 266-267DN POPD-04 V3-0 2010-09-03- - - --• I'SA FNG 422 267 BRPD-O:L v4-0 2010-09-03- - - -

INSTITUTIONAL ETIDCS COMMITTEEKING GEORGE HOSPITAL

VISAKHAPATNAM • 530 002 (A.P.)• I SA F\lG 422 267 AMJACA-04_, 1-0 2011-01-13• I SA_ENG 422_267 AM_OPPA-03_v2-0_2011-01-17• ISA_ENG_ 422_266-267 _APPO-02_v 1-0_20 I0-05-27• IS\JNG_422_266-267_APPD-03_vl-0 2010-05-27• IS \JNG 422_266-267_APPO-04_vl-0_2010-05-27• P-QLES-Q• (ieneral Behavior Inventor:v(U13I)Parent/Guardian versionJVer 2.0-Eng-US-Oet 2010)• General Behavior Inventor. (UBI) for subject.• ADHR Rating Scales version IV (AOHO-RS-IV): Clinician Administered Version

Following documents in Telugu and Translation certificates for the same:

• INO TEL 422 267 APPO-OI vl-0 2010-05-27~ - - -• INO_TEL_ 422_267_lOPD-Ol_\3-0_201O-06-01• I D TEL 422 267 AM FACA-04 vl-O 2011-01-13- - - -• INO TEL 422 267 AM OPPA-03 v2-0 2011-01-17- - --• INO n:L 422 267 ON 1'01'0-04 v3-0 2010-09-03

- - - - -• INDIT.L 422 267 BRPO-02 v4-0 2010-09-03- - - -• IND TEL_422 267 DN_BRPA-02 v5-0_2010-07-02• NO TEL 422 266-267 APPO-02 ,1-0 2010-05-27- - - --• I. D_TEL_422_266-267_APPO-03_vl-0_2010-05-27• L 0 IEL 422 266-267 APPO-04 vl-O 2010-05-27

- - - - -

• Insurance Certificate• Investigator Undertaking• Investigator Brochure AOR of Addendum I & 2 -Icnclosed 2 copies - One signed copy

to be retained for your filing and one original to be sent on belo\\ said address]• "Iy current, signed and dated CV as a token or credentials for the conduct orthe stud) as

Principal Investigator.

.\t lhe fthies Committee meeting hcld on 20/Aug/201l your referenced letter and the abovedocuments \\ere examined and discussed. After considcration. the Committee has decided toapprmc thc aforementioned study-related documents as well as the study to be conducted under)our direction at Brain Mind Behaviour Neurosciences Research Institute, 201, MVVCham hers, 01'1'. K. G. Hospital, Maharani peta , Visakhapatnam - 530002 , AndhraPradesh, Tndia.

Please inrorm us, in case ifany serious adverse event is observed during the conduct of the slud)and also let us have a periodic report on the progress orthe study annually\\ e approve the assessments as specified in the clinical stud) protocol.

INSTITUTIONAL ETIDCS COMMITTEEKING GEORGE HOSPITAL

VISAKHAPATNAM . 530 002 (A.P.)

The members who attended this meeting held on 20/Aug/2011 at which your proposal wasdiscussed. are listed below: .

I Role InS.'\'o ame and Gender Qualification Ethics Affiliation lind contact

Committee number

~ i[)r.(i.SANTA RAOPRESIDENT Superintendent and

(\1) M.S Professor of Surgery. KingGeorge lIospital.

I Visakhapatnam-9848191 010 IRetired Professor and HODof Endocrinology.

Dr.K.DILEEP CHAIRMAN Consultant Endocrinology.') Kl MAR (M) M.D,D.M Visakha Diabetes And

Endocrine Centre.Visakhapatnam.9849116438Professor and Head of the

J)r.K.VISI fNU CO- department of euro, M.S. M.eh CHAIRMAN Surger) .King George.,PR \SAD (M) Hospital.r· Q849104287 ~

Associate Professor 0 f.j Dr M.Ri\JA GOPAL M.S SECRETARY Surgery,King George

(1\1) Hospital.9440319405Associate Professor of

5 Dr.P.VU'U GOPAL M.D. JOINT Paediatrics. King George(\'1) SECRETARY Hospital. Visakhapatnam.

I--- 9848027203Professor and Head of the

(,Dr.P.V.SUDHAKAR M.S.M.eh.DN CLINICIAN department of plastic(M) 13 surgery. Ki.ng George

Hospital.

INSTITUTIONAL ETIDCS COMMITTEEKING GEORGE HOSPITAL

VISAKHAPATNAM - 530 002 (A.P.)

Advocate, Visak hapatnam,

1"ri.R.UMA KUMAR LEGAL 9848294049

7 ';'''IRY B.Com,B.L EXPERT(\1 )

ON- Professor of Mechanical

Professor K.RAMJI 13.E.M.E. MEDICAL Engineering8 M.Tech, TECHNICAL AndhraUniversil). Visakhapa(M)

Ph.D tnam. 9440670584

SOCIAL Guru Nanak CharitableWORKER/ Trust, Visakhapatnam.SOCIAL 9848194808SClENTIST'REPRESENTATIVE orNON-

Mr.D.S.ANAND GOVERNAM9 B.E.MBA. LNTAL(M)

VOlJlJ":NTARYAGENCY/PHILOSOPHF.RETHICITS/THEOLOGIAN

Professor.of

BASIC Biochemistry.AndhraDr. KALPANA MEDICAL Medical

10 "l l3RAIJ\1A YAM M.D SCIENI IS r college, Visakhapatnam.(I 9848136731

IBASIC Pm'"w, of1'''h'''~JDr.13IIAGYA MEDICAL Andhra Medical11 I l.A KSHMI (F) M.D SCIENTIST College. Visakhapatnam

NON- Card iothoraeovascu larJ)r.P.Y.SATYANAR M.S, M.ch GOVF.RNML Surgeon.Care Hospital,12 \ Y \. A (M) NT DOCTOR Visakhapatnam.

I

INSTITUTIONAL ETHICS COMMITTEEKING GEORGE HOSPITAL

VISAKHAPATNAM - 530002 (A.P.)

~

--- ------

Dr.K.ANANDA RAOM.D(\1 )

r-

Prolessor

14 I .K.MOHAN RAO M.A. Ph.D("I)

MEMBER

SOCIALSCIFNCESAND LAYPERSON

Associate Professor ofDermatology. King GeorgeI Iospital. Visakhapatnam.9848197681Professor of Economics.AndhraIJniversil), Visakhapatnam.

9848227754.

MEMBER15 Dr.G.VENKAn:SWA M.D ..D.MR'\ REDDY (M)

-~I------ ~-----lProfessor of Cardiolog)King GeorgeHospital. Visakhapatnam.

____________19849129394

It is to he noted that neither you nor any of your proposed study team members were presentdunng the declslOn-makll1g procedures of the Ethics Committee.

Yours truly.

I\amc: DroKoDileep Kumar,MoD,DoM Si~naturc:

Title: Chairperson Date: ---------