Fax: 079-26585741 Paldi, Ahmedabad 380 006. ETHICSCOMMITTEE Tel. : 079-26586152/7152 Fax:...

INDEPENDENT ETHICS COMMITTEETel. : 079-26586152 J 7152Fax: 079-26585741E-mail: [email protected]

57, Brahmin Mitra Mandai Society,BIW Paldi Bus Stop & Jalaram Mandir,

Paldi, Ahmedabad 380 006.

Dr. Preeti Mehta Mr. Niranjan Bhagat Mr. Guarang Shelat

Members:I. Dr. Shashank Desai2. Dr. Himanshu Shah3. Dr Bhasker Vyas4. Dr. Paresh Shah5. Mr. Tapesh Maheshwari6. Mrs. Ushaben Pathak7 Mr. Deepak Kolsawala8. Mr. Nishith Mehta

!Deputy Chairman Chairman Member Secretary

Date: 22/FEB/2012Ref.: IEC/02-12J02To,Dr. Vaishal N. VoraSNEH Clinic301-2-3, Nakshatra Complex,Canara Bank Road, Maninagar.Ahmedabad-380008.

Reference: Roche R04917838 Protocol NO.NN25310vC: This is a Phase III, multi-center,randomized, 24 week, double-blind, parallel-group, placebo-controlled study to evaluate efficacy andsafety ofR04917838 in stable patients with persistent, predominant negative symptoms of schizophreniatreated with anti psychotics followed by a 28 week, double-blind treatment period.

Subject: Ethics Committee approval of study-related documents and conduct of the above mentionedstudy at Sneh Clinic, Ahmedabad.

Dear Vaishal Vora,

This is further to the letter dated 13-Feb-2012 via which we have received 11 copies of each of the belowmentioned study documents.

Study documents:

1. Protocol/Roche _ NN25310vC (R04917838) dated 21-Apr-20 11

2. Investigator Brochure_ Version 10 dated November 2011

3. Main Patient Informed Consent Forms:

a. English India Main Patient Informed Consent Form version V01.IND02. 241747vOIdated 20 Jan 2012

b. Hindi Hindi Main Patient Informed Consent Form Version V01.IND02.241747vOIdated 20 Jan 2012

c. Gujarati Gujarati Main Patient Informed Consent Form Version VOl.IND02.241747vOIdated 20 Jan 2012

4. Main Caregiver Informed Consent Forms:

a. English India Main Caregiver Informed Consent Form version VOl.IND01.241747vOldated 14 Dec 2011

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INDEPENDENT ETHICS COMMITTEETel. : 079-26586152/7152Fax: 079-26585741E-mail: [email protected]



:Ylembers:J. Dr. Shashank Desai2. Dr. Himanshu Shah3. Dr Bhasker Vyas4. Dr. Paresh Shah5. Me Tapesh Maheshwari6. IV1rs.Ushaben Pathak7. Mr. Deepak Koisawaia8. Mr. Nishith Mehta


Deputy Chairman Chairman Member Secretao'

b. Hindi Hindi Main Caregiver Informed Consent Form Version VOl.IND01.241747vOldated 14 Dee 2011

e. Gujarati Gujarati Main Caregiver Informed Consent Form Version VOl.IND01.241747vO1dated 14 Dee 2011

5. Long Term Extension Patient Informed Consent Forms:

a. English India Long Term Extension Patient Informed Consent Form version VOUND02.241747vOl dated 20 Jan 2012

b. Hindi Hindi Long Term Extension Patient Informed Consent Form VersionVOI.TND02.241747vOl dated 20 Jan 2012

. -.e. Gujarati Gujarati Long Term Extension Patient Informed Consent Form Version

VOl.IND02.241747vOl dated 20 Jan 2012

6. Long Term Extension Caregiver Informed Consent Forms:

la English India Long Term Extension Caregiver Informed Consent Form versionVOl.IND01.241747vOI dated 14 Dee 2011,

b. Hindi Hindi Long Term Extension Caregiver Informed Consent Form VersionVOI.lND01.241747vOI dated 14 Dee 2011 --

e. Gujarati Gujarati Long Term Extension Caregiver Informed Consent Form VersionVOl.lND01.241747vOI dated 14 Dee 2011

7. Patient ID Cards along witb Translation certificates:

a. English SearehLyte Program (Negative Symptoms), Patient ID Card, Version 2.0 dated 11August 2010Y02.USA(EN).01

b. Hindi SearchLyte Program (Negative Symptoms), Patient ID Card, Version 2.0 dated IIAugust 2010Translated from English to Hindi on 09 Sep 2011 by Ajay PandeyYOl.lND.O 1

e. Gujarati SearchLyte Program (Negative Symptoms), Patient ID Card, Version 2.0 dated 11August 2010Translated from English to Gujarati on 09 Sep 2011 by Shyam JaniYOl.IND.Ol

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Tel. : 079-26586152/7152Fax: 079-26585741E-mail: [email protected]

INDEPENDENT ETHICS COMMITTEE57, Brahmin Mitra Mandai Society,

B/W Paldi Bus Stop & Jalaram Mandir,Paldi, Ahmedabad 380 006.

