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1、GCP指南中英文对照GCP基础指南中英文双语对照来源:发布时间：2010714我要评论(3）分享到：0Tags： GCPIntroduction前言(赵宁翻译 meking第一次校对cassals第2次校对)The overall aim of this work is to provