' ' .'· 28 Nov 2012

Sanofi India Limited A-1 01, Business. Square, Sir Mathtirdas Vasanji Road, Andheri (E), Mumbai- 400 093

CLINICAL ETHICS FORUM "Sai Prasad", 1 Floor, Flat No. 6, 125/A, Sion (West), Mumbai - 400 022. (India) Tel. : (+91 22) 24038512, ·Fax: (+91 22) 24023140· Email: cef_08@hotmail.com

Subject: Approval by an Independent Ethics Committee.

Reference: . .Protocol I Study No. DIREG L 06283 I RESPONSE I :• • 4o --

Title ofJ>rot~~~' '! Stu~y: "An observational study to determine Thromboembolism prophylaxis in oncology patienis!.WhO are undergoing abdominal Or pelvic surgery.

: . CEF Ref No.: CEFI12-131033

Dear Sir,

The Clinical Ethi~s Forum, (hereinafter referred to as CEF), Sai Prasad, 1st floor, 1251A, Sion (West), Mumbai 400 Oii, India at its meeting held on 23 October 2012 at 17.30 hrs reviewed the following documents peitfiining to the above-mentioned protocol I study.

Sr. Document V ersion!Dated No.

Consent for participating - NA/Dated 03-0ct-12 1. Dr. M.G Naga Kishore

-Consent (or participating - NAIDa ted 0 1-0ct -12

2. Dr:~·::~ Krishnamurthy · <~ • ·. ~ : •. : r 1:. :: '

Consent for participating - NA/Dated 08-0ct-12 3. Or. Rayi ~umar Saxena

I • ' ' • • • •

No Objection letter -NA/Dated 03-0ct-12 4. Dr. M. G Naga Kishore

5. No Objd~tion letter- NA/Dated 01-0ct-12 Dr. S. R. Krishnamurthy

No Objection letter - NA/Dated 08-0ct-12 6. Dr. Ravi Kumar Saxena

...

Curriculum Vitae- NA/Dated 03-0ct-12 7. · Dr: M.d Naga Kishore

-. - - . . ..... 8. ; ·: cutricl)him~Vitay - NA/Dated 01-0ct-12

-~ ~or;·~~- it! ·~i~hAamurthy . . ' ...... • • ..i . ... .! · ..... i •. ~ . ...: • .;..

9. Curricuhiin 'Vitae- NA/Dated 08-0ct-12 Dr. Ravi Kuma~ ·saxena

10. Protocol:. Final Version Dated 21 st May 2012 .. .

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PEf 11.

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13.

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15.

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17.

18.

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24.

ICF English

ICF Kanpada translation

· Translation certificate (Kannada) :

ICF M~rathi translation

. Tr~ns~a~iPJ!l. certificate (Marjl;th~).. >::. ·: . -~

,: t . ·~,;,~ ~ ;; ~·!j· .l· : ·~·.~:

'IGF TamiJ"irah·sr~tion ( ..

Translation certificate {TaniilF;

· ICF Mahtyalam translation

· Transl(ltion certificate (Malayalam)

ICF Guj:;J:rati translation

Translation certificate (Gujarati) ' . ~ . :

.. 'f~n§I~tf9n c.e.rtificate (Hindi)

BhmkCRF

CLINICAL ETHICS FORUM "Sai Prasad", 1 Floor, Flat No. 6, 125/A, Sion (West), Mumbai -400 022. (India) Tel. : (+91 22) 24038512, ·Fax: (+91 22) 24023140· Email: cef_08@hotmail.com

India Version 1.0 Dated 06 June 2012

India Version 1.0 Dated 06 June 2012 Kannada translation Dated 09 Aug 2012

NA

India Version 1.0 Dated 06 June 2012 Marathi translation Dated 09 Aug 2012

NA

India Version 1.0 Dated 06 June 2012 Tamil translation Dated_09 Aug 2012

NA

India Version 1.0 Dated 06 June 2012 Malayalam translation Dated 09 Aug 2012

NA

India Version 1.0 Dated 06 June 2012 Gujarati translation Dated 09 Aug 2012

NA

India Version 1.0 Dated 06 June 2012 Hindi translation Dated 09 Aug 2012

NA

Filial Version Dated 2151 May 2012

Details of the composition of the ethics committee and those present for the meeting are given below:

Sr. No

2

. . .

·Name/ Role in EC ! ., MR.C.SHRIKHANDE i- qhairpeq;~m I ;Layperson 1 ::: h~ i·::J ~ :! ~{ : ~?~ ~ ~ /.~;: . ~~~. I r~ i ~~(t~}~;~:t ~ ~j :·t -;·: ·~·. · I l ! l . : ·. : · ... , I. ··•

~l}f~~i}~~~tf.P AT -1 Memtler ·s ectetary I b .YQ.ecologist · · · . ~ ~!; ~: ... _: ___ __ _

!; . •J, ' . • • ' ~

. ·1

. . '·

Qualification

B.Sc.

