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 27-Aug-2011

To

Dr Kirushna Kumar Meenakshi Mission Hospital and Research Centre Lake Area Melur Road Madurai Tamil Nadu - 625107

Ref Protocol No RLSITP 2010107 -Prospective multi-centric open label two arm parallel group active contr~l randomized comparative clinical study to evaluate efficacy and safety of R- TPR-017 I MabTherareg in patfients with Follicular B-Cell Non-Hodgkins Lymphoma

Sub EC Approval for Study Documents

Dear Dr Kirushna Kumar

With reference to the above subject we write to inform you that the Ethical Review Board in its meeting started at 1500 hrs and ended at 1700 hrs on 25-Aug-2011 held at Meenakshi Mission Hospital 8 Research Centre Madurai reviewed the documents mentioned in your submission letter dated 28-Jun- 2011

1 Clinical Study Protocol Protocol No RLSTP2010107 Version 03 dated 070511

2 Inve~igator Brochure Protocol No RLSTP2010107 Version 02 dated 170511

3 Subject Information Sheet and Informed Consent Form for participation in the study Version 3 dated

07105111 in English

4 Subject Information Sheet and Informed Consent Form for participation in the study Version 3 dated

070511 translated on 1410611 from English to Tamil

5 Investigator Study Undertaking

6 Consent Letter of Principle Investigator

7 Investigators CV

8 DCGI Approval Letter

9 Insurance Policy

The Ethical Review Board Meenakshi Mission Hospital and Research centre Madurai has conducted an ethical review of the documents for the above referenced clinical study The IEC reviewed the following documents 8 grants its approval

The following members attended the IEC meeting for the review of this clinical trial

S No Name of the member Role in the EC Qualification Affiliation [Designation ITitle Name and Address (City State)

of Affiliated Institute]

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

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) 25887~1 (10 Lines) 4263000 (6 Lines) Fax (91 -452) 2586353

E-mail mmhrcsancharnetin Web http wwwmeenakshimissionorg

2 Dr V N Rajasekaran

Members Secretary Basic Medical Scientist Clinician

PhD( Hookwork Nutrition) MD DTM amp H

i

Medical Director MMHRC Madurai Tamil Nadu

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 Microbiologist MMHRC Madurai Tamil Nadu

6 1 Dr KPadmini

Basic Medical Scientist

MD (Microbiology)

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 expert Clinici an

MS MCh (Uro) MBA BG L

Acedamic Director MMHRC Madurai Tamil Nadu

bull We conffrm that neither you nor your study team members participated in the deliberations of the Ethics Committee amp did not vote on the proposal for this study

Promptly report to the IEC bull Any changes to or deviations to the protocol approved by the IEC that you may implement to eliminate

hazards to the trial subjects

bull All serious adverse events

bull New information that may affect adversely the safety of the subjects or the conduct of the trial

Please submit to the IEC the status report of the study after every 12 months interval I

The IEC is organized amp operates according to the requirements of ICH-GCP amp Indian Council of Medical Research amp Schedule Y

Cordially yours

ampgt ~ 27 ~Member secretary __~~=_______ Date d-u O- [ f

THE SECRETARY ETHCAL REV EW BOARD V1eenakshi M ission Hospita l and ~e f9 arch Centre

iake Area Melur Road MADURAI-625107