Оценка на документацията за многоцентрови клинични изпитвания .

1. OqeH
no ETHKA 3A MHOrOL|EHTPOBH
CraHflapxHa oneparneHa npoueAypa N° 07
fl0KyMeHTaL|M3 33 KJ1HHMMHO M3nMTB3He C
fl-p AneKcand
npedcedame.
MHO8OU,eHm
no emuKa sa
"*S I L
dupeKmop,
no
OUEHKA HA ^OKVMEHTAUim 3A KJIHHHMIIO IOIIMTBAHE cx-
na npoue^ypaxa e aa ce onpeflejiH peatx 3a ouenKa na
nocxtnHJio HOBO 3ajiBJieHHe 3a KJIHHHHHO H3HHXBaHe.
2.O6xBaiua BCHHKH KJIHHHHHH H3HHXBaHHH, npe^cxaBenH 3a cxaHOBHiue na
3.OrroBopHocTTa no H3ntjiHeHHexo e na npeace^axejifl, HJienoBexe, H
eKcnepxH KtM KoMHCHJixa.
na
no
, Heo6xoamviH 3
COn_07_4)opMyjuip_02_Ocenka
1 Checklist
S.Hop.MariiBHH aKTOBe HAOKyivieHTH, n3noji3Bann 3a ujroTBHuero na ra3H COn
5.1.Hape,a6a31,o6H. flB, 6p. 67 ox 17. 8. 2007 r.,
5.1.1. IlpHjio>KeHHe 1 - npHHunnnxe na /JoOpaxa KjiHHHHHa RpaKXHKa (/],Kn)
6.1.
6.2.
KoMHCHHxa no exHKa 3a MHorouenxpOBH HsnnxBaHHJi CJIC/IH 3a najiHHne H
ci.oxBexcxBHe na npejacxasenaxa ^OKyMCHxauna c H3HCKBaHHHxa na Hape/i6a JY"
3 1 H ocxanajiHxe HopMaxHBHH ai<xoBe, perjiaMCHXHpamH peaa H ycjiOBHaxa 3a
H3Bi.piuBaHe na KJIHHHHHH H3nnxBaHHM B P. Bx.jirapH» Kaxo H3BX,pniBa oueHKa
na ntjiHoxaxa H ctoxBexcxBHexo na saaBJieHHaxa H npeacxaBenaxa
^OKyivieHxauHa, Ha Haynnnxe, Me^HUHHCKnxe H exHHHHxe acneKXH na
H3nHXBaH6XO.
Cjiezi nocxtHBane na sajiBJieHnexo KoMCHH^xa Ha CBOC 3aceaanHe onpe^ejia:
1.2.1. EKcnepx c ropH^nnecKO oGpasosaHHe - xexHHnecKH cvrpyiiHHK HJIH HJICH
Ha KoMHcnaxa, KOHXO ^a H3Bx.pniH oueHKaxa Ha numoxaxa Ha aoKyMenxauHaxa
H ctoxBexcxBHe Ha saHEjiennexo H npeflcxaBenaxa ^OKyMenxaizHa c
HOpiviaxHBHHxe aKXOBe (COn_07_({)OpMyji5ip_01_Check_list) B onpe^ejien ox
KOMHCHHxa cpoK, KOHXO He M0>i<e fla 6tae HO-^tJitr ox !/2 ox onpe^ejieHHa ox
3HHXM cpoK 3a npoH3HacHHe Ha KOMHCHHxa.
1.2.2. PeueH3eHX ox cx>cxaBa H HJIH BbHmeH peueH3CHX, KOHXO fla HSFOTBH
cxaHOBHUj,e no oGpaseu OXHOCHO Haynnaxa, Me^HUHHCKaxa H exHHHa ouenKa Ha
H3HHXBaHeXO B OnpeaejICH OX KOMHCHflXa CpOK, KOHXO HC MO>K6 Ra 6x>JJ,C HO-
ox !/2 ox onpe^ejieHHa ox 3JIHXM cpoK 3a npOH3HacaHe na KOMncnaxa.
