7
Sach EC-IEC Independent Ethics Corn mittee Konrl NursLn! llorn.. l'un. (' Komal Nu6ing Hone. Mohan*ad'. Alatuli Ro!d. Ncr vishrerwadi Bndge- Yenuada, Sponsor Nrm.: Mercksharp& Dohhc Corp.. a strbsidiary of Mcrck& Co., 1... Pmiool Titl.: An opeirabel. mDxi ccnter tial to evalute rhe [email protected] eflicacy. safdy ad acceprability ora monophAic conbined onl conr6eplive (COCi conr'inins 15 ng noncs.snrmdare (NoMAC) and r.5 ms sradiol(E2) in Indim women Pm.ool Nunb.r: MK-31?5A{17{0ialso kno*. s scH 900121, P07057) sub: f,.bis connlll.. Approv.l ot 6rudy relricd docnndt for Ddr D.. Rsik Morilal shdiyr, This is funher ro your strbmilsion appiovcd thc follorine docunenb dnrins rhe meerinE held on 03/12ll ? ai 07:00 P.M. ' MK-8175A/SCH 90012 r Piolocol d!rd, r 2t April 2012 . ProrNol cldificalion Ler@r dden 76 June 20 r2 . Proi(olNumbd Meno dded2l"June 2012 . MK-3 r ?5A, lnvc{ig&rs Boch!re, dared260April20l2 Bsd on MK3l75A0l7 India M sik Mdirar shcti,s cujad'ircF rndir ModeIcF aulmti r.r 11ocr0r, Konal Nu6ing Hone, P.atiknaBar, Mohanwadi, Near Vish..ntwadi R.idge, Tel 020 2669399. Mobile-+91-9823635563, ICONFIDENTIAL DOCUI.IENT]

Sach EC-IEC · MX-Srr5A-0r? India Dr.RasikMorilal shetila M@ihilcf v.dion I I 16ocr2012 BsedonMK3l75A0l7 IndiaModellCF-Martthi-l.1 lroc!2012 ... Pirl Ae.p'rbiriry Queiionmif vER rnmlaEd

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Page 1: Sach EC-IEC · MX-Srr5A-0r? India Dr.RasikMorilal shetila M@ihilcf v.dion I I 16ocr2012 BsedonMK3l75A0l7 IndiaModellCF-Martthi-l.1 lroc!2012 ... Pirl Ae.p'rbiriry Queiionmif vER rnmlaEd

Sach EC-IECIndependent Ethics Corn mittee

Konrl NursLn! llorn.. l'un. ('

Komal Nu6ing Hone. Mohan*ad'.Alatuli Ro!d. Ncr vishrerwadi Bndge- Yenuada,

Sponsor Nrm.: Mercksharp& Dohhc Corp.. a strbsidiary of Mcrck& Co., 1...

Pmiool Titl.: An opeirabel. mDxi ccnter tial to evalute rhe [email protected] eflicacy. safdyad acceprability ora monophAic conbined onl conr6eplive (COCi conr'inins 15 ngnoncs.snrmdare (NoMAC) and r.5 ms sradiol(E2) in Indim women

Pm.ool Nunb.r: MK-31?5A{17{0ialso kno*. s scH 900121, P07057)

sub: f,.bis connlll.. Approv.l ot 6rudy relricd docnndt for

Ddr D.. Rsik Morilal shdiyr,

This is funher ro your strbmilsionappiovcd thc follorine docunenb dnrins rhe meerinE held on 03/12ll ? ai 07:00 P.M.

' MK-8175A/SCH 90012 r Piolocol d!rd, r 2t April 2012

. ProrNol cldificalion Ler@r dden 76 June 20 r2

. Proi(olNumbd Meno dded2l"June 2012

. MK-3 r ?5A, lnvc{ig&rs Boch!re, dared260April20l2

Bsd on MK3l75A0l7 India M

sik Mdirar shcti,s cujad'ircFrndir ModeIcF aulmti r.r 11ocr0r,

Konal Nu6ing Hone, P.atiknaBar, Mohanwadi, Near Vish..ntwadi R.idge,

Tel 020 2669399. Mobile-+91-9823635563,ICONFIDENTIAL DOCUI.IENT]

Page 2: Sach EC-IEC · MX-Srr5A-0r? India Dr.RasikMorilal shetila M@ihilcf v.dion I I 16ocr2012 BsedonMK3l75A0l7 IndiaModellCF-Martthi-l.1 lroc!2012 ... Pirl Ae.p'rbiriry Queiionmif vER rnmlaEd

Sach EC-lECIndependent Ethics committee

l<,inrrl \LLrsilrit IIonre. l'u'rfri

'ftr:latd fron English b aujaari cn l6 o.r 2012

t MKsl rA4l- Idi, D_ P""rMo'l:l\hch\d Hldik I ve^o ll 6O r)0:B^-."MXsrl.Aoi- IndaMod'll.r Hina' l lrot 0lTnnsla@d rmm Enelish ro Hindi on l6 od 2012

. MX-Srr5A-0r? India Dr.RasikMorilal shetila M@ihilcf v.dion I I 16ocr2012

BsedonMK3l75A0l7 IndiaModellCF-Martthi-l.1 lroc!2012TBnd&d nom Enghn b Madrhi on 16 ocr 201 2

dihr shdF Pbm'medt Gujsd

hdD Modd fhloeostidt r.r cuj,rnNra&d adnEnglkhbcujad'i oi24 sep20r,

B"d}v|'l,|..t0|-m

B;edm M(a'BA{'7 m

rcf tu aujuri. Hiidl

. 20T223Elicibilirycddvl.0lndia(Englnh)loMAYl2

. 207223Bmhucvl.0lndia(Entlhh)r0MAYl2

. 20T22SD.arParienrLetervl 0lndia(English)IoMAYl2

Komal Nursine Home, PraiiknaAar, Mohanwadi, NearVish€.tuadi Bridge,

Tel-020-2669399. Mobile-+91-9423635563,[CONFID€NTIAL DOCUI.4ENT]

Page 3: Sach EC-IEC · MX-Srr5A-0r? India Dr.RasikMorilal shetila M@ihilcf v.dion I I 16ocr2012 BsedonMK3l75A0l7 IndiaModellCF-Martthi-l.1 lroc!2012 ... Pirl Ae.p'rbiriry Queiionmif vER rnmlaEd

Sach EC-IECIndependent Ethics Committee

Kornr \usi !r llor'r.- lf i. 1)

. 20?223Poscrvl.0lndia(EnClhh)10MAYl2

. MK3r75A{r7 subjd'Di4 sool

. MK sr 75A.o r7 (NoMAc.E2) Pir Adprbiliry audioii.iE v.RsroN I roAPRz0r2

! 20? 223 Btuchure v L0 I'dia (HindD 30.Ma] 12

0 hdia(Hiidi)l0 Ma] 12

. 207223Posdvl.0lndia(Hindi)l0Ma'.12

. 207223rhd(YouR.nind$cadvl.0 hdi.(Hindi)-r0May 12

. M Kr r-a-017 subFd Dia.y B

. MK'8 r ?JA 017 (NoMAc-E2) Pilt A&.prabiliry Que$ionmirc vERs'oN I l0'APR l012

Tdnslatdl fnn Etrglish To Hindi on 15 Jui 20 r2

vmion 1.0.3 sep 20os Hindi

. 207223 BrchlE v1.0 India(cujrdD ro.May.l2

t 207223 Der Patienr Lcier v L0 hdia (c0jaiari) 30 May.l2

. 207223 [email protected] lndia (aujrai) ro.May.l2

. 20Tl23ThankYouReniideiC6dvr.0ridia(Cqr€ri)_r0.May l2

. MK3rTsa0rTsubjdDiqBol srard non Ensrrh b cujuii on r 5 ri :01,

. MK,3 r-a-017 OroMAc,E2) Pirl Ae.p'rbiriry Queiionmif vER

rnmlaEd Fom Engrish ro 6ujur on r 5 run r01,

rEEbrd Fron Eqrrh b cujuri on 1r iun 20 r2

tunal Nursiry uon e, Praii knaAar, Mohanwadi, N€arVishrahtwadi Bridge,

Tel-020-2669399. Mobile-+91-9823635563,ICONFIDENTIAL DOCUMENT]

