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Good Clinical Practice (GCP)

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CRA 发表于 2007-1-9 21:01:39 | 显示全部楼层 |阅读模式

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What is GCP?
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GCP is an international ethical and scientific quality standard for the design, conduct and record of research involving humans.
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/ r( J5 E& L0 [, [& \5 UComprised of 13 core principles, GCP applies to all clinical investigations that could affect the safety and well-being of human participants (in particular, clinical trials of medicinal products).& ?; R0 |, N6 M+ B

. |( k* i4 L+ ?GCP was developed by the regulatory authorities of the EU, Japan and US in a steering group termed the Tripartite International Conference on Harmonisation (ICH) and provides international assurance that:% C$ ~+ |6 `( \" P6 Y1 D. p: k5 i6 d
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Data and reported results of clinical investigations are credible and accurate, and
. x3 Z3 |  F# H) j3 D6 ~Rights, safety and confidentiality of participants in clinical research are respected and protected  i; G5 d: F( q
It was finalised in 1996 and became effective in 1997.  When first expounded, it was an internationally recognised as best pratice, but was not enforcable by law.. \. l. ?& Z: \5 E

: S! V5 D9 k& i7 }1 k5 F9 DHowever, with the advent of the Medicines for Human Use (Clinical Trials) Regulations 2004 and the recent EU Directive on Good Clinical Practice, compliance with GCP is now a legal obligation in the UK/Europe for all trials of investigational medicinal products .5 m) Q6 r9 ]2 S' q

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3 ?9 \, ?- |" B5 ~GCP - 13 Principles- I; a  J2 G' A) W# i
ICH GCP指导原则包括13项基本原则。所有的原则均基于赫尔辛基宣言。
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  k! N! Q: T+ h1.Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
/ ^' R$ `, w+ x: f5 ^5 q第一项原则是,实施临床试验需符合源于赫尔辛基宣言中的伦理原则,同时与临床试验质量管理规范和当地的法规相符合。, L2 R$ O6 n' f/ O* J( T' W) v
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2.Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
# j8 W) Z( p3 S9 m1 n第二项原则是,在进行临床试验以前,需权衡可预见的危险和不便与给受试者和社会可能带来的益处。只有在可预期的益处超过危险时才可开始和继续临床试验。! d+ F. B% g, C4 q8 U- I
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  Q; p3 ~, p- L: k: S3.The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. , {# D  Q( c6 O) w
第三项原则:受试者的权利、安全和健康将是最主要的考虑因素,它们应置于社会的和科学的利益之上。# |* }( c0 r* I# ?9 u
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4.The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.2 O( M( I2 B: a) H0 K( d
第四项原则:已有的试验用药品的临床前与临床资料须足以支持拟进行的临床试验。7 H7 h- w! `# x$ H/ @

4 i, F+ D- ^6 I7 m0 `9 i0 D% b7 w5.Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
0 f7 I* P, I3 @& e- b第五项原则:临床试验须具备科学性并在试验方案中有详细明确的描述。对试验方案的要求在ICH GCP指导原则中也有陈述。/ Y" d/ G2 ^; Q: T+ t* O

* W9 n3 W* p4 t# V6.A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.
) r4 S0 W; e! l$ t% n第六项原则:临床试验的实施需遵照试验方案进行,试验方案须已获得了机构审查委员会或独立伦理委员会的批准或支持意见。这意味着在获得伦理委员会批准之前,临床试验不能启动。+ W% Q6 J. y9 ?

0 ?( M3 e& h4 n. Q7.The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.3 P. [! y4 V0 [7 L
第七项原则:为受试对象提供医疗服务及为其作出医疗决策总是有资格的医师或牙医的责任。这意味着,无论谁是主要研究者,为受试对象提供医疗服务的必须是有资格的医师。
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' e/ G) j6 `3 Q9 s8 e3 P4 g- [6 e8.Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).3 g" v! u2 z# C
第八项原则:每个参与临床试验的人员应具备一定资格,如接受过相关的教育、培训和有以往工作的经历。通常,确定所有参与临床试验的人员确已通过教育、培训和经验获得了资格是申办者的责任,而这常需要在试验前通过实地访问、会见和面试研究人员来落实,也可通过查看研究人员的简历(CV)来确定。$ u: E* H, M9 f0 V0 A& N$ T. n( N

: [# Y$ K; i# ?% [4 w& c9.Freely given informed consent should be obtained from every subject prior to clinical trial participation.8 Y& ~1 @( v; R2 I7 K4 f: T
第九项原则:在参加临床试验前应获得每个受试者的出于自愿的知情同意。这一点非常重要,在临床试验开始前一定要获得受试者的自愿给予的知情同意,否则不能筛选或入选。4 R8 V1 f9 A5 y$ N8 k

: A2 H2 {5 D% N) O) C9 x, s/ [$ G) I10.All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.4 M/ |1 A* v7 z
第十项原则:所有的临床试验信息应以某种方式记录、处置和保存,以便可以准确的报告、解释和核实。
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$ I5 [" R' x1 c9 n- T11.The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).% u7 W* k5 m% H+ V! q
第十一项原则:可以辨别受试者身份的记录应妥善保密。) _8 _9 I& o% W+ l6 x& o
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12.Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol. * G7 s0 i/ G8 R; N1 _5 h* U) h
第十二项原则:临床试验用药品的制备、处置和保存应与适用的药品生产质量管理规范(GMP)相符合。GMP较GCP更早存在,且世界上很多国家为试验用药品的制备和处置制订了相应的GMP标准。在临床试验中药品的使用应与被批准的试验方案一致。在试验方案中,有专门针对试验用药品的处置和保存提供详细指导的章节。
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- p7 s: N* e( V4 C3 x1 ]& b7 D13.Systems with procedures that assure the quality of every aspect of the trial should be implemented.
/ S7 T. i) Y, L- m8 G- q. i第十三项原则:确保临床试验各方面质量的系统和程序应得到贯彻,而这通常是申办者的责任。

013595en.pdf

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ICH GDP Guideline

ich_fda_03-01-01.pdf

57 KB, 下载次数: 12, 下载积分: 金钱 -1 钢镚

ICH Guidelines for GCP

rongxuan 发表于 2009-3-17 00:04:02 | 显示全部楼层
:handshake
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WWY2009 发表于 2011-11-16 10:15:41 | 显示全部楼层
it is perfect~~~~~~~~thanks~~
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匿名  发表于 2018-1-15 19:45:01
无法下载哎~求打包602157239@腾讯QQ邮箱
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