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ҩٴ淶200364վʳƷҩƷල־ͨ跢淶200391ʩС

ҩٴ淶

һ

һ Ϊ֤ҩٴ̹淶ѧɿߵȨ沢䰲ȫݡл񹲺͹ҩƷл񹲺͹ҩƷʵʩչʹԭƶ淶

ڶ ҩٴ淶ٴȫ̵ı׼涨ơ֯ʵʩ顢顢¼ܽͱ档

иٴ顢öȻЧ飬밴淶ִС

Ϊоϡҽѧնԡ¼1˸ʹ̶;ܱ˺

ڶ ٴǰ׼Ҫ Դwww.examda.com

ҩٴгֵĿѧݡڽǰܿǸĿļҪ⣬ӦȨߺ͹ڽԤڵ漰գԤڵӦֵܳ𺦡ѡٴ鷽ϿѧҪ

ٴҩƷ׼ṩٴǰ߱ṩҩٴǰоϣɡ칤պṩٴǰϱϽӦٴҪͬʱӦṩҩɺڽٴйصЧԺͰȫϡٴҩƱӦϡҩƷ淶

ҩٴʩӦ㰲ȫЧؽٴҪо߶Ӧ߱еٴרҵسʸѵٴ鿪ʼǰоߺӦ鷽ļ顢ͱ׼ԼеְֹȴЭ顣

ߵȨ汣 Դwww.examda.com

ڰ ҩٴĹУߵĸȨֵıϣȷĿѧԺͿɿԡߵȨ桢ȫͽڶԿѧĿǡίԱ֪ͬDZȨҪʩ

ھ ΪȷٴߵȨ棬ίԱᣬʳƷҩƷලֱίԱӦдҽҩרҵԱҽҩרҵԱרҼλԱɣвͬԱίԱίԱɺ͹ӦκβߵӰ졣

ʮ 鷽辭ίԱͬⲢǩ׼󷽿ʵʩڼ䣬鷽κ޸ľӦίԱ׼зز¼ӦʱίԱᱨ档

ʮһ ίԱٴ鷽ӦۺͶƱʽٴίԱӦرܡҪίԱרҳϯ飬ͶƱίԱӦл鼰Ӧ¼¼ٴꡣ

ʮ ίԱӦӱȨĽǶϸи鷽 Դ

һоߵʸ񡢾顢Ƿгֵʱμٴ飬Ա䱸豸ǷҪ

鷽Ƿֿԭ򣬰оĿġ߼Աܵķպ漰ƵĿѧԣ

ѡķߣ໤ˡˣṩйرϢǷ׶ȡ֪ͬķǷʵ

ģμٴܵʱƺ/մʩ

壩鷽Ƿɽܣ

ٴߵķճ̶ȡ Դȫվ(wwwExamdacom)

