independent ethics committee - clinical trials registry · extrapyramidal symptom roc005_glyt i...

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

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

Paldi, Ahmedabad 380 006.

Members:I . Dr. Shashank Desa i2. Dr. Himanshu Shah3. Dr Bhasker Vyas4. Dr. Paresh Shah5. !VIr.Tapesh Maheshwari6. Mrs. Ushaben Pathak7. Mr. Deepak Kolsawala8. Mr. Nishith Mehta

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

Deputy Chairman Chairman Member Secretary

Date: 22/FEB/2012Ref.: IEC/02-12/03To,Dr. Vaishal N. VoraSNEHClinic301-2-3, Nakshatra Complex,Canara Bank Road, Maninagar.Ahmedabad-380008.

Reference: Roche R04917838 Protocol No. NN25307C: Phase 1Il, multicenter, randomized, 12 week,double blind, parallel group, placebo controlled study to evaluate efficacy and safety of R04917838 instable patients with sub optimally controlled symptoms of Schizophrenia treated with antipsychoticsfollowed by a 40 weeks, 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-20 12 via which we have received 11 copies of each of the belowmentioned study documents.

Study documents:

1. Protocol/Roche _NN25307C (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 VOl.IND02.241791 vOl dated20 Jan 2012

b. Hindi Hindi Main Patient Informed Consent Form Version VOl.IND02.241791 vOl dated20 Jan 2012

c. Gujarati Gujarati Main Patient Informed Consent Form Version VOI.IND02.241791 vOldated 20 Jan 2012

4. Main Caregiver Informed Consent Forms:

English India Main Caregiver Informed Consent Form version VOl.IND01.241791vOIdated 14 Dee 2011

40G~J-A~{/fi Page I of8

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

57, Brahmin Mitra Mandai Society,8/W Paldi Bus Stop & Jalaram Mandir,


Members: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



b. Hindi Hindi Main Caregiver Informed Consent Form Version V01.IND01.241791 vOldated 14 Dec 201 I

c. Gujarati Gujarati Main Caregiver Informed Consent Form Version VOl.IND01.241791 vOldated 14 Dee 2011

5. Long Term Extension Patient Informed Consent Forms:

a. English India Long Term Extension Patient Informed Consent Form versionV01.IND02.241791vOl dated 20 Jan 2012

b. Hindi Hindi Long Term Extension Patient Informed Consent FOITnversionYOl.IND02.241791 vOl dated 20 Jan 2012 -

c. Gujarati Gujarati Long Term Extension Patient Informed Consent Form VersionV01.IND02.241791 vOl dated 20 Jan 2012

6. Long Term Extension Caregiver Informed Consent Forms:

a. English India Long Term Extension Caregiver Informed Consent Form versionY01.IND01.241791vOl dated 14 Dec2011

b. Hindi Hindi Long Term Extension Caregiver Informed Consent Form VersionY01.IND01.241791vOI dated 14 Dec 2011

c. Gujarati Gujarati Long Term Extension Caregiver Informed Consent Form VersionVOl.lND01.24179IvOI dated 14Dec2011

7. Patient ID Cards along with Translation certificates:

a. English SearchLyte Program (Sub-optimally Controlled Symptoms), Patient ID Card,Versionl.O dated 22 October 2010VOl.USA(EN).O1

b. Hindi SearchLyte Program (Sub-optimally Controlled Symptoms), Patient ID Card,Versionl.O dated 22 October 2010Translated from English to Hindi on 09 Sep 20 II by Ajay PandeyVOl.IND.Ol

c. Gujarati SearchLyte Program (Sub-optimally Controlled Symptoms), Patient ID Card,Versionl.O dated 22 October 2010Translated from English to Gujarati on 09 Sep 2011 by Shyam JaniVOl.IND.Ol

8. Clinician rated Scales(In English)

1. Guidance document formedical resource use (MRU)questions

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


57, Brahmin Mitra Mandai Society,8/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 Kolsawala8. Mr. Nishith Mehta



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

3. ROC005_GlyT 1 Phase ROC005_GlyT 1 Phase IlC WoRQ SOURCE_FINAL_2011_Jul_20III WoRQ Source

4. ETDRS Chart Worksheet EW (201.1) 10/19/20075. Structured Interview For The Structured Interview For The Personal And Social Performance Scale.

Personal And Social Clinician VersionPerformance Scale (SIPSP)

6. PSP - Worksheet ROC005 GlyT 1 Phase III PSP SOURCE FINAL 2010 Oct 11.7. SCID-CT for Schizophrenia ROC005 _GlyT 1 Phase III_SCIO-CT Source_Final_ 2010_ Oct! 5.