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

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Affiliation Present/ Absent

Retired International Marketing Present Consultant for SME's, social service at NAB, visiting faculty at business schools.

Private Practitioner at I) Indira Present Maternity & Surgical Nursing Home, Sion (W), Mumbai 2) Consultant Gynaecologist at I WeH~erm_g_ Medical centre.

! • •

CLINICAL ETHICS FORUM "Sai Prasad", 1 Floor, Flat No. 6, 125/A, Sion (West), Mumbai - 400 022. (India) Tel.: (+91 22) 24038512, • Fax: (+91 22) 24023140· Email: cef_08@hotmail.com

3

4

:MR: N: BHAGW AT -M~mber I Ph~aCist& Horticulturist. ·

MS. P. BHATKAR - Member I Soci~ll & NGO Worker. :

B. Pharma, M.Sc. Tech.

B.A., M.S.W.

5 DR. D. DFIODI M.D., -Member I Ph'a~acologist. (Pharmacology)

' 6 MS. S. G()GATE

,. ·1 ''! j' •.'c • '

- Membef:&~tegar :Expert

7 ~s.::K .; JW(:iri~NE -: Member} SO'cHtl & NGO ' . Wbrker.

B.Com,FCA, LLB. (G)

B.Com., LL.B., M.S.W.

8 MR. P. KHER- . M.Com., LL.B., Member I Legal Expert. A.C.S.

9 DR. (MS.) A. KULKARNI M.D. - Member I Psychiatrist.

10

11

12

13

Dr. (MS.) S. MALI - Member I Pharmacologist.

' ··' · :

MS.~ An.iaJt&r Des.ai -Tvt~B.er V. ;, tr~ga~ Expert ~. :! i-;: ~r~;~t; ::; : ~ ·· ·.! ~~Vl :<· ~~~ --·. I :

~·- -~--·-~ --~ ...... ~. :··-·--... . :, I r .. ]' "< .. . ... ~: ..

M~:. · :A:r.unitna ·Kaushik­~l;ler/ la!pe~son

M~~··Sush~u~a Shi'rodkar -rvidn1h~N l~y~~hdh

·.·>~:. ·<·

L. ~ .. ~--~-=: .. :~~:~--.\~;Lt . r i·~ ;~ .. :~~";~:.~:: !:~~;;· ;~;~ ~~:

•• j

M.D. (Pharmacology)

B.Sc. LL.M

B.A.Mathematics Hons.) Diploma in Corporate Communication Pursuing Masters in Philosophy, Astrophysics

M.Sc (Biochemistry, University of Mumbai)

Page 3 of6

Proprietor, Ankur Landscape Service, Dadar, Mumbai.

Social Worker

Lecturer in Dept of Pharmacology, Sir JJ Hospital and Grant Medical College, Byculla, Mumbai.

Practicing Chartered Accountant, Legal Expert.

Social Worker (Sakhya Women's Guidance Cell).

Practicing Company Secretary, Legal Expert.

Psychiatrist, private practice and Honorary Consultant at: 1) Dhanwantari Hospital, Dadar. 2) Manav Seva Sangh.

Assistant Professor- Dept of Pharmacology, Lokmanya Tilak Municipal Medical College, Sion, Mumbai.

1. Worked in a Nationalized Bank 2. Practiced as a Civil and Criminal Lawyer in Bombay High Court from 1985 to 2000

Marketing Consultant -Freelance & Project based

Housewife Worked as a Junior Research Fellow from year 2000-2002 and a Senior Research Fellow from 2002-2005 in University Dept. of Chemical Technology, Mumbai.

Present

Present

Present

Present

Present

Present

Present

Present

Present

Present

Present

CLINICAL ETHICS FORUM "Sai Prasad", 1 Floor, Flat No.6, 125/A, Sion (West), Mumbai - 400 022. (India) Tel. : (+91 22) 24038512, ·Fax: (+91 22) 24023140· Email: cef_08@hotmail.com

The queries raised and I or amendments/ modifications suggested by the CEF vide letter dated 25th October 2012, were satisfactorily replied to by the Sponsor and I or the Principle Investigator vide letter dated 16th November, 2012. The amended documents were reviewed and approved at the meeting held on 27th November, 2012.

The following study documents and were reviewed and approved at the meeting held on 27th November 2012.

Sr. Document Version/Dated No.