Members:I. Dr. Shashank Desai2. Dr. Himanshu Shah3 Dr Bhasker Vyas4. Dr. Paresh Shah5. Mr. Tapesh Maheshwari6. Mrs. Ushaben Pathak7. Mr. Deepak Kolsawala8. Mr. Nishith Mehta


Deputy Chairman Chairman Member Secretary

8. Clinician rated Scales(In English)

1. Guidance document for Guidance document for medical resource use (MRU) questions,medical resource use (MRU) 26 July 2010questions

2. Guidance document for Guidance document for questionnaire how to characterizequestionnaire how to patient population, 07 Oct 2010characterize patient population

3. ROC005_GlyT 1 Phase ROC005 GlyT 1 Phase III WoRQ SOURCE FINAL 2011 Jul 20- - - - --lll_ WoRQ Source

4. ETDRS Chart Worksheet EW (201.1) 10119/20075. Structured Interview For The Structured Interview For The Personal And Social Performance Scale.

Personal And Social Clinician VersionPerformance Scale (SIPSP)

6. ROC005_GlyT I Phase III_PSP SOURCE_FINAL_2010_0ct_l \.PSP - Worksheet

7. ROC005_GlyT 1 Phase IJI_SCID-CT Source_Final_2010_0ct_15.SCID-CT for Schizophrenia SCID-CT for Roche (July 2010)

8. Extrapyramidal Symptom ROC005_GlyT I Phase III_ESRS-A ManualRating Scale-Ab breviated Source Final 2010 Jul 27- - --(ESRS-A) February 28, 2006Instruction Manual

9. Extrapyramidal Symptom ROC005_GlyT 1 Phase III_ESRS-A Long FormRating Scale-Abbreviated Source Final 20 10 Oct 11. February 28, 2006

10. CGI-SCH ROC005_GlyT 1 Phase ITCCGI-SCH User's GuideClinical Global Impression Source_2010_Sep_21Scale

11. ROC005_GlyT 1 Phase lII_CGI-PS-SI Source]inal_2010_0ct_11.Clinical Global Impression - ROC005_GlyT I Phase III_CGI-PS-SI

Positive and Overall SOURCE FINAL 2010 Oct 11.- - - -Symptoms

12. ROC005_GlyT 1 Phase IICCGI-NS-SI Source_Final_2010_0ct_1 1.Clinical Global Impression - ROC005_GlyT 1 Phase IlI_CGI-NS-SI

Negative and Overall SOURCE]INAL_2010_0ct_11Symptoms

13. Negative Symptom ROC005 _GlyT 1 Phase III_NSA-16 ManualAssessment-16 (NSA-16) Source Final 2010 Jul 27.- - --Instruction Manual

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•INDEPENDENT ETHICS COMMITTEETel. : 079-26586152/7152Fax: 079-26585741E-mail: [email protected]

57, Brahmin Mitra Mandai Society,B/W Paldi Bus Stop & Jalaram Mandir,


Members:I Dr. Shashank Desai2. Dr. Himanshu Shah3. Dr Bhasker Vyas4. Dr. Paresh Shah5. 1'.1r.Tapesh Maheshwari6. Mrs. Ushaben Pathak7. Mr. Deepak Kolsawala8. Mr. Nishith Mehta



SEMI-structured interview forrating the NSA-16

ROC005_GlyT I Phase IJI_NSA-16 Interview Guide Source_Final2010 Oct 11.- - -

14.

Negative SymptomAssessment-16 (NSA-16)

ROC005_GlyT 1 Phase III_NSA-16 Anchors Source_Final2010 Oct 11.

- - -February 28, 2006

15.

16. Calgary Depression Scale forSchizophrenia (CDSS)PANSS QuikScoreTM Form ROC005_GlyT 1 Phase III_PANSS QuikScore Source_Final

2010 Oct 11.- - -

17.