SCID-CT for Roche (July 2010)8. Extrapyramidal Symptom ROC005_GlyT I Phase III_ESRS-A Manual

Rating Scale-Abbreviated Source Final 20 I0 Jul 27- - --(ESRS-A) February 28,2006Instruction Manual

9. Extrapyramidal Symptom ROC005_GlyT I Phase III_ESRS-A Long FormRating Scale-Abbreviated Source Final 2010 Oct 11. February 28, 2006.

10. CGJ-SCH ROC005_GlyT I Phase III_CGI-SCH User's GuideClinical global impression Sourcc_201 0_Sep_21 .scale

II. Clinical Global Impression- ROC005_GlyT 1 Phase III_CGI-PS-SJ Source_Final_2010_0ct_11.Positive and Overall ROC005_GlyT I Phase Il1_CGI-PS-SISymptoms SOURCE FINAL 2010 Oct II.

12. Clinical Global Impression- ROC005_GlyT I Phase lICCGI-NS-SI Source_Final_201O_0ct_II.Negative and Overall ROC005_GlyT I Phase Ill_CGI-NS-SISymptoms SOURCE FINAL 2010 Oct 11

13. Negative Symptom ROC005_GlyT 1 Phase III_NSA-16 ManualAssessment-I 6 (NSA-16) Source Final 2010 Jul 27.- - - -Instruction Manual

14. SEMI-Structured interview for ROC005_GlyT 1 Phase III_NSA-16 Interview Guide Source_Finalrating the NSA -16 2010 Oct II.

15. Negative Symptom ROC005_GlyT 1 Phase IICNSA-16 Anchors Source_FinalAssessment-16 (NSA-16) -

2010 Oct 11.February 28,2006

16. Calgary Depression Scale for ROC005_GlyT I Phase TII_CDSS Source_Final_2010_0ct_11.Schizophrenia (CDSS)

17. PANSS QuikScoreTM FOim ROC005_GlyT 1 Phase IICPANSS QuikScore Source_Final2010 Oct 11.

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 Kolsawaia8. Mr. Nishith Mehta



18. PANSS Positive and Negative ROC005_GlyT 1 Phase III_PANSS Anchors SourceFinalSyndrome Scale 2010 Aug 23

19. IQ-PANSS Positive and ROC005_GlyT 1 Phase III_IQ-PANSS Source_Final _2010_0ct_llNegative Syndrome Scale

20. SCI-PANSS ROC005 GlyT 1 Phase III SCI-PANSS Source Final 2010 Jul 13

9. Patient scales (PROs)

a. EQ-5D with Validated CertificateEnglish: 1998 EuroQol Group EQ-5DTMis a trade mark of the EuroQol GroupHindi:EQ-5D Hindi 2008 EuroQol Group. EQ-5DTMis a trade mark of the EuroQol GroupGujarati:EQ-5D Gujarati 2006 EuroQol Group. EQ-5DTMis a trade mark of the EuroQol Group

b. ZBI with validation certificateEnglish ROC005 GlyT 1 Phase III ZBI Source Final 201O Oct 11.Hindi ROC005_GlyT 1 Phase TICZBI_Hindi - India_2011_Sep_02.docx ZBI-

India/Hindi - 14 Apr 08 - Mapi Research Institute. ID4547 1ZB1-22 AU 1.0 hin-IN

Gujarati ROC005_GlyT 1 Phase IIl_ZBI~Gujarati_2011_0ct_06.doc ZB1-22-lndia/Gujarati - Version of 03 Oct 1] - Mapi Institute. 1064081 ZBI-22 TS2.0 guj-TN

c. C-SSRS BaselineEnglish

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

Institute.[053531 C-SSRS-Baseline AU3.0 hin-IN.

Gujarati C-SSRS-Baseline - India/Gujarati - Version ofFeb 10 - Mapi ResearchInstitute.1053531 C-SSRS-Baseline AU3.0 guj-IN.

d. C-SSRS Since Last VisitEnglish

C-SSRS Since Last Visit Version 1/14/09Hindi C-SSRS - Since Last Visit - India/Hindi - Version of 12 Mar 10 - Mapi

Research Institute.1053531 C-SSRS-SinceLastVisit AU3.0 hin-IN

Gujarati C-SSRS-Since Last Visit - India/Gujarati - Version ofFeb 10 - MapiResearch Institute.105353 1 C-SSRS- SinceLastVisit AU3.0 guj-IN

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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 Kolsawala8. Mr. Nishith Mehta



e. Informed Consent Guide with validation certificateEnglish Informed Consent Guide V01.IND(EN).01Hindi SearchLyte Program (Sub-optimally Controlled Symptoms)

Informed Consent GuideVersion 1.0, dated 25 October 2010Translated from English to Hindi on 30 September 2011 by OxfordConversis Ltd. [V01.lND(HT).0l]