Jlnuaxa no x. 1.2.1. H 1.2.2. nnc^opMnpax ceKpexapa na KOMncnaxa
Ha paSoxaxa CHH npeacxBJix cxanoBHuiaxa CH. B cjiynafi, ne
con 07
S/Hoewiepn 2014
cjp.1 or 6

2. 9J-0 2'i
HOZ ndai/iaoH/e
ZOUOO
a 3HB8KaoHBX3£<ia HUH sHnsxsniEsgo oxoH3tTHatT3du BH
!3XHUHHXOBhK BH 3HBdHOH3UlVO>I BLTsd H BITH8 'BW9QO BH BMH9HQ
^HUiroaodgotT amaedtre BH oxsHBnxBiniEE BH oxsHHSirsrrsduEBd
H Bd3W£Bd OHIT3XHhOXLT>I3 '3HBaXMU£H OXOHhHHHLO) 3 3XHHHHX3Bh/(
BH 3HH3X3LH£3gO HUH 3HH3ir>KBdjBII£cia BE BLTsd H BXKH3OU3A BH BMH3HQ
XBLTBLT BIT HHgOOOUD9H 'BtTHlf BH SHBahOXUMa OH SXHdAlTsHodu BH BMH9HQ •
iHlTBHdgXBW HHWBITM9d
'HHHHXDBHA BH SHBdugBH B£ BlTgd H BXKuaoiroX BH BMHSHQ •
!9HOBirjq,o OHBdnwdo^HH Be
H BXH9HHBU Be BXKHHBWdO({)HpJ BH OX9HHB>KdllTlO BH BMH3HQ •
iHHHBlT HHhHHHIT>ILT9du
H HHhHHHLfM 3XHHRHKBH H KIT9XBaOtT9ITOeH BH BXBdAmodg BH BMH3UQ •
^BLTCDIOXOdu BH BMH9HQ •
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H BHShogirifBe 3 OISHBHIHUCH BH BMHgno BHBHXS H BXBMDHHnHLTsw 'BXBHhXBH
•3HBaXHH£H OXOHhHHHlTH
BH BXKHIlBXH3wX>IOtT W1M BJBITHdu 30 BXH3EH3tT3d BH StHHaOHBXO OH3WDHIJ
OXOHBOHIJlTOU 'OX9HBaXHU£H BE BXKHOHWO>J BH 9TnU30HBXO BH SHBaBtTEH LT3IQ
'BHHlTOJ BH1T9 XO CDHTBW-OII HL"Gacl3XHH BH OX9HBahXodu
BH B09dxodu BE HlTBITMOlT BH 9IIKaBXOlT3du 9 HIT OWHLTOXg09H - OX9HBahXodu BH
BffOX BH dOEtTBH EHlnXMSX BE BXH9eH3H9d BH BM^dougdu BahOlLfMa OX9tHHaOHBX3
'SHBaXHUEH OHhHHHITM OXOH3>KOIfLT3du
Hdu 33O>tOHd 9XHWHlTHaLT3du HIT XB3BlTaBduO OX9HBaEBU098BdlTE BE
9XHEITOU H HXH9HHBLT 9XHXTT9lTT,g H 9XHniKOXOBH BE 'OXSHBaXHUEH 3 3XHHHHXOBhA
Be Heirou HHhHxasuBdax 3XHHBa>iBho - sarorond H Heirou gxHHBaNBho
BH OXaHHOmOHXOlO BH BMH3ITO BHI^XBUndxC HUHBH1T3XH>KO1TOU BHlfSXBhHOMO -
3HH3hCHITMBe 04,0 Bamd'LaEE OXKOM 'BMH3HO BHhHXHd>I XBamdiaEH 3XHXH3EH3H3J
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Xqj,H3EH3H3d OX3HHBLT30BE BH KH3IT Q •OXOLTTHaOHBXO KT.M OKHOOHXO OX3HH31T3KBE
BH OX3HBtT>K3irj£Bd OHShOIIIMa 3 TT3d H3a3HtT OXHHh a OX3HHB1T30BE BH BXBXBlT
