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Ethical Trial of Health In Community(ETHIC) Committee_ .._ .._ ..-.._ .._ .._ ..-.._ .._ ..-.._ ..-..-

Date: 23 Feb 2012.

Or. Kapil Thakkar,Consultant Urologist & Endrologist

Excel Hosp/ta - An Advanced Laparoscopy & Urology CentreSural

Sub: Approval of the protocol No. CLR_08_10

Dear Dr.Kapill Thakkar,

On 23 Feb 2012 the Ethics Committee met, reviewed and discussed your application dated 23 Jan 2012to conduct the clinical trial entitled "A nmdomised, mutticenter, phase-lll study to test the therapeuticequivalence, safety and pharmacokinetics of a new monthly depot formulation (3.75 mglmonth) ofleuprollde acetate (Leuprollde Sun 3.75 mg) versus LUCI1nrl1'In subjects with locally advanced andmetastatic prostate cancer."

The following documents were reviewed dOOnothe meet/no:Sr. No. Document Noo(

eopies1. Study protocol CLR_08_IO Version 01, Amendment 00 dated 13 Oct 201 L .09

2. Protocol Signature Page Signed by Investigator dated 12 Jan 2012 09

Investigators Brochure for Lcuprolide acetate for depot suspension, Version 093.01, dated 10 Oct 2011

4. Case Record Form Version 0 I dated 31 Oct 2011 09

Patient Information Sheet and Informed Consem Form in English; Version 095.01, dated 02 Nov 2011.

Patient Information Sheet IIlJd Informed Consent Form in Hindi; VersiOn 01, 096.dated 02 Nov 20T 1.

Patient Information Sheet and Informed Consent Form in Hindi Back 097.Translation; Version OT, dated 02 Nov 2011.

Patient Information Sheet and Informed Consent Form in Gujarathi; Version 098.01, dated 02 Nov 2011.

Patient Information Sheet and Informed Consent Form in Gujarathi Back 099.Translation; Version 01, dated 02 Nov 20T I.

10. English consent form for HIY test Version 02 dated 14 Dec 201 I 09

II. Hindi consent form for HJV test Version 02 dated 14 Dec 2011 09

Back translation Hindi consent form for HIV tC5t Version 02 dated 14 Dec 0912.2011

13. Gujarathi consent form for HlV test Version 02 dated 14 Dec 2011 09

Page 1 of 3- .._ ..- .._ .._ ..- .._ .._ .._ .._ .._ .._ .._ .._ ..- .._ .._ .._ ..-"-"_"_1._ .._ .._ .._ ..- ..Shop No: 16 (B), 3rd Floor, Sheela I Shopping Square

(Old LB Cinema), Ghod Oed - Bhalar Road Junction, Surat - 395 001, Gujarat; India.

------------------_._------ --------

Ethical Trial of tlealth In ~ommunity- - (ETHIC) Committee_ .._ ..-.._ ..-_ .._ .._ .._ .._ .._ .._ .._ .._ ..

Back tranSlation Gujatathi consent form for HIV test Version 02 dated 1409

14. Dec 2011

15.Investigator's undertaking dated 12 Jan 2012

09

16. Investigator's consent dated 12 Jan 201209

Investigator's CV dated 12 Jan 2012 and Medical Registration Certificate09

17. (MRC)

18.Insurance Statement and Certificate from 08 Oct 2011 to 07 Oct 2012

09

19. Draft Clinical Study Agreement09

20. Draft Financial Agreement09

21. Copy ofTempotarY erRl Registration.09

During its meeting, the, EC decided to approve the conduct of the above study In its presented form at

Excel Hospltal- AA Advanced Laparoscopy & Urology Centre, 8-15, 3rdFloor, Sheetsl ShoPping Squqre.

(Old LB Cinema), Ghod dod - Bhatar Road Junction, Surat - 395 003 , Gujarat. India.

esentfvoted in

Sr. Name Qualification Designation In Designation

NolEe

1. Dr. Devang Patel M.B.B.S., D.A. Chairman Anesthesiologist

(Anesthesiology)

2. Dr. Dharmesh Bhuptani M.S. Member ConsUltant Ophthalmologist

(OphthalmOlooVl secretarY

3. Mr. Nilesh ShuKla B.Com.,LLB. Member Legal Expert

4. Dr. Vinesh Shah M.D .• S.L.G. Member Basic Medical Scientist

(Forensic Medicine)

5. Dr. Manish Mehta M.S. Member Consultant Laparoscopic

(General Suroerv)Surgeon

6. Dr. Mehul BhaVSar M.D. (Medicine) Member Consultairt Physician

7. Mr. Chirag Itchaporia D.Pharm Member Chemist

6. Mr. Manish Pathak H.S.C. Member Priest & Social Worker

9. Mrs. Darshna Thakkar Graduate Member- House wifeLa

Page 2 of3

It is also confirmed that neither you nor any of the study team members participated in the voting

procedure.

Shop No: 16 (B), 3rd Floor, Sheetal Shopping Square(Old LB Cinema), Ghod Dod. Bhatar Road Junction, Surat - 395 001, Gujarat; India.

-" _ .._ ..-" _ ..-" -" _ ..-..-,'-' .-.._ .._ .._ ..-"-" -" _ ..-" -"-" _ ..-.._ .._ .._ ..

Ethical Trial of Health In Community(ETHIC) Committee_ .._ .._ .._ .._ ..-.._ ..-.._ .._ ..-.._ ..-..-

You are requested to report to the Ethics committee the following:

•• All deviations from, or changes of, the protocol to eUminate immediate hazards to the studysubjects.

•• Changes that increase the risk to participating subjects and/or those that significantly affectthe conduct of the study.

•• AUserious adverse events.•• New infonnatlon that may affect advernely the safety of the subJects or the conduct 01 the

study.•• MY changes in the study documents.•• Progress of the study and the final report.

Note :

Do not start the study at your centre without submission of DCGI Approval letter.

Thanking you,

Yours sincerely,

M~Etical Trial or Helth In CommuJllty (ETHIC) CommitteeShop No: 16-8(2), 3rd Floor, Slteetal Shoppb,C Sqllare,(Old LB Cinema), Glaod dod-Dbatar Road Junction,Surat-39S 001. Gujarat. ladla.

O'7J ' ~ e.\./C"-'(j raJ-Q,L C'Cr,Cl...l;l:'V'\./\.C{'A'-)

Ethical Trial of Health InCommunity (ETIHC) Committee

p.,~'--'I J I '10 I 'l.---{:!!5'. I e~ ~"2.

Trustee IAuthorised SIgnatory

i:: ~.{: .

Page 3 of 3- .._ .._ .._ ..- ..- .._*._ .._ .._ .._ .._ .._ .._ .._ .._ .._ .._ ..- .._ .._ .._ ..- .._ ..- .._ ..- ..Shop No: 16 (8), 3rd Floor, Sheetal Shopping Square

(Old LB Cinema), Ghod Oed - Bhatar Road Junction, Surat - 395 001, Gujarat; India.