Consent for participating - NA/Dated 03-0ct-12 1. Dr. M.G Naga Kishore

Consent for participating - NA/Dated 0 1-0ct- 12 2. Dr. S. R. Krishnamurthy

Consent for participating - NA/Dated 08-0ct-12 3. Dr. Ravi Kumar Saxena

No Objection letter-NA/Dated 03-0ct-12 4. Dr. M. G Naga Kishore

No Objection letter- NA/Dated 0 1-0ct-12 5. Dr. S. R. Krishnamurthy

No Objection letter - NA/Dated 08-0ct-12 6. Dr. Ravi Kumar Saxena

Curriculum Vitae - NA/Dated 03-0ct-12 7. Dr. M.G Naga Kishore

8. Curriculum Vitae - NA/Dated 0 1-0ct-12 Dr. S. R. Krishnamurthy

9. Curriculum Vitae - NA/Dated 08-0ct-12 Dr. Ravi Kumar Saxena

10. Protocol Final Version Dated 21st May 2012

11. ICF English India Version 1.0 Dated 06 June 2012

12 ICF Kannada translation India Version 1.0 Dated 06 Jun~ 2012 Kannada translation Dated 09 Aug 2012

13. Translation certificate NA (Kannada)

14. ICF Marathi translation India Version 1.0 Dated 06 June 2012 Marathi translation Dated 09 Aug 2012

15. Translation certificate NA {Marathi)

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;

16. - ~Cf.J-~filit.;t~~sr~t~on : . I'..; .. . .;: <·I •• 1 1,1

·.1 't:;__:" ."~r ~ ( .. :j .' l~ · :: '· : .

'; ,, ~. I ·;1~ .11 , !,;1 ,:.';j I t: •t: 17. ~: · rtbin~)a:tioh:· ceitificate

·; .. (Tainit) · .. · · ·

18. ICF Malayalam translation

19. Translation certificate (Malayalam)

20. ICF Gujarati translation

t

21. Translation certificate (Gujarati)

22. ·· ··reF Hindi translation

23. · ~ra·nsl~t~~n ·ceftificate (Hindi) . ..

24. Bta~·CRF . . . ·-. ·- ... - ··~ · - . . ·-. . . .

CLINICAL ETHICS FORUM "Sai Prasad", 1 Floor, Flat No. 6, 125/A, Sion (West), Mumbai -400 022. (India) Tel.: (+91 22) 24038512, • Fax: (+91 22) 24023140· Email: cef_08@hotmail.com

India Version 1.0 Dated 06 June 2012 Tamil translation Dated 09 Aug 2012

NA

India Version 1.0 Dated 06 June 2012 Malayalam translation Dated 09 Aug 2012

NA

India Version 1.0 Dated 06 June 2012 Gujarati translation Dated 09 Aug 2012

NA

India Version 1.0 Dated 06 June 2012 Hindi translation Dated 09 Aug 2012

NA

Final Version Dated 21st May 2012

The CEF ·approves the study to be conducted in its presented fonn, subject to the approval of the Drugs Controller-General (India) and /or all the regulatory authorities, if I as required. Conditions, if any, imposed hy ~he DCGI or any applicable regulatory authority have to be strictly adhered to. Review_an_d apprQval ofthis study by the CEF is not an endorsement of the study or its outcome.

A copy of the relevant insurance policy which covers compensation to the participant in case of injury and I ordea.th should-be sent to the CEF before commencement of the study, ifthis is required by .. . . . regulatory at.Jtho_rities.

~ ' • I I

The pr~s~~~~PP..~gva1 ~is o.yalia only if study is initiated within one year from the date of approval. ) , . '

The m~~bers preseEL~er~ more than the required quorum of five, with at least one medically qualifiecf-person::anct at "least one layperson present. All the members voted for approval and none voted against. -:-·::-- --·· -· .

We herieliy...confirm tbaLneither you nor any of your study team members have participated in the voting/ decision ma~ing procedure of the committee. The members of the committee who have participated in thei'·vo"fing/ ~ecision making procedure of the committee do not have any conflict of interest iri:the referenced study.

• ' . .

Please d() not implement a.'ny deviation from I or change to, the protocol approved without the prior written approval of t~is ethics committee. Deviations/ changes to the approved protocol may be implemerite<i without ·prior approval of this ethics committee only when necessary to eliminate immediate hazards to subjects or when changes involve only logistical or administrative aspects of the trial [e.g. change of study monitor(s), telephone numbers(s)].

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CLINICAL ETHICS FORUM "Sai Prasad", 1 Floor, Flat No. 6, 125/A, Sian (West), Murnbai - 400 022. (India) Tel.: (+91 22) 24038512, • Fax: (+91 22) 24023140· Email: cef_08@hotrnaitcorn

Kindly ensure the CEF is informed of aJl modifications or deviations in the protocol. Any modification of I amendment to the protocol must be approved by the CEF. The Investigator is required to conduct the study as per the recommended GCP guidelines.

Kindly keep the CEF informed about the progress of the study, any SAE which may occur in the course of the study and any changes to the protocol and patient information I informed consent forrnls and new information that may adversely affect the safety of the subjects or the conduct of the study.

The Principal Investigator is requested to submit the progress report within six months, after completion of the study, to the CEF for review.

We confirm that our ethics committee is constituted and functions as per the Good Clinical Practices guidelines issued by the Central Drugs Standard Control Organization, the Schedule Y of the Drug and Cosmetics Act 1940, as amended from time to time, the Ethics Guidelines for Biomedical Research on human subjects, issued by Indian Council of Medical Research and Declaration of Helsinki, 1964, as modified by the World Medical Association, Seoul, 2008 and updated I amended from time-to-time.

Yours sincerely,

For Clinical Ethic

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