HHlT Hdx XO OH01M OU 3H 'BXKHOHWOM 3 HUHHXOBhA HMHH09 BH OHSXBdUEH
BIT BE 'dBX3d>I30 KHH3BIJX HlfH MHHlTXdxa.O KHM03HHHX3X BH ITH3W OH
BlHBduEH 30 OXOnTJQ '3HBaXHUEH OHhHHHITM BH BMH3HO BE HXH3W3IT3 3XHH30HOO
toBJKdilTio '(B>[U30O~20~dKirXwdo(|)~/_o~LJO3) BXKHOHWO^ BH dKirXwdo(|)
HSXdBlTHBXO 3 K3BXOLT3du 30 H OH9WOHU 3 BXH3£H3U3d BH
BXH3EH3H3d BH 91HH30HBX3 '£'9
BXBWHLTOXgO3H BH SHKaXOlTsdu OlT 3H9X BIT BdHUO X1>IOd3 "OWOHU 0
KITSXHaKBE BdHWdO(|)HH BXKHOHWO>J OX 'dSXMBdBX HSaHXBdxOHHHWtTB 0 H>!OXuodu
HH39OHBXOyC BIMH BXEHnBXHSwXMOtT BH BXBXOHIfXU BH BMH3L10 BXBHSmdiaEH
MHaaxodBxau o aHsaxMusn OHHUHULTX BS Ki/ihEXHaiAiANOtf BH e»H8ho 'ZO °N UOO
HaOdlH3nOJOHIAl V£ VMI/I13 OU

3. KOMUCHfl no ETHKA 3A MHOTOMEHTPOBM HSnMTBAHl/m
COn N° 07: OqeHKa Ha flOKyMeHTaqufl aa KnuHMHHO nannxsaHe c neKapcxseHu npoflyxrn
na Bpean HJIH iia cMtpx, nacxtrnijin npn HJIH no HOBOZI ynacxHexo B
KJ1HHHHHOXO IBriMXBane;
• OueHKa Ha rjiauHHfl H3cjie:jOBaxeji, H3CJie,iioBaxejicKHH eKHn H
H3ncKBaHHxe no npoxoKOJi ycJioBHfl H oGopy/iBaHe;
• OueHKa Ha 3acxpaxoBi<axa. noKpHBama oxroBOpnocTTa na
H3CJie^oBaxeji H
6.4.1 . OueHKaxa Ha npoxoKona
noTBtp>K,fl(aBane Ha H,neHXH(pHKaropHxe na H3nHXBanexo (xeivia,
xa; BX.3Jio>KHxejr);
HCHO H no^poGno JIH e onncano npoy-iBaHCTO B npoxoKona;
oueHKa Ha naynnaxa CXOHHOCX na npoeKxa - IIPHJIO/KHMOCT Ha flnsaHHa KX.M
nocoMCHMxe 3aaaHnxe M nen na npoy-iBanexo; BSCXH JIH ca npeaBn^
ny6jiHKyBariHxe ox EK H EMEA nayqnn px^KOBo^cxBaxa 3a npoBe>ic^aHe na
K.1HHHHHH H3HHXBailH5I B C'bOXBeXHaxa H030,10rHHHa CZIHHHUa, CtFJiaCHO
Mji.84,aji.2o-r3JinXM:
Kpnxepnn 3a BKJiioHBaHe H H3KJiioHBane na VHacxnum-i;
KpnxepHH 3a npei<pax>iBane Ha ynacxHexo B npoy-iBanexo;
npouejiypn no npoyHBanexo - PHCKOBC, GonKa H zwcKOMCpopx, cB-bpsann c
HsriHXBanexo;
jieneHHe na yiacxHnnnxe (najninne na HHCXO njiaueGo paMo n Mepi<n 3a
Konxpoji na saGojiflBanexo B nepHO/jnxe na npnjio^KeHne na njiaueGo -
