ry:r J I b 3 b

II{STITUTIONAL ETI{ICS CONIMI'I'TEEDEENANAI'II MANGESHKAR HOSPITAI, .t RESEARCTI (

ERANDAWANE, PUNE - 411 004 . TEL : (91 ) 66023000 / 40151000 . FAX : (91 ) 0E-mail : research@dmhospital.org Website : www.dmhospital.org

(The Institutional Ethics Commitfee of Deenanath Mangestrkar Hospital & Resoardr Centre works as p€r its Work Do(

iOer p". provisions of Good Clinical Practices, IClv{R Code 2000, Ethical Guidelines for Biomedical Researchparticipants ICMR 2006, Guidelines for Clinical Trials on fharpraceuticat Products in India, CDSCO, DGI{S' GCP, Gor

Schedule 'Y' in particulaq and ICH Good Clinical Practice CruidFlines.)

ToDr. Chetan DeshmukhPrincipal Investigator

Dear Dr. Chetan Deshmukh

Ref: Your letter dated '2Slll.n0|I

The Institutional E&ics Committee reviewed and discussed your application to review thr

the Protocol entitled, oPrntocol no: "CP/13/l0AMulti-Centre Prospective, Open Lah

On Safety And Efiicacy Of Letrozole As Adjuvant Treatment Of Post-Menopausal

With Hormone Receptor Positive Early Bre$t Cancer.."

The following documents were reviewd:

I 'NTER,0 25420104

GEN 05€

rcnt andHuman

of India

ICF forI Study

Sr.No.

Document Name Document Details (Version d Date)

I Patient Information Sheet, Engf ish Version/Date : 1.1124 June 201

2 Patient Information Sheet, Hindi VersionlDate: l.ll24 June 2011 ,'from Bnglish to Hindi on 28 Junt

'ranslated

20 l l

aJ Patient Information Sheet, Back

translation Hindi to EnglishVersionlDate : l.l l24hne20 I I'BTranslated from Hindi to Englisft20lr

rckon 28June

4 Patient Information Sheet, Marathi Version/Datet l.ll24 June 201from English to Marathi on 28 Jt

i , Translatedne 20ll

5 Patient Information Sheet, BaOktranslation Marathi to English

VersionlDate: 1.1/24June 201 1,1Translated from Marathi to Engl20lr

ackrh on 28June

The IEC approves the above documents to be conducted in its presented form.

L.H. Rwised :01lO8lO7

The following members ofthe Institutional Ethics256 November20ll at 400 pm at Deenanattr Mar

Committee were present at the meeting€eshkar Hospital and Research Celrtre.

on

l Dr. B. Y. Pawar M.D.IDCC Basic Medical Scientis

2 Dr. Prema Shidore M.D. Pharmaccogy Pharmacologist

3 Dr. ManoharDhadphale

M.B.B.S.,DPMMD, FRCP (Ps.

MCRP(Psych)ch)

Social Scientist

4 Dr. Sujala Watve B.Sc.,M.A., PhD Ethicist

5 Adv. Sheel Rege B.A.,L.L.B. Legal Expert

6 Mrs. Aaratee Gadkari M. Sc. (Microb ology) Lay Person

7 Col.J.C.Pendse, VSM(Retd.)

B.A. (Hons) Member Secretary

Please note that the Principal Investigator was i

other study staffmenrbers did not participate in th

The Institutional Ethics Committee expects (i) yo

be informed about the progress of the study' (iii)

course of the study, (iv) to be informed ab<

information/informed consent and (v) to be provit

Please be informed that the approval for a clinic:

and is for duration of two ye:lrs or for the stipuk

othErwise. In case ofapproval for any other stud

the date of this letter and is effective only till th

the study is not completed within this time frame'

approval for the study at least two months prtor tt

Yours sincerpfy,, V r , il ' ltt '-d)"

col J.c. rfrase fsm G"ta.)Member Secretary, IEC-DMH&RC'

f-t , :l l -=

\

Deenantth Mangeshkar Hospital & Research

nvited to explain the protocol. He/She arp decision making / voting procedures-

u to abide by Privacy and Confidentiality, '

to be inforrred about any SAE occurring i

)ut any changes in the protocol and p

led with a coPY ofthe final report.

rl trial protocol starts from the date of this

ited duration, whichever is less, unless spe

y related document/s, approval woul{-slaf

I U*i" protocol approval remains valid' It

, an ap,pii"ation should be made for renewir

r the end ofaPProval Period'

ffi/ Mangeshtar \3 \\I HospiraiE l3 l l\ Research /5'l;'We/'

Date of Issue- 2'vCentre

i l o r

ii) tor the

r \ a

letter:ifiedfromcase

Ls the

o \.I-

o'ft;IJJ

;ffi

(,. INSTITUTIONAL ETHICS CON,IMII'TEEI DEENANAT'I'I MANGESHKAR HospITr\I- ct RESEARCH' ERANDAWANE, PUNE - 4 j j oo4 . TEL : (91 )66023000 t401s j000 , FAX: (e1 )

E"mail : research@dmhospital.org Website : www.dmhospital.org

provisions of Good Clinical Practices, ICMR code zooo, rurica orioaitres for Biomedical Reseucli on Hurnan participGuidelines for Clinical Trials on Pharmaceutical Products in Indi4 CDSCq DGHS, GCp, Govt. of Indi4 S.frrO"f" .V'ICH Good Clinical Practice Guidelins.)

To'Dr. Chetan DeshmukhPrincipal Investigator

Dear Dr. Chetan Deshmukh.