Gujarati SearchLyte Program (Sub-optimally Controlled Symptoms)Informed Consent GuideVersion 1.0, dated 25 October 2010Translated from English to Gujarati on 30 September 2011 by OxfordConversis Ltd.[VOl.IND(GU).Ol]

f. Milestone Certificates with validation certificateEnglish Milestone Certificates VOl.lND(EN).OIHindi SearchLyte Program (Sub-optimally Controlled Symptoms)

Milestone CertificatesVersion 1.0, dated 22 October 2010Translated from English to Hindi on 30 September 2011 by OxfordConversis Ltd.[VOl.1ND(Hr).Ol]

Gujarati SearchLyte Program (Sub-optimally Controlled Symptoms)Milestone CertificatesVersion 1.0, dated 22 October 2010Translated from English to Gujarati on 30 September 2011 by OxfordConversis Ltd.[VOI.IND(GU).Ol]

2. Patient Brochure with validation certificateEnglish Patient Brochure VOl.lND(EN).OlHindi SearchLyte Program (Sub-optimally Controlled Symptoms)

Patient BrochureVersion 1.0, dated 22 October 2010Translated from English to Hindi on 30 September 2011 by OxfordConversis Ltd.[VOI.IND(HI).O 1]

Gujarati SearchLyte Program (Sub-optimally Controlled Symptoms)Patient BrochureVersion 1.0, dated 22 October 2010Translated from English to Gujarati on 30 September 2011 by OxfordConversis Ltd.[VOl.IND(GU).O I]

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57, Brahmin Mitra Mandai Society,BIW 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


h. Doctor-to-Patient Letter with validation certificate

English SearchLyte Program (Sub-optimally Controlled Symptoms), Doctor-to-Patient Letter, Version 1.0 dated 25 October 2010 VOl.lND(EN).OI

Hindi SearchLyte Program (Sub-optimally Controlled Symptoms)Doctor-to-Patient LetterVersion 1.0, dated 25 October 20 I0Translated from English to Hindi on 30 September 2011 by OxfordConversis Ltd.[VOl.TND(HI).Ol]

Gujarati SearchLyte Program (Sub-optimally Controlled Symptoms)Doctor-to-Patient LetterVersion 1.0, dated 25 October 2010Translated from English to Gujarati on 30 September 2011 by OxfordConversis Ltd.[VOl.IND(GU).OI]

I. Caregiver Animation with validation certificateEnglish SearchLyte Program (Sub-optimally Controlled Symptoms). Caregiver

Responsibilities, Version 1.0 dated 19 October 2010

Caregiver Animation [VOl.lND(EN).Ol]~--.-"

Hindi SearchLyte Program (Sub-optimally Controlled Symptoms) CaregiverAnimation, Version 1.0, dated 19 October 2010Translated from English to Hindi on 30 September 2011 by OxfordConversis Ltd., [VOl.IND(HI).Ol]

Gujarati SearchLyte Program (Sub-optimally Controlled Symptoms) CaregiverAnimation, Version 1.0, dated 19 October 2010Translated from English to Gujarati on 30 September 2011 by OxfordConversis Ltd.,[VO l.IND(GU).O 1]

j. MCCD ScaleEnglish _MCCB • MCCB HVLTR-

• MCCB AdminFm-

• MCCB _Respondents_Booklets

Hindi MCCB • MCCB Hindi HVL TR fm 1 Submission- - --

• MCCB Hindi AdminFm A Submission- - - -

• MCCB Hindi Respondents Booklet A Submission

Please also find enclosed one copy of below mentioned documents for your kind notification:

l. e-CRF NN25307 Version 2.0 -Generated On: 16 Dee 2010 17:08:00

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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



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 of team members.

At the Ethics Committee meeting held on 17/Feb/2012 your referenced letter and the above documentswere examined and discussed. After due consideration, the committee has decided to approve theconduct ofthe 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 Shelat Member Secretary Male

" Dr. Shashank Desai Clinician Male.J.

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 Pharmacol ogi st Male

9. Mr. Nishith Mehta Social scientist Male

Page70fS

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

INDEPENDENT ETHICS COMMITTEE57, Brahmin Mitra Mandai Society,

BIW Paldi Bus Stop & Jalaram Mandir,Paldi, Ahmedabad 380 006.

Deputy 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

Dr. Preeti Mehta

Chairman

Mr. Niranjan Bhagat . Mr. Guarang Shelat

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 truly,

)L~~~~~/Mr. Niranj~ BhagatChairmanIndependent Ethics Committee57, Brahmin Mitra Mandai Society,B/W Paldi Bus Stop & Jalaram Mandir,Paldi, Ahmedabad -380006,India

~ Y \ G -t .\~ D~ .,L .Date: -

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