Page 4: Sach EC-IEC · MX-Srr5A-0r? India Dr.RasikMorilal shetila M@ihilcf v.dion I I 16ocr2012 BsedonMK3l75A0l7 IndiaModellCF-Martthi-l.1 lroc!2012 ... Pirl Ae.p'rbiriry Queiionmif vER rnmlaEd

Sach EC-IEClndependent Ethics Committee

K.rrrl N{|\irr! ll!inre. l'rLnc (,

. clinid rri.l ldeniifi@tion c&d vqsbn '

0, 3 s@ 2me cuFBii

. 207223 B@hure v l.0 lndil (Manthi) 30 Mav l2

lndia(M.6!hD r0 Ma) 12

! 207223 Po*er vl.0lndh (MrarhD 30.Mrv l2

. 20T22sThrnkYouRsninddcrdvl 0h'lia(Muarhi) lo.Ma! 1?

. MKsr^a-017 subFd Di,ry B

! MK-sl75A-017(NoM^c-t2)PillAccepbbihqQuenionn.iFvER

rrmslatd Fron tnelish To MaradiOn r5lun 1012.

. DCC I acknowledsene l.n rdar.d22"lune2012

. Eve*ofcrhtd hkE((Ecr)clidameforPornikr DILI (Drug ridu.ed l-iq hj!ry) r

En diee dd. (0l-06.12) Poriq remhdion Dd. (01 06 14)

spein.csA Dr Rasik Morirar sidt! Engrhh D..n

The follosinghhics commitee menbeB *erc presn. durine rhe forementioned mee.in8:I Dr. A R Shdiy4 chairpeBon. s&h Ec.2 Dr. s.K Lodha, vice{hailpcnon. Seh EcL Dr. P.P. Dhok4 Menbq Secdary. Sach trc.4 Dr. v.s. Pandit, M.nb.r. Sach Ec5 Dr. v.A. shilahdr, Menbci S&h EC6. Adv S.P. De*k6. Member. sach Ec.7. Mr. A.

^ Shillhtr Menber, Sachtrc.

9. Mr DS oucr4 Menber, Sach Ec.

Komal NursinS Hom€, Pratikn.gar, Mohanwadi, Near Vish.anlwadi B.idge,

Telo20-2669399, Mobile-+91-9823635563,[CONF1D€NTIAL DOCUI.,IENT]

Page 5: Sach EC-IEC · MX-Srr5A-0r? India Dr.RasikMorilal shetila M@ihilcf v.dion I I 16ocr2012 BsedonMK3l75A0l7 IndiaModellCF-Martthi-l.1 lroc!2012 ... Pirl Ae.p'rbiriry Queiionmif vER rnmlaEd
Page 6: Sach EC-IEC · MX-Srr5A-0r? India Dr.RasikMorilal shetila M@ihilcf v.dion I I 16ocr2012 BsedonMK3l75A0l7 IndiaModellCF-Martthi-l.1 lroc!2012 ... Pirl Ae.p'rbiriry Queiionmif vER rnmlaEd
Page 7: Sach EC-IEC · MX-Srr5A-0r? India Dr.RasikMorilal shetila M@ihilcf v.dion I I 16ocr2012 BsedonMK3l75A0l7 IndiaModellCF-Martthi-l.1 lroc!2012 ... Pirl Ae.p'rbiriry Queiionmif vER rnmlaEd