Ref: Your letter dated 2AOSnOll &28tD$f20tl

The Institutional Ethics Committee reviewed and discussed your application to conrProtocol entitled, *Protocol no: CP/13/10: A Multicentre, prospectivC, open r,abel Sllf"ty and Efficacy of Letnozole as Adjuvant Theetment of Post- Meno[ausat WomIfomone Receptor Earty Brcast Cancer."

The following documents were reviewed:

] I 'NTERt20 254201

I ad SOPs pera ICMR2006,particulr; and

t they o nwith

)4

u E t \ u 3 d

Sr, No. Documents Name Document details (Version & Datr

I Study Protocol Version I ,Dated 24 Jan20ll

2 lnvestigator's Brochure July 2010

3 Case ReportForm (CRF) Version l,Dated 24 Jan 20ll

4 English India Master Infonrred

Consent

Version I .Dated 04 Feb 20ll

5 India Master Informed Consent-

Version 01 dated 04 Feb 201l-Dr.

Chetan Dilip Deshmukh, Hindi ICF

Version 0l dated 04 Feb 201 I

6 India Master Informed Consent-

Version 0l dated 04 Feb 201l--Dr.

Chetan Dilip Deshmukh, Hindi

Back Translation ICF

Dated 23 Feb 201I

7 India Master Informed Consent-

Version 01 dated 04 Feb 2011-Dr.

Chetan Dilip Deshmukh, Marathi

ICF

Version 01 dated 04 Feb 201 I

L.H. Rwisod :}lft8tol

8 India Master Informed Consent-

Version 0l dated 04 Feb 20ll--Dr.

Chetan Dilip Deshmukh, Hindi

Back Translation ICF

Dated 24 Feb 2011

9 DCGI Marketing Approval Datedz3l07n009

l0 lnsurance Statement Policy no- OG- I 1-1901-3303-00000060 Da

From 18/02/2011 - l7l02l20l2

ed

1 1 lnvestigator undertaking Dated29/03/2011

t2 Curriculum Vitae Frincipal Investigator & Medical Registati

Certificates

n

13 Subject diary Card In English 1

14 Subject diary Card In English 2

l 5 Subject diary Card In English 3

l 6 Subject diary Card In English 4

t 7 Subject diary Card In Hindi I Translated From English to Hindi 24 Feb 2 1 l

tB I suu.lectdiaryCardlnHindi 2 lTranslatedFromEnglishtoHindi24Febit l

l l

t9 Subject diary Card In Hindi 3 Translated From English to Hindi 24 Feb ) l t

20 Subject diary Card In Hindi 4 Translated From English to Hindi 24 Feb 0 l l

2 l Subject diary Card In Marathi 1 Translated From English to Mararhi 23 Fe r 2011

Translated From English to Marathi 23 Fer 20 l l22 Subject diary Card In Marathi 2

23 Subject diary Card In Marathi 3 Translated From English to Marathi 23 Ft r 20l l

24 Subject diary Card In Marathi 4 Translated From English to Marathi 23 Fr b 20 l l

3ll05n01125 Refenal Letter

The IEC approves the above documents to be conducted in its presented forrn except ICrequested to make the necessary changes in the ICF as per IEC suggestions

The following members of the Institutional Ethics Committee were present at the meetingJune 2011 at 3.00 pm at Deenanath Mangeshkar Hospital and Research Centre.

You are

I on 16fr

1 Dr. Ushatai Khire Ph.D. Chairperson

2 Dr. Jitendra Deuskar M.S. Clinician

aJ Dr. B. Y. Pawar M.D.IDCC Basic Medic:I Scientist

4 Dr. Ashwini Joshi DNB (Medicine), MNAMS Basic Medici Scientist

5 Dr. Prema Shidore M.D. Pharmacolory Pharmacolog st

6 Dr. Sujala Watve B.Sc.,M.A., Ph.D Ethicist

7 Adv. Sheel Rege B.A..L.L.B. Legal Expert

8 Mrs. Aaratee Gadkari M.Sc. (Microbiolory) Lay person

9 Mrs. Prajakta Kanitkar B.Sc. Industrial Chemistrv Lay person

10Col.J.C.Pendse, VSM (Retd.) B.A. (Hons)

Member Secr)tary

Please note that the Principal Investigator was invited to explain the protocol. He/She an<study staffmembers did not participate in the decision making / voting procedures.

The Institutional Ethics Committee expects (i) you to abide by Privacy and Confidentialityinformed about the progress of the study, (iii) to be informed about any SAE occurring inof the study, (iv) to be informed about any changes in the protocol and patient informatiorconsent and (v) to be provided with a copy of the final report.

Please be informed that the approval for a clinical trial protocol starts from the date of this lefor duration of two years or for the stipulated duration, whichever is less, unless specifiedIn case of approval for any other study related documenUs, approval would start from the dletter and is effective only tiil the basic protocol approval rernains valid. In case the sttcompleted within this time frame, an application should be made for renewing the approrstudy at least two months prior to the end of appro@{.

Yours-TT",, l6frjjJffi

fc lu"J* \\A {f*ll, )fl}Il _--' \\/ \uen&e -/:f //

Col J.C.ItFlds6VSM (Retd.) \ Y '",//

;i";;;ffi;.i,mc-nnmcnc, \=/ Dateorlssue' ?\r'\tnDeenanath Mangeshkar Hospital & Research Centre

or other

(ii) to bere courseinformed

'and isrwise.of thisis not

for the