Ethics Committee For Resear On Human ubjects...2. Final Clinical Trial Agreement (CTA) 3. Agreement on Financial Arrangements dated 5thOctober 2011 4. GCP training certificate of Dr.

Ethics Committee For Resear On Human ubjects Seth GS Medical College and KEM Hospit al

Establish ed in 1986

Recognized by: Strategic Initiative for Developing Capacity in Et hical Review (SIDCER), Forum for Ethical Review Committees in Asia and the Western Pacific Region (FERCAP)

for its compliance with international and local standards in ethical review Dr. M. L. Kothari Dr. Sunil Kuyare

Chairperson Member Secretary

1i h November 2011

To,

Dr. N. J . Gogtay ,

Dept. of Clinical Pharmacology.

Ref: Your project no. EC/PHARMA-2G/2011 entitled , Clinical trial protocol , "A phase III, open label,

randomized , parallel group , multicentric trial comparing the safety and efficacy of fixed dose

combination tablets of arterolane maleate and piperaquine phosphate(PQP) with chloroquine

tablets in patients with acute uncomplicated Plasmodium vivax malaria" Study number

R2011005, Version number 2, dated 20.7.2011 supersedes vers ion 1 dated 28.06 .2011.

Sub: Letter no. DCP/II/772/2011 dated 24th October 2011 regarding submission of response to the

ECRHS letter.

Dear Dr. Gogtay,

The meeting of the Ethics Committee for Research on Human Subjects (ECRHS) was held on

13th September 2011 at 1:00 pm. in the Clinical Pharmacology Seminar Hall with Dr. Manu Kothari

as !he Chairperson.

13th Thirteen members attended the meeting held on September 2011. The list of members who

attended the meeting is as follows .

Name of Members Position on

Ethics Committee

Designation & Affiliation

-

Qualification

M.S., M. SC. (Anatomy)

1. Dr. Manu Kothari Cha irperson (External )

2. Dr. Sunil Kuyare Member Secretary

. Assistant Professor, (Microbiology) GSMC & KEMH

Professor and Head (Ped iatrics) TN Medical College and BYL Nair Hospital.

Professor (Obstetrics & Gynaecology) N. Wadia Maternity Hospital

M.D., DHA, FME.

M.D., D.C.H.

M. D., DNB., F.C.P.S., D.G.O., D.F.P.

M.Com

3.Dr. Sandeep Bavdekar Member (External Scientific Expert)

4. Dr. Kaizad Damania Member (External Scientific Expert)

5. Mrs. Manisha Naik Dalal

Member (External Layperson)

-

Page 1 of 4

Address: Room no. 46 , Old Hospital Building, Next to Medicine Seminar Hall , Second Floor, Seth G.S; Medical College and K.E.M. Hospital, Parel, Mumbai 400 012. Mobile: +91 9820757259, Tel: +91224107515. Tel. & Fax No. +91224122188 email: [email protected]

Ethics Committee For Rese rc n uman Subiects Seth GS Medical College and KEM Hospital

Established in 1986

Recognized by: Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), Forum for Ethical Review Committees in Asia and the Western Pacif ic Region (FERCAP)

for its compliance with international and local standards in ethical review Dr. M. L. Kothari Dr. Sunil Kuyare

Chairperson Member Secretary

6. Dr. (Mrs.) Helen Joseph Member (External Social Worker)

Faculty Member College of Social Work of Nirmala Niketan Institute

7. Dr. Sandhya Kamat Member

Member

Member

Member.

Member

Professor, (Pharmacology& Therapeutics) GSMC & KEMH Associate Professor (Pharmacology& Therapeutics) GSMC & KEMH Professor, (Medicine) GSMC & KEMH Associate Professor, (Anesthesiology) GSIVIC & KEMH Assistant Professor, (pharmacology & Therapeutics) GSMC & KEMH

8. Dr. Padmaja Marathe

9. Dr. Milind Y. Nadkar

10. Dr. Sweta Salgaonkar

11. Dr. Yashashri Shetty

12. Dr. Urmila Thatte Member

Member (External Legal Expert)

Professor & Head (Clinical Pharmacology) GSMC & KEMH Medical Director, Ghatkopar Hindusabha Hospital, Mumbai

13. Dr. D. N. Upasani

M.S.W.; M. Phil., Ph.D.

M.D.

M.D.

M.D., FICP

M.D.

M.D.,DBM.

M.D., DNB., Ph.D.

M.S., L.L.B.

It is to be noted that neither you nor any of your proposed study team members were present during

the decision-making procedures of the Ethics Committee for Research on Human Subjects.

The ECRHS reviewed the above - mentioned clinical study arid approved the following

documents submitted for this clinical study at the meeting.

1. Clinical study protocol Study number R2011005, Version number 2, dated 20.7.2011 supersedes

version 1 dated 28.06.2011.

2. A copy of Investigators undertaking signed on 11 th August 2011

3. Study Code: R2011005 Informed Assent Document (lAD) Version 2, dated 20 July 2011 in

English, Hindi and Marathi

4. Fixed dose combination of arterolane (RBx11160) maleate + piperaquine phosphate Investigator's

Brochure Version number 6, release date 14 February 2011 replaces previous version number 5

release date 4th September 2009.