ʮ ίԱӵӦʱٿ飬ۣǩϯίԱרҵǩίԱǣ

һͬ⣻

Ҫͬ⣻

ͬ⣻

ģֹͣ׼顣

ʮ о߻ָĴ˵йٴϸ

һ߲μӦԸģȨκν׶ʱ˳⵽ӻ򱨸ҽƴȨ治ܵӰ죻

ʹ˽⣬μ鼰еĸϾܡҪʱҩƷලšίԱߣ涨ԲIJμϣ

ĿġĹޡԤڿܵͷգ֪߿ܱ䵽IJͬ

ģֵ߳ʱԱ㿼ǷԸμ飬ͬߣӦ䷨ṩ˵֪ͬӦ߻򷨶Ժ֣ڼ䣬߿ʱ˽йصϢϣ

壩緢صʱ߿ԻƺӦIJ ԴŮ༭

ʮ ֺϸ֪ͬ飺

һ߻䷨֪ͬǩֲעڣ̵ִ֪ͬоҲ֪ͬǩڣ

ΪߣίԱԭͬ⡢оΪ߲μ䱾ʱЩҲԽ飬ͬʱӦ䷨໤ͬⲢǩעڣ

ͯΪߣ䷨໤˵֪ͬⲢǩ֪ͬ飬ͯͬμоľʱ䱾ͬ⣻

ģڽ£޷ȡñ˼Ϸ˵֪ͬ飬ȱѱ֤ʵЧƷҩָᲡʹɿΪߣҪ鷽йļ˵ЩߵķȡίԱͬ⣻

壩緢漰ҩҪ뽫֪ͬ޸ίԱ׼ٴȡͬ⡣

鷽

ʮ ٴ鿪ʼǰӦƶ鷽÷Ӧо߹̶ͬǩ֣ίԱʵʩ

ʮ ٴ鷽Ӧݣ

һĿ

Ŀģ鱳ٴǰоٴķֺйصٴ֪ĿΣ棬ҩֲĿܣ

ߵƺ͵ַijоߵʸ͵ַ

ģƵͣ鷽äˮƽ

壩ߵѡ׼ų׼޳׼ѡߵIJ裬߷ķ

ͳѧԭҪﵽԤĿIJ

ߣҩƷļ͡ҩ;ҩҩƳ̺йغϲҩĹ涨Լ԰װͱǩ˵

ˣٴʵҼĿⶨĴҩѧȣ

ţҩƷĵǼʹü¼ַ͡ʽ

ʮٴ۲졢úͱ֤ԵĴʩ

ʮһֹٴı׼ٴĹ涨 Դ̳

ʮЧ׼ķ۲ʱ䡢¼

ʮߵı롢ֱı

ʮģ¼ļ¼Ҫز¼ı淽ʩõķʽʱת飻

ʮ壩ҩƷĽͱ棬äͽäĹ涨

ʮͳƷƻͳƷݼĶѡ

ʮߣݹݿԴԵĹ涨

ʮˣٴ֤

ʮţصѧ

ʮٴԤڵĽȺڣ

ʮһúҽƴʩ

ʮеְйع涨

ʮοס

ʮ ٴУȷҪ԰涨鷽

оߵְ

ʮ ٴоӦ߱

һҽƻоӦרҵְְҽʸ Դȫվ(wwwExamdacom)

