- MEENAKSHI MISSION HOSPITAL AND RESEARCH CENTRE (Run by SR TRUST)

Lake Area Melur Road Madurai - 625 107 Tamilnadu India

ETHICAL REVIEW BOARD Phone (91 -452) 2588741 (10 Lines) 4263000 (6 Lines) Fax (91-452) 2586353

E-mail mmhrcsancharnetin Web httpwwwmeenakshimissionorg

Date 25-Mar-2011 To Dr Krishna Kumar Rathoam Meenakshi Mission Hospital and Research Centre Lake Area Melur Road M adurai-625107

Reference Protocol CA180-226

Subject Ethics Committee approval for conduct of above referenced study at meenakshi mission hospital and research centre lake area melur road Madurai-625 107 for study conduct

Dear DrRathnam We have received your letter dated 14-Feb-20 11 from you submitting the following documents information for the above referenced stud y

SrNo Document Details with VersionlDate 1 CA 180-226 Revised protocol-02 (04-0ct-20 1 0) Synopsis included ltpages 4 to 6gt

2 CA 180-226 Protocol Amendment Ii 7 (04-0ct-20 I 0)

3 Administrative Letter 02 (09-Sep-20 10)

4 Subject Information Sheet amp rCF (English)-India specific version 10 dated 06-0ec-20 10

5 Subject Information Sheet amp ICF (Tamil)-lndia specific version 10 dated 06-0ec-201 0

6 Translation Certificate for Subject Information Sheet amp rCF (Tamil)-India specific version 10 dated 06-0ec-20 1 0

7 Subject Information Sheet amp JCF (Malayalam)-India specific version 10 dated 06-0ec-20 10

8 Translation Certificate for Subject Information Sheet amp ICF (Malayalam)-lndia specific version 10 dated 06-Dec-2010

9 Subject Assent (Engl ish)-India specific version 10 dated 06-0ec-20 10

10 Subject Assent (Tamil)- India specific version l0 dated 06-0cc-20 10

11 Translation Certificate for Subject Assent (Tamil)-India specific version JO dated 06-0ec20 J 0

12 Subject Assent (Malayalam)- India specific version 10 dated 06-Dec-201 0

13 Translation Certificate for Subject Assent (Malayalam)-lndia specific version lO dated 06Dec-20JO

14 Subject Recruitment Poster

15 PatientCaregiver Brochure

16 CISCRP Brochure

17 Medication Bag ltpicture enclosedgt

18 Glass ltpicture enclosedgt

19 MagneticDry Erase Calendar ltpicture enclosedgt

EENAKSHI MISSION HOSPITAL AND RESEARCH CENTRE (Run by SR TRUSn

Lake Area Malur Road Madurai - 625 107 Tamllnadu India

ETHICAL REVIEW BOARD Phone (91-452) 2588741 (10 Lines) 4263000 (6 Lines) Fax (91-452) 2586353

E-mail mmhrcsancharnetin Web htlp wwwmeenakshimission org

20 Subject Medication Diary (English)

21 Subject Medication Diary (Tamil)

22 Translation Certiflcate for Subject jyjedication Diary (Tal11il)

23 Subject Medication Diary (Malayalam)

24 Translation Certificate for Subject Medication Diary (Malayalam)

25 Pregnancy Prevention Information Sheet (Engl ish)

26 Pregnancy Prevention InfoIl11ation Sheet (Tamil)

27 Translation Certificate for Pregnancy Prevention Information Sheet (Tamil)

28 Pregnancy Prevention Information Sheet (Malayalam)

29 Translation Certificate for Pregnancy Prevention Information Sheet (Malayalam)

30 SAE Submission process followed at BMS India

31 Copy of e-CRF

32 DCGI submission lettel for conduct of study [Awaiting Approval from DCGI]

33 Draft Clinical Trial Agreement

34 Dasatinib Investigators Brochure version 10 dated 03-Nov-20 I 0

[No Safety Updates (ESRsl post this 18 have been reported]

35 Clinical Trial Registration Certificate [Registration -pellding-REFCTRI-OOO 128J

36 Letter regarding Provision of Insurancellndemnity

We have also noted proposed methods for patient accmal and patient retention in the study

At the Ethics Committee meeting held on 24-Mar-20 11 these documents were examined and discussed After due consideration the committee has decided to approve the conduct of this study the aforementioned documents and the proposed methods for patient accrual and retention

We have also noted

bull Your current signed and dated CY as a token of credentials for the conduct of the study

bull A copy of the undertaking (per the revised schedule Y of drugs and cosmetics rules 1945) including

list of study team members

The members who attended the EC meeting held on 24-mar-20 11 at which your proposal was discussed are as follows

MEENAKSHI MISSION HOSPITAL AND RESEARCH CENTRE (Run by SR TRUST)

Lake Area Melur Road Madurai - 625 107 Tamilnadu India

ETHICAL REVIEW BOARD Phone (91 -452) 2588741 (10 Lines) 4263000 (6 Lines) Fax (91 -452) 2586353

E-mail mmhrcsancharnetin Web httpwwwmeenakshimissionorg

SNo -

Name of the member Role in the EC Qualification Affiliation [DesignationlTitle Name and

Address (City State) of Affiliated Institute]

1 Dr AVelmurugan Chairperson PhD( N) MSc (N) Professor in N ursing (Not affiliated with MMHRC)

2 Dr VNRajasekaran

Member Secretary Basic Medical Scientist Clinician

PhD( Hookwork N ) M 0 DTM

utntlOn amp H

I

Medical DIrector MMHRC Madural TamIl

d Na u

3 Dr TRMurali Clinician MS MCh (Uro) Senior Consultant Urologist MMHRC Madurai

Tamil Nadu

4 Dr OLSadasivam Clinician MS (Surgery) Consultant Surgeon MMHRC Madurai Tamil

Nadu

5 Dr Bhuvaneswari Clinician MD DGO (OampG) Consultant Gynecologist MMHRC Madurai

Tamil Nadu

6 Dr KPadmini Basic Medical Scientist

MD (Microbiology) Microbiologist MMHRC Madurai Tamil Nadu

7 Ms NChitra Social Worker Philosopher

MA MPhil MBA MSc (Psy)

Counselor MMHRC Madurai Tamil Nadu

8 Mr PTSundar Lay person MA Executive Secretary to Chairman MMHRC

Madurai Tamil Nadu

9 Dr NKirshnamurthy Legal expertC linician

MS MCh (Uro)

MBA BGL

Acedamic Director MMHRC Madurai Tamil

Nadu

It is hereby confirmed that neither you nor any of the study team members have participated in the votingdecision making procedures of the committee (include this statement only if the PIstudy team member is part of the EC)

Wed like to take a note of the following during the conduct of the studyshy

Any serious adverse event that occurs during the conduct of the study at meenakshi mission hospital and research centre lake area melur road Madurai-625I 07 should be reported to the Ethics Committee as per the schedule Y requirements

We also require that a report of the study be sent to us the Ethics Committee annually

Yours truly

Date Q5 - vIctrr ~ I ~1sekaran THE SECRETARY Member Secretary Ethic~ltf~eREVEW BOARP

v1 eenakshi M iss ion HospItal and

rl esna rch Cent re

Lake Area Melur Road MADURAI - 625 107