5. Case Report Form Study number R2011005, CRF Version number 2.0, dated 21/7/2011

supersedes version 1.0, dated 29.06.2011.

6. Common terminology criteria for adverse events v3.0(CTCAE) Publish date: August 9, 2006

7. Sample label template (primary pack) version 1 dated 28.6.2011

8. List of prohibited medications version 1 dated 28.6.2011

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Address: Room no. 46, Old Hospital Building, Next to Medicine Seminar Hall, Second Floor, Seth G.S. Medical College and K.E.M. Hospital, Parel, Mumbai 400 012. Mobile: +91 9820757259, Tel: +91 22410 7515. Tel. & Fax No. +91 224122188 email: [email protected]

Ethics Commit ee For R n an Subj cts Seth GS Medical Coli ge and KEM Hospital

Established in 1986 Recognized by: Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), Forum for Ethical Review Committees in Asia and the Western Pacific Region (FERCAP)

for its compliance with international and local standards in ethical review Dr. M. L. Kothari Dr. Sunil Kuyare

Chairperson Member Secretary

9. List of change Appendix D Study number R2011005, Version number 2, dated 20.7.2011

supersedes version 1 dated 28.06.2011

10. Medication compl iance card Version 01, da ted 20 july 201 1 in English, Hindi and Marathi

11. Key contact information, vers ion 2; dated 11 August 2011

12. A copy of DCGI permission letter dated 09 Aug 2011 .

13. A copy of delegation of responsibilit ies of study team .

14. A copy your curriculum vitae signed on 1yth August 2011

15. A copy of your GCP training certificate.

16. Curriculum vitae of Dr. Urmila Thatte signed on 18th August 2011, Dr. Amar Pazare and 1yth

August 2011 and Dr. Saket J. Thaker signed on is" August 2011

17. GCP training certificate of Dr. Urmila Thatte and Dr, Amar Pazare

18. A copy of insurance certificate Policy period (01/30/2011 to 01/30/2012).

SUbsequently the following documents were received by the ECRHS on 24th October 2011 and were

reviewed and approved .

1. A copy of CTRI acknowledgement number: REF/2011/08/002676

2. Final Clinical Trial Agreement (CTA)

3. Agreement on Financial Arrangements dated 5thOctober 2011

4. GCP training certificate of Dr. Saket Thaker

5. Site No. 03 Study Code: R2011005 Informed Consent Document (ICD) Version 2.1, dated 03

October 2011 in English, Hindi and Marath i

The ECRHS hereby approves the proposal entitled , Clinical trial protocol, "A phase III, open label,

randomized, parallel group, multicentric trial comparing the safety and efficacy of fixed dose

combination tablets of arterolane maleate and piperaquine phosphate(PQP) with chloroquine

tablets in patients with acute uncomplicated Plasmodium vivax malaria" Study number

R2011005, Version number 2, dated 20.7.2011 supersedes version 1 dated 28.06.2011.".

It is understood that the study will be conducted under your direct ion, in a total of 80

SUbjects, at Dept. of Clinical Pharmacology, Seth G. S. Medical College and K.E.M. Hospital as

per the submitted protocol.

This approval is valid for the entire duration of the study.

It is the policy of ECRHS that it be informed about any ser ious adverse event occurring during

the course of the study within seven working days of the occurrence of the adverse event. If

'Death' is a SAE , it should be reported to the ECRHS within 24 hours of its occurrence via an

email.

Page 3 of 4

Address: Room no. 46, Old Hospital Building, Next to Medicine Seminar Hall, Second Floor, Seth G.S. Medical College and K.E.M. Hospital, Parel, Mumbai 400012. Mobile: +919820757259. Tel: +91224107515. Tel. & Fax No. +91224122188 email : [email protected]

Ethics Committee For Re ar uma Subjects Seth GS Medical College and KEM Hospi t al

Established in 1986 Recognized by: Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), Forum for Ethical Review Committees in Asia and the Western Pacific Region (FERCAP)

for its compliance with international and local standards in ethical review Dr. M. L. Kothari Dr. Sunil Kuyare

Chairperson Member Secretary

No deviations from, or changes of the protocol and Informed Consent Document should be

initiated without prior written approval by the ECRHS of an appropriate amendment The ECRHS

expects that the investigator should promptly rep.ort to the ECRHS any deviations from, or

changes of, the protocol to eliminate immediate hazards to the trial SUbjects and about any new

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

For studies which will continue for more than a year, a continuing review report needs to be

submitted within 1 month of the due date i.e. 13 months from the date of approval on or before

1ih December 2012.

A copy of the final report should be submitted to the ECRHS for review.

Sincerely yours,

Y! ~\\~

Dr. Sunil Kuyare Member Secretary Date of approval of the study: 17/11/2011

Page 4 of 4

Address: Room no. 46, Old Hospital Building, Next to Medicine Seminar Hall, Second Floor, Seth G.S. Medical College and K,E.M. Hospital, Parel, Mumbai 400 012. Mobile : +91 9820757259, Tel: +91 22410 7515. Tel. & Fax No. +91 224122188 email: [email protected]