鷽Ҫרҵ֪ʶ;飻

ٴ鷽зḻܵõλооѧϵָ

ģϤṩٴйصף

壩Ȩ֧Աʹø豸

ڶʮ о߱ϸĶ˽鷽ݣϸշִС

ڶʮһ оӦ˽ⲢϤҩʡáЧȫԣҩٴǰойϣͬʱҲӦٴڼ䷢ֵҩйصϢ

ڶʮ о߱ҽʩʵ豸Ա䱸ҽƻٴ飬ûӦ߱һʩȷߵİȫʵҼӦ׼ȷɿ

ڶʮ оӦҽƻܵλͬ⣬֤гֵʱڷ涨ڸٴ顣оμٴйԱ˵йϡ涨ְȷ㹻鷽߽ٴ顣

ڶʮ оӦ˵ίԱͬйϸȡ֪ͬ顣

ڶʮ о߸ٴصҽƾ֤ڼֲ¼ʱõʵơ

ڶʮ оȡҪĴʩԱߵİȫ¼ڰٴ緢ز¼оӦ߲ȡʵƴʩͬʱҩƷලššߺίԱᣬڱǩעڡ

ڶʮ оӦ֤ʵ׼ȷʱϷ벡Ͳ

ڶʮ оӦDzļԱԱļͻ鼰ҩƷලŵĻӲ죬ȷٴ

ڶʮ оӦ̶йٴķãںͬдоٴУȡҩķá

ʮ ٴɺо߱дܽᱨ棬ǩעںߡ

ʮһ оֹһٴ֪ͨߡߡίԱҩƷලţɡ

ߵְ

ʮ ߸롢֯ͻһٴ飬ṩ龭ѡ߰ҷɡйع涨ʳƷҩƷලֵݽٴ룬Ҳίкͬоִ֯ٴеijЩ

ʮ ѡٴĻоߣϿʸԱ֤ɡ

ʮ ṩоֲᣬݰҩĻѧҩѧѧҩѧٴģǰĺڽе飩Ϻݡ

ʮ ڻùʳƷҩƷල׼ȡίԱ׼󷽿ɰ֯ٴ顣

ʮ ߡо߹ͬٴ鷽ڷʵʩݹͳƷ桢ķʽȷְ𼰷ֹǩ˫ͬ鷽ͬ

ʮ оṩʶȷ벢ǩҩ׼ƷҩƷο֤ϸҩƷӦ鷽Ҫʵװ档ӦҩƷĹƶȺͼ¼ϵͳ

ʮ ϸļԱΪоܡ

ʮ Ӧٴƺ֤ϵͳ֯ٴĻԱ֤

ʮ ӦоѸоز¼ȡҪĴʩԱ֤ߵİȫȨ棬ʱҩƷලźű棬ͬʱ漰ͬһҩٴоͨ

ʮһ ֹһٴǰ֪ͨоߡίԱ͹ʳƷҩƷල֣ɡ

ʮ ߸ʳƷҩƷලֵݽܽᱨ档

ʮ ӦԲμٴṩգڷص𺦻߳еƵķüӦľòӦоṩ뾭ϵĵҽ¹߳⡣

ʮ о߲׼ķйطٴʱӦָػֲģӦֹо߲μٴ鲢ҩƷලű档

Աְ

ʮ ĿΪ˱֤ٴߵȨܵϣ¼뱨׼ȷ󣬱֤ѭ׼ķйط档

ʮ Աо֮ҪϵˡӵĴȡٴĸӳ̶ȺͲҽƻĿԱӦʵҽѧҩѧרҵѧҪѵϤҩƷйط棬ϤйҩٴǰٴϢԼٴ鷽صļ

ʮ ԱӦѭ׼̣ٴĽУԱ֤ٴ鰴ִСݰ

һǰȷеλѾʵԱ䱸ѵʵ豸ȫתã߱йصļ㹻ߣоԱϤ鷽еҪ

мо߶鷽ִȷǰȡߵ֪ͬ飬˽ߵѡʼĽչ״ȷѡߺϸ

ȷݵļ¼뱨ȷвдȷԭʼһ¡д©Ѹעоǩעڡÿһߵļı䡢Ʊϲҩ䷢ʧá©ȾӦȷϲ¼ʵѡߵ˳ʧڲ˵

ģȷв¼¼ڰز¼ڹ涨ʱ沢¼ڰ

壩ʵҩƷйطйӦءַջأӦļ¼

Эо߽бҪ֪ͨˣ߱ݺͽ

ߣӦʵ¼оδáδе顢δļ飬ԼǷԴ©

ˣÿηӺһ汨ߣӦڡʱ䡢Աķֵȡ

ڰ ¼뱨

ʮ ΪٴԭʼļӦ档еԭʼļԭʼļһ£еκι۲졢Ӧʱ׼ȷ淶ʵؼ¼ڲȷдУģȷдκθʱӦԭ¼ɱ磬ɸǩʱ䡣

ʮ ٴиʵݾӦ¼ԭʼ渴ӡճڲϣΧڵҲӦ¼ƫٴɽܷΧԺʵĿעõļλ

ʮ Ϊ˽ϲӦߵоӦߵĴȷݲ¼

ʮһ ٴܽᱨӦ鷽Ҫһ£

һʵʲ޳IJɣ

ͬĻȽϣȷɱԣ

ЧָͳƷٴͳƽĽӦؿٴ壻

ģȫӦٴ¼ʵָͳƷز¼Ӧϸۣ

壩ЧӦļڵIJ켰Ӱ죻

ҩЧͰȫԼպ֮ĹϵҪۡ

ʮ ٴеϾ밴涨棨¼2оӦٴٴֹꡣӦٴҩﱻ׼кꡣ

ھ ݹͳƷ

ʮ ݹĿڰѸ١뱨棬漰ݹĸֲ¼ڰԱʵʩм顣ʵij֤ݿıԣӦмݿάֳ֧

ʮ ٴ߷밴ȷ䷽УÿߵĴӦΪäߺо߷ֱ𱣴档äӦڷй涨äִнäij򣬲ӦӦżڽ£Ը߽ä˽ܵƣڲɡ

ʮ ٴϵͳƷ̼ıù淶ͳѧٴ׶ξͳѧרҵԱ롣ٴ鷽ͳƷƻʽͳƷǰȷϺϸڷӦ˵ɼ̡õӦĽһǡѡͳƷݼ˵©δû˵ٴͳƱٴܽᱨ

ʮ ҩƷĹ

ʮ ٴҩƷۡ

ʮ ߸ٴҩƷʵİװǩΪٴרá˫äٴУҩҩƷοΡζװǩϾӦһ¡

ʮ ҩƷʹü¼Ӧװˡ͡ܡ䡢ӦúʣҩĻٵȷϢ

ʮ ҩƷʹо߸о߱뱣֤ҩƷڸٴߣ÷Ӧ鷽ʣҩƷ˻ߣר˸𲢼¼ڰҩƷר˹о߲ðҩƷתκηٴμߡ

ʮ ҩƷĹʹáؼʣҩĴӦԱļ顣

ʮһ ֤

ʮһ ߼о߾Ӧиְ𣬲ϸѭٴ鷽ñ׼̣Ա֤ٴƺ֤ϵͳʵʩ

ʮ ٴйй۲ͷֶӦԺʵݴÿһ׶αƣԱ֤׼ȷʵɿ

ʮ ҩƷලš߿ίлԱٴػļϵͳԼ飬Ƿ鷽׼ԼطҪУǷʱʵ׼ȷؼ¼Ӧɲֱ漰ٴԱִС

ʮ ҩƷලӦоʵʩиԵִ״Ӳ졣μٴҽƻʵҵйϼļӦҩƷලŵӲ졣

ʮ

ʮ ɶλо߰ͬһ鷽ڲͬص͵λͬʱеٴ顣ͬڿʼ顣һλҪоܸ𣬲ΪٴļЭоߡ

ʮ ļƻ֯ʵʩҪ¸㣺

һ鷽ɸĵҪо߹ͬ϶ίԱ׼ִУ

ٴ鿪ʼʱеӦ֯о߻飻

ͬڽٴ飻

ģٴСļķӦͳƷҪ

壩֤ڲͬͬҩƷַʹأ

ͬһ鷽ѵμӸоߣ

ߣ׼۷õʵҺٴ۷ӦͳһƣʵҼҲʵҽУ

ˣӦйӦݴݡ˲ѯ

ţ֤о鷽Υʱֹμ顣

ʮ ӦݲμĿҪԼҩƷ˽̶ȽϵͳЭо߸ʵʩ

ʮ

ʮ 淶ĺǣ

ٴ飨ClinicalTrialָκ壨˻򽡿־Ըߣҩϵͳо֤ʵʾҩáӦ/ҩաֲлйĿȷҩЧ밲ȫԡ

鷽ProtocolıۻĿģơ֯ͳѧǡִкɵɲμҪоߡоǩ²עڡ

оֲᣨInvestigatorsBrochureйҩڽоʱеٴٴоϡ

֪ͬ⣨InformedConsentָ߸֪һĸԸȷͬμӸٴḶ́ǩעڵ֪ͬΪļ֤

֪ͬ飨InformedConsentFormÿλ߱ʾԸμijһļ֤о˵ʡĿġܵͷաɹѡõƷԼϡնԡ涨ߵȨȣʹ߳˽ͬ⡣

ίԱᣨEthicsCommitteeҽѧרҵԱרҼҽԱɵĶְ֯Ϊ˲ٴ鷽ǷϺ£Ϊ֮ṩڱ֤ȷߵİȫȨܵίԱɺһлӦٴ֯ʵʩߵĸŻӰ졣

оߣInvestigatorʵʩٴ鲢ٴ߰ȫȨĸߡо߱뾭ʸ飬ٴרҵسʸ

ЭоߣCoordinatingInvestigatorڶٴиЭμӸо߹һоߡ

ߣSponsorһٴ飬Ըͼ鸺Ĺ˾֯

ԱMonitor߸ľ֪߱ʶԱǼͱĽͺʵݡ

飨Auditָɲֱ漰ԱеһϵͳԼ飬ʵʩݵļ¼ͷǷ鷽׼ԼҩٴطҪ

Ӳ죨InspectionҩƷලŶһٴйļʩ¼йٷģӲ鵥λڵػͬо֯ڵؽС

CaseReportFormCRFָ鷽涨ƵһļԼ¼ÿһеݡ

ҩƷInvestigationalProductٴеҩҩƷο

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ز¼SeriousAdverseEventٴзסԺơӳסԺʱ䡢˲СӰ칤Σε¼

׼̣StandardOperatingProcedureSOPΪЧʵʩijһٴÿⶨı׼ϸ̡

äBlinding/Maskingٴʹһ෽֪Ʒij򡣵äָ߲֪˫äָߡоߡԱݷ߾֪Ʒ䡣

ͬо֯ContractResearchOrganizationCROһѧԻҵԵĿѧ߿ίִٴеijЩ񣬴ίб涨

ʮ 淶ɹʳƷҩƷලָ͡

ʮ 淶200391ʩУԭҩƷල199991շġҩƷٴ淶ͬʱֹ

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ҽѧն

ҽѧо׼

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һǰ

1.ҽѧݵĺնԣҽѧо׼ָҽ߽ҽѧоҽѧо屾ݻϵо

2.ٽͱཡҽְҽ֪ʶ͵Ϊһְ

3.ҽѧá˵Ľȿǵ¡ԶҽԼҽѧĹ׼棺ֻڷϲ˵ʱҽſṩܶԲ˵Ӱҽƴʩ

4.ҽѧĽоΪģЩоһ̶Ϊߵ顣

5.ҽѧоУ߽ĿӦڿѧȤ

6.ҽѧоҪĿǸĽԤϺƷ߶Լѧͷʶʹѱ֤ʵ˵õԤϺƷӦϵͨоЧԡЧʡԺ

7.ĿǰҽѧʵҽѧоУԤϺƶзպ͸

8.ҽѧоӦ׼е˼زǵĽȨ档ЩȺȺر𱣻徭úҽϴڲλ˵ҪҪرעЩ֪ܾ֪ͬͬߡв²֪ͬߡоб˵ò߼ͬʱƵߡ

9.о֪߱ڹоɺͷҪ󣬲ҪϹʵҪκιҵɺͷ涼ٻȡж涨ı

ҽѧоĻԭ

10.ҽѧоУߵͽάǵ˽ҽְ

11.ҽѧоձܵĿѧԭ򣬲ڶԿѧ׺ϵȫ˽⼰ֵʵͶ飨бҪ

12.ʵʵʩӰ컷оҪоʵ鶯Ȩ

13.ÿƺʵʩӦ鷽ȷ˵Ӧ鷽ύίԱˡָۡʵ£׼ίԱоߺߣҲκӰ졣ίԱӦڹķɺƶȡίԱȨලе顣оԱίԱύϣеز¼ϡоԱӦίԱύԱйʽߡоԼDZڵͻϡ

14.ойĿǵ˵÷ϱԭ

15.ҽѧоֻרҵʸԱٴҽѧרҵָල½СʼҽѧʸԱ߸𣬶߱˸𣬼ʹѾ֪ͬμӸо

16.ÿҽѧоʼ֮ǰӦ߻ԱԤڷաȡⲢų߲μҽѧооƶӦԻá

17.ҽֻеȷֵܹԤеķղܹϺõشʱܽиоַճܵѾóԵĽۺĽʱҽӦֹͣо

18.ҽѧоֻĿĵҪԳ߱ķպ͸ʱſɽСǽ־ԸʱΪҪ

19.ҽѧоֻȺܹоĽʱܽС

20.߱ԸμӲҶоĿгֵ˽⡣

21.ʼ߱Ȩܲȡʩߵ˽ϵıܲ;Լ˸ӰС

22.κожӦÿλԺѡֵ߳ظ֪оĿġʽԴܵͻоڵооԤڵDZڵķԼֵܳIJʡӦ֪Ȩܾμκʱ˳鲢ҲܵκαȷЩϢҽӦԸ֪ͬ⣬ʽΪˡܵõͬ飬¼ͬĻù̲Ҫм֤

23.ȡоĿ֪ͬʱӦرעҽǷԹϵܱͬμӡ£֪ͬĻӦɳ˽⵫μӴо벢ҲȫϵҽС

24.ڷûʸ״֪ͬ⣬δ˵оߣо߱طɣ䷨ȫȨ֪ͬ⡣ֻиоԴٽȺĽڱ壬ڷʸȺнʱЩ˲ܱо

25.޷ʸߣδͯʵμоľʱо߳õȨ˵ͬ⣬ñ˵ͬ⡣

26.Щоܴߴõͬ⣬ί˻ǰͬ⣬ֻе/״֪ͬȺıҪʱоſɽСӦ鷽вʹμо߲֪ͬԭ򣬲ύίԱ׼л˵ڼоӦ߱˻򷨶Ȩ˴õ֪ͬ⡣

27.ߺͳ̶ҪеΡڷоʱоα֤׼ȷԡԽһԽҲӦʽ֮ڡӦ˵ʽԴоκοܵͻ뱾йԭ򲻷о治ܱ뷢

ҽѧоҽϵĸԭ

28.ҽԽҽѧоҽƴʩϣڸоѱ֤ʵDZڵԤϺƼֵ¡ҽѧоҽƴʩʱΪоҪиԱ

29.·洦աЧԶӦѵԤϺƷԱȡⲢųĿǰûЧԤϺƷڵоУʹðοΪա

30.оʱÿ鲡˶Ӧȷõо֤ʵЧԤϺƷ

31.ҽӦָ֪ܵеһойء˾ܾμоӦӰòҽĹϵ

32.ڶԲ˵Уûѱ֤ԤϺƷʹЧ£ҽжһδ֤ʵµԤϺƷָͼʹ࣬ڻò˵֪ͬǰ£ӦƵӦַڿܵ£ЩӦΪо󣬲мƻ䰲ȫԺЧԡ¼زеõϣʵʱԷͬʱҪѭԵԭ

¼2

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1 оֲ
2 鷽ǩ ԭ
3
4 ֪ͬ ԭ
5 涨
6 ෽Э飨ǩоߡߡͬо֯
7 ίԱ ԭ
8 ίԱԱ ԭ
9 ٴ   ԭ
10 ٴǰʵ   ԭ
11 ʳƷҩƷල ԭ
12 оļ ԭ
13 ٴйصʵҼֵΧ
14 ҽѧʵҲʿ֤ ԭ
15 ҩƷıǩ ԭ
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16 ҩƷʵ˻
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18 ää ԭ
19 ԭ
20 鱨 ԭ

ٴн׶

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22 ļ֪ͬ顢֪ͨĸ
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27 Աӱ ԭ
28 ǩ֪ͬ ԭ
29 ԭʼҽļ ԭ
30 дǩעڣ 渱 ԭ
31 оߵز¼ ԭ
ٴ鱣ļ о
32 ҩƷල֡ίԱز¼ ԭ
33 ڻȱ
34 ߼ϴ ԭ
35 ɸѡѡ
36 ҩƷǼDZ
37 оǩ

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38 ҩ֤
39 ߱Ŀ¼
40 ֤ ԭ
41 ռ鱨 ԭ
42 Ʒä֤ ԭ
43 ɱ棨ίԱ ʳƷҩƷල֣ ԭ
44 ܽᱨ ԭ
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