PANSS Positive and NegativeSyndrome Scale

18. ROC005_GlyT I Phase III_PANSS Anchors Source Final_2010_Aug_23

19. IQ-PANSS Positive andNegative Syndrome ScaleSCI-PANSS20.

9. Patient scales (PROs)

a. EQ-SD with Validated Certificate

English: 1998 EuroQol Group EQ-5DTMis a trade mark of the EuroQol GroupHindi 2008 EuroQol Group. EQ-5DTMis a trade mark of the EuroQol GroupGujarati 2006 EuroQol Group. EQ-5DTMis a trade mark of the EuroQol Group

b. ZBI with validation certificate

English ROC005 GlyT 1 Phase III ZBI Source Final 2010 Oct 11.Hindi ROC005_GlyT J Phase III_ZBT_Hindi - India_2011_Sep_02.doc ZBT-

IndialHindi - 14 Apr 08 - Mapi Research Institute. 1045471 ZBI-22 AU1.0 hin-IN

Gujarati ROC005_GlyT 1 Phase III_ZBI_Gujarati_2011_0ct_06.doc ZBI-22-IndialGujarati - Version of 03 Oct 11 - Mapi Institute. ID6408 / ZBI-22 TS2.0 guj-IN

c. C-SSRS Baseline

English C-SSRS Baseline Version 1114/09Hindi C-SSRS - Baseline - India/Hindi - Version of 12 Mar 10 - Mapi Research

Institute.ID5353 1C-SSRS-8aseline AU3.0 hin-IN.

Gujarati C-SSRS-8aseJine - IndialGujarati - Version ofFeb 10 - Mapi ResearchInstitute.JD5353 / C-SSRS-8aseline AU3.0 guj-IN.

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Members:1. Dr. Shashank Desai2. Dr. Himanshu Shah3. Dr Bhasker Vyas4. Dr. Paresh Shah5. Mr. Tapesh Maheshwari6. Mrs. Ushaben Pathak7. Mr. Deepak Kolsawala8. Mr. Nishith Mehta


Deputv Chairman Chairman Member Secretary

d. C-SSRS Since Last VisitEnglish C-SSRS Since Last Visit Version 1114/09Hindi C-SSRS - Since Last Visit - India/Hindi - Version of 12 Mar 10 - Mapi

Research Institute.ID5353 1C-SSRS-SinceLastVisit AU3.0 hin-IN

Gujarati C-SSRS-Since Last Visit - IndialGujarati - Version ofFeb 10 - MapiResearch Institute.ID5353 1 C-SSRS- SinceLastVisit AU3.0 guj-IN

e. Informed Consent Guide with validation certificateEnglish Informed Consent Guide V03.IND(EN).01Hindi SearchLyte Program (Negative Symptoms)

Informed Consent GuideVersion 3.0, dated 10 September 2010Translated from English to Hindi on 30 September 2011 by OxfordConversis Ltd.[V03.IND(HI).01 ]

Gujarati SearchLyte Program (Negative Symptoms)Informed Consent GuideVersion 3.0, dated 10 September 2010Translated from English to Gujarati on 30 September 2011 by OxfordConversis Ltd.[V03.lND(GU).0 1]

f. Milestone Certificates with validation certificate

-- English Milestone Certificates V02.IND(EN).01Hindi SearchLyte Program (Negative Symptoms)

Milestone CertificatesVersion 2.0, dated 19 August 2010Translated from English to Hindi on 30 September 2011 by OxfordConversis Ltd.[V02.IND(HI).01]

Gujarati SearchLyte Program (Negative Symptoms)Milestone CertificatesVersion 2.0, dated 19 August 2010Translated from English to Gujarati on 30 September 2011 by OxfordConversis Ltd.[V02.IND(GU).01]

g. Patient Brochure with validation certificateEnglish Patient Brochure V03.IND(EN).01Hindi SearchLyte Program (Negative Symptoms)

Patient BrochureVersion 3.0, dated 10 September 2010Translated from English to Hindi on 30 September 2011 by OxfordConversis Ltd.[V03.IND(HI).OJ]

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Deputy Chairman Chairman Member SecretaryMembers:I. Dr. Shashank Desai2. Dr. Himanshu Shah3 Dr Bhasker Vyas4 Dr. Paresh Shah5. Mr. Tapesh Maheshwari6. Mrs. Ushaben Pathak7 Mr. Deepak Kolsawala8. Mr. Nishith Mehta


Gujarati SearchLyte Program (Negative Symptoms)Patient BrochureVersion 3.0, dated 10 September 2010Translated from English to Gujarati on 30 September 2011 by OxfordConversis Ltd.[V03.IND(GU).01]

h. Doctor-to-Patient Letter with validation certificateEnglish SearchLyte Program (Negative Symptoms), Doctor-to-Patient Letter,

Version 3.0 dated 10 September 2010V03.IND(EN).01

Hindi SearchLyte Program (Negative Symptoms)Doctor-to-Patient LetterVersion 3.0, dated 10 September 2010Translated from English to Hindi on 30 September 2011 by OxfordConversis Ltd.[V03.IND(HI).01]

Gujarati SearchLyte Program (Negative Symptoms)Doctor-to-Patient LetterVersion 3.0, dated 10 September 2010Translated from English to Gujarati on 30 September 2011 by OxfordConversis Ltd.[V03.IND(GU).0 I]

i. Caregiver Animation with validation certificateEnglish SearchLyte Program (Negative Symptoms). Caregiver Responsibilities,

Version 2.0 dated 5 August 2010Caregiver Animation [V02.IND(EN).0 1]

Hindi SearchLyte Program (Negative Symptoms), Caregiver Animation,Version 2.0, dated 20 August 2010Translated from English to Hindi on 30 September 2011 by OxfordConversis Ltd.,[V02.IND(HI).01]

Gujarati SearchLyte Program (Negative Symptoms), Caregiver Animation,Version 2.0, dated 20 August 2010Translated from English to Gujarati on 30 September 2011 by OxfordConversis Ltd.,[V02.IND(GU).0 1]

.i. MCCB Scale

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Deputy Chairman Chairman Member SecretaryMembers:1. Dr. Shashank Desai2. Dr. Himanshu Shah3. Dr Bhasker Vyas4. Dr Paresh Shah5. Mr. Tapesh Maheshwari6. Mrs. Ushaben Pathak7. Mr Deepak Koisawaia8. Mr. Nishith Mehta


English_MCCB • MCCB HVLTR-

• MCCB AdminFm-

• MCCB _Respondents_Booklets

Hindi MCCB • MCCB Hindi HVLTR fm1 Submission- - - -• MCCB Hindi AdminFm A Submission- - - -• MCCB Hindi Respondents Booklet A Submission

We have received I copy each of the following documents for notification:

I. e-CRF NN253 I0 Version 1.0 - Generated On: 03 Nov 2010 17:03:23

2. Investigator's Undertaking (per the revised schedule Y of Drugs and Cosmetics Rules, 1945)

3. Curriculum Vitae as token of credential for the conduct of the study of the PI

4. List ofteam members.

At the Ethics Committee meeting held on 17/F eb12012 your referenced letter and the above documentswere examined and discussed. After due consideration, the committee has decided to approve theconduct of the aforementioned study under your direction at Sneh Clinic, Ahmedabad as well as all thestudy related documents.

The Ethics Committee expects to be informed about the progress of the study, any SAE occurring in thecourse of the study, any change in the protocol and patient information! informed consent and also let ushave a periodic report on the progress of the study annually.

We approve the assessment as specified in the protocol.

The following members of the Independent Ethics Committee were present at the meeting held on17/FEB/20 12, Mehta Hospital, Paldi, Ahmedabad, India.

Sr. No. Name Role in Ethics Committee Sex1. Mr. Niranjan Bhagat Chairman- Male

Lay person from the community2. Mr. Gaurang She/at Member Secretary Male

3. Dr. Shashank Desai Clinician Male

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INDEPENDENT ETHICS COMMITTEETel.: 079-26586152/7152Fax: 079-26585741E-mail: [email protected]

57, Brahmin Mitra MandaI Society,B/W Paldi Bus Stop & Jalaram Mandir,


Members:I. Dr. Shashank Desai2. Dr. Himanshu Shah3. Dr Bhasker Vyas4. Dr. Paresh Shah5. Mr. Tapesh Maheshwari6. Mrs. Ushaben Pathak7. Mr. Deepak Koisawaia8. Mr. Nishith Mehta



4. Dr. Bhasker Vyas Basic medical scientists Male

5. Dr. Himanshu Shah Clinician Male

6. Mrs. Ushaben Pathak Legal expert Female

7. Mr. Deepak Kolsawala Social scientist Male

8. Mr. Tapesh Maheshwari Pharmacologist Male

9. Mr. Nishith Mehta Social scientist Male

It is to be noted that neither you nor any of your proposed study team members were present during thedecision-making procedures of the Ethics Committee.

The Ethics Committee works as per the guidelines of ICH-GCP, Schedule Y and all applicable localregulatory requirements.

Yours .: . " . ,,/X~ ""-~(Jy~~vMr. NiranX;;:~agatChairmanIndependent Ethics Committee57, Brahmin Mitra Mandai Society,B/W Paldi Bus Stop & Jalaram Mandir,Paldi, Ahmedabad -380006,India

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