oGocHOBanocx na cpoica, Bi>3MO>KHOcxH 3a noam.p>i<ama xepanna, necxoxa na
n Ap.nperjiejjH sa npeuenKa BjiomaBane OCHOBHOXO saGonaBane)
i-ia KpnxepHHxe H cpOKOBexe sa oueni<a na ecpeKTHBHOCTxa H
cpoKoeexe 3a oneiiKa (B saBiici-iMocx ox noiaoanuMxa - ecxecxBen xo/i na
3aooji>iBaHexo, xnn H xapaKxep na /icncxBHexo na irsnnxBanna npoziyKx);
KpnxepnH 3a ouenKa na 6e3onacnocxxa na HsnnxBaiiMH npoayKx;
cxaxiicxHiieci<a oGocnoBKa na H3i'inxBanexo (Gpon njianHpaiin naunenxn,
KpuxepiiH 3a ecpeKXHBiiocx H Gesonacnocx);
xepaneBxnnnH noji3H 3a ynacxunnnxe B n3imxBanexo, 3a nacxoamnxe
H GvieinHTe naunenxii H noji3Hxe 3a 3/ipaBeona3BaHexo;
I-UIHHH 3a rapanxnpane (])H3HHeci<axa H ncnxHHecKaxa nenpnKocnoBeHOCx na
yiacTHHKa B
3a rapanxnpane na npasoxo na HenpHKOCHOBenocx na JIHMHHH >KHBOX H
npasoxo Ha samnxa Ha JIHHHHXC jianHH na ynacxuHKa;
6.4.2. OueHKaxa na 6pouiypaxa na H3CJiezioBaxejiM BionoMBa:
oueHKa 3a aicryajmocx na Hii^opMamiMxa (nocjie^naxa BepCHH xpaGsa ^a e
H3iiazieHa npejin ne noBeiie ox 1 ro^iina ox no,xaBanexo naflOKyMenxauHHxa
HJin jja ce ctntxcxBa ox ijoKyMenx. y,aocxoBep>iBam, Lie HMMQ HOBH ^annn 33
con 07
Bepcufl 3/HoeMBpn 2014
cxp.3 016

4. gio f 'dio
ndai/iaoH/£ bsnodag
ZOUOO
'WXLJlf£ 10 10 1 'lfh H 001 'Uh '86 'Uh 'Z.6 'Uh '96 -i
o '9H3Birjq.3 xBtrctf Gt/ Hngo3ou39H oHH9wgda 'Gniiir 'HHiairoirew /
'HHgo3OU399tr3H - 9H3Birx4.3 OHEdHwdocpHH xGtTGtr Gtr HHQOOOIIOSH BHHIT
9HBaXHUEH OXOHhHHHLfM GH OX3HGff>K3aodu 3 HIT OHGdlIXH3W,-(xdG G3KH3nO BXKH3HKO>I
HUAdj
BH 9HXOGhX H HXH3HHGU GH SHGdHgGH G£ 9XHdXtT9nodu GH GMH9nQ 'W9
•9XHXH9HHBU BH
r. HLTH/H BxxooHOGiioe.og H Gxcasdu BII sHBaf^iroe ur. 3HH3hBHe BIVH sHiisiiir^uotr
BOOX OXBXOM 'BMHXMBdu BHhHHHL'M ndgo^/ U£. BXBIi"H{TGd]J[ J.O Ql'8't7 '^ a B1BHCOH1IO XO
3H330U BH O.I.3HKaBJ,3r/3dlI GMOH^H Gf 3>KOIV BXKHDHI'O>I GMHSHsdll K03D O[]
XMBXHOM BE 9XHHIIBC' H 9HH1T OWHDHaB£9H 3 XMBXHOM B£ gXHUHBtf GH
!9HH9h9IT H H>KHdx HnTSl/ig K9H/OX9H G£ 3XHHBXBKOU GH
93 T3V B3OX E9g H B3OX BE KHH9HDKgO B3B1? BtT E9g '3JAI3da OMK33 OU OX3HBalT9ir3EH
XO HKJ3XXO 93 VV H9tfOgOa3 9 XaXHSHTlBU 3h 'KHTlBlMdO(|)HH BH OX3HhHIH3H
BagKdx OH3iT9r/9du£^d 9ircig sm OXSHGIHGITU OXHOM ou "X'LHHhBH)
H SHBHIBITUBE BH ITOX91M 'oaX39hHITOM 'ITMa
9XHaBdfE BH OXSHBTXIBITUBE GH 9HH3mOHXO OU KMUBWdoCpHH BH 3HB3KEBdxO
!OX3HB3XHUEH
XO HX9Tn BH HBhXlfD 3 3XHHnB3H3IHVO>I BE KHHGlvdo(f)HH BH OXSHhHirGH
sxi-maHEGami BH Gtrna H BXGXOXDSI,
OII30030 'BL'OMOXOdu XO Hi;HB.I.3tr HH.M'.Ga !1>[hlI33 GXKHriBIvdO(j)HH HL^ B^d-XCT^
:B>IHE3 GH BXX3OHU1X3O1T
iBMHXMBdu
BHhHHHITM Bdgojj' BE BXBITH3Bdu XO OI'8't7'x " KHHB3M3HEH 9XHH3HXBWdOH
XO HHSKSfsduO '3H3BITJS.3 BH HXH3W3IT9 HMHH33 HH9hOlir>I3 B3 HITBtT
:Bai<H3n3du 93
OHGdHWdO([)HH BE dKL"Xwclo({) H BXH3HTIBU B£ KHHGwdO(|)H]/I BH GMH9UO HdjJ '£'t?'9
•dtT H HHHMGSd HHB1T9MOH BE 9HB3KtT9I/3Odu
T3H dSXMBdBX H BXOX33h 'X>lXfOdu KHHBalTSirSEH BH 3HBC'>K3acia BH X1U
'WH>K9d aOEOtT OX9HG3XHUEH a KHH9>KOlTtr9du HIT XBdHXHSwXxdG HHHBf 9XHHB3HUO
KHHB3XHUEH GH lIH({)Odu
KHHHhHHHITM H GXG>IHX9HH>IOMGtdC(|) "(WXLJLTC lo C'11"^ '68'lrh "t'MHXMBdll
BHdoXBdoOBII BXBdgo'17' BH lUKHHCa>IOHS.H 3 9H3X3X33XOq.3 3 KHHB3h/(odu
HHhHJOirOMH3MOX-OHIiHJOL'0>IBIvdB(]) GO HL" HH9f3aodu) GXKHJOL'OMHOMOX
'BXKHJOIfOMBWdBCp :HMHX3Hd3XMBdBX HIIhUXagllBwdBCJ) H 3XHHHHWHX BH 9HHG3HUO
OHgodtTOU BH 9HhHI/BH - HHHBTT HHhHHHITM H HHhHHHLTM9H 9XHHHHITBH GHGMH9UO
XBXBITBH Bf OXHOM 'l/OHd9U H9mHl3'OJOHf3 KHHf3IT3OU
o aHEaxnuen OHHUHHUM Be BuhEXHaiAiAxob1 BH BMHahQ ^ZO °N UOO
M9OdlH3hOJOH^ VS VMM13 OU BUOMIAIOX

5. no ETMKA 3A MHOTOUEHTPOBH
COn N° 07: OueHKa na flOKyMeHTaunn aa KJIUHUHHO nsnuxeane c neKapcxeenn
Koraxo 3a npoBe>K^aHexo na ne-xepaneBXHHHO H3HHXBane e HeoGxo^HMO ctrjiacnexo
na 3aKOH6H npe,acxaBHxeji Ha ynacxHHKa HJIH npoxoKOJitx na KJIHHHHHO H3nHXBane
nosBOJiHBa BKjitOHBane Ha nauneHX, 6e3 ,aa e B^SMOKHO Herosoxo Henocpe^cxBeHo
nncMeiio ctrjiacne HJIH ctrjiacnexo na HeroBna saKoneH npe/icxaBHxeji, KoMHCHsnra ce
npoHsnacfl no Btnpoca, ziajin npeAJio>KeHHHX npoxoKon H/HJIH zipyrH ^OKyivieHXH
cibBnaziax c exn^nnxe nopMH, cnope^ npaBHiiaxa 3a Ro6pa KjiHHHHHa npaKXHKa H
JI,eKjiapauHHxa ox XCJISHHKH, H .najin oxroBapax Ha npHjio>KHMHxe nopMaxHBHH
H3HCKBaHHfl 33 XaKtB XHH H3nHXBaHHfl (3J1E[XM H 3aKOH 3a 3ApaBCXO, KoHBCHUHfl 33
3am,Hxa npasaxa na HOBCKa H HOBemKoxo AOCXOHHCXBO BX>B Bpt3Ka c npHjiaranexo Ha
nocxH>KeHHaxa na GHOJiornaxa H
6.4.5. OuenKaxa na ycJioBnaxa H pe^a 3a Bt.3Harpa>i<fleHHe HJIH oGesmexeHHe Ha
yHacxHHHHxe B KJIHHHHHOXO H3nHXBane,
pasMepa na sanjiamaHexo na 3^paBHxe
paanpe^ejieHHexo na 3anjiamaHexo Ha sapaBHxe
rapanxnpaHO nponopuHOHajino Ha ynacxnexo BtB Bpeiviexo
jiHnca na (J)HHaHCOBn cxHMyjiH 3a npoatJi>KaBamo ynacxne npn >KejiaHne na
y-iacxHHKa aa ce OXXCFJIH;
oueHKa AajiH Bt3Harpa>K^eHHexo oxpasasa peanno peniviGypcHpaHe 3a BpeMexo,
ycnjiHaxa H paBxoanxe HM, HJIH cyMaxa e no-3HaLiHxejiHa H MOKC
npe^y6efleHo noBJinaBane na H3CJieziBaHHxe m ynacxBax;
H pea 3a Bt3cxaHOBflBaHe na pa3xo/iH;
rapaHXHpano 3ana3Bane Ha npasaxa na 3acxpaxoBaxejiHO noKpHXHe,
ox nojiynaBaHoxo sanjiamane 3a ynacxnexo.
6.4.6. OueHKaxa na rjiaBHna H3CJie^OBaxeji n H3CJie^,OBaxejiCKHa CKHH BKJiiOHBa:
CnajBane na HSHCKBanexo HaHji.86, an.2 ox 3J1EIXM - KjiHHHHHa cneimanHocx
B ctoxBexnaxa oGnacx;
cnasBanexo na H3HCKBaHexo Ha MJi.86, an.l ox 3J1F1XM
O BT>3MO>KHOCX Ha CKHHa Ra H3BtpmBa CneUHCJ)HHHH
jiene6HH npoue^ypH, cstpsaHH c
o OHHX B npOBOKAanexo Ha KJIHHHHHH H3HHXBaHHH (ycxaHOBCH c
no MJi.6, an.l x.3 ox Hape^6a JV»31);
o nojiyHeno JIHe ct-rjiacnexo na ptKOBo^Hxejia na jiene6Hoxo saBe^eHHe, B
Koexo me ce npoBe>K,aa KJIHHHHHOXO H3nnxBaHe, ctrjiacno HJi.87 an.2;
o HanHHHe Ha cneunanHCXH c ^pyrH npoc})HJiHH cneunanHOcxH (H3Bi>H
OCHOBHOXO 3a6oJIHBaH6, 33 KOCTO C6 HSFIHXBa npOflyKXa) npH H3B6CXHH
cneun(J)HHHH HOicejiaHH peaKunn, nanaramH npocjieaHBane B xo^a na
npoyHBanexo.
6.4.7. KoMHCHflxa no exHKa ^asa oueHKa na Heo6xo,UHMHxe ycjiOBHH H oGopyztBane 3a
H3ntJiHeHHe Ha npoxoKOJia:
con 07
3/HoewiBpn 2014
crp.5 or6

6. KOMMCMfl no ETMKA 3A MHOrOMEHTPOBH l/ISFlHTBAHUfl
COD N° 07: OMeHKa HaflOKyivieHxaMHE3a K/IUHUHHO nannreaHe c neKapcreeHu npo,qyKxn
Cna3Bane Ha HSHCKBaHnaxa Ha HJi.87, an.l OT3JIFIXM;
HaJIHHHC Ha HCO6XO/1HMOTO XCXKHHCCKO o6opyABaH6 3a H3HX,JIHeHHe Ha
npOTOKOJia - aKpeflHxnpaHH JiOKanHH / ueHipajiHH jia6opaxopHH, .npyni
xexHHHecKH ctopDKeHHfl c HeoGxoflHMaxa cnopejj npoxoKona cneuH(})HKauH5i
(5IMP, KAT, cneuH(]}HHHM MCTOAH Ha H3CJie^BaHe); npn H3non3BaHe na
xexHHHecKO o6opy,n,BaHe - onepaxHBHOcx H yflo6cxBo 3a
; ype/inxe, cJ)yHKUHOHHpaiHH c HSXOHHHUH na HOHH3Hpaiij,H
aa pasnonarax etc ctoxBexHH axxyannH JIHHCHSHH, HSAa^eHH ox
3a HApeno peryjinpaHe.
Bt3Mo>i<HOCT 3a npoBOK^aHc Ha cneuiHH peaHHiviauHOHHH MeponpHaxHH (B
ox noi<a3aHii>ixa H (J)a3axa i-ia pa3Bnxne na
oueHKaxa Ha ycjioeHflxa 3a HsntJineHHe Ha npoei<xa ce npaBH 3a BCCKH ox
npezi,Jio>i<eHHxe uenxpoBe.
6.4.8. OueHKaxa na 3acxpaxoBi<axa BKjiiOHsa
noKpHBane Ha oxroBopnocxxa na Bi>3Jio>KHxejia H rjiaBiiHH/xe
oueHKa na npe^BHaeiioxo HH^HBHayajiHO H arperaxHo noi-cpHXHe;
ycjioBnaxa 3a noflHOBMBane na 3acxpaxoBi<axa;
cpoKOBexe na HOKPHXHCXO;
cpoKOBexe H ycnoBHJixa sa npe^iB^BaHe na HCKose ox
(o6ocHOBaHH JIH ca cnpaMo onaKBanaxa npo/n>ji>KHxejiHocx na npoyMBanexo,
xapaxxepa H MexaHH3Ma na ACHCXBHe na HSHHXBaHHH neKapcxBCH npo^yKx);
HannHHe/jinnca B o6m,Hxe ycnoBHJi Ha H3HCKBanHJi, KOHXO npoxHBOpenax na
BKJTK)LIBaiHHXe H
6.4.9. OueHKaxa Ha ycjioBHHxa H pezia 3a Bt3Harpa>KaeHHe HUH oGesmexenne na
B KJIMHHHHOXO H3iiHXBaHe
JiHnca na 4)HnaHCOBH cxHMyjiH 3a npozitJi>KaBaHe na ynacxnexo na nauneux
(Hanp.sannaiuaHe 3a nauweHX "sae-bpiuHJi" npoyHBanexo, vs. nponopUHonajiHO
HSlXbJlHCHH BH3HXH) B KJ1HHH4HO H3HHXBaH6;
na BtsHarpa^AeHnexo ne HO/IJIOKH na oxAenna
6.4.10. OueHKaxa na eneivieHxuxe na AoroBOpa Me>K^y Bt3Jio>KHxe;i>i H
Ha Me^nuHHCKHxe rpn^KH 3a ynacxHHUHxe;
H cpOKOBe 3a apxHBHpane Ha AOKyMCHxauHHxa no KJIHHHHHOXO
, aKo e npe/iBHzieHo apxHBMpane ox ueLie6HOxo
3a npeKpaxHBane na aoroBOpnxe - cpOKOBe na
(no3BOJi«Bax JIH npexB-bpiiHHexo na rpn>i<axa PInpocjie^5iBanexo na ynacxHHUHxe
B npoy-iBanexo B apyra ueuxpOBe, ycjiOBHH 3a ctxpaneHHe na
Ha H3CJieflOBaxejia npn npeKpax^iBane Ha zioroBopa c Jiene6HOxo s
con 07
Bepcua S/Hoewepn 2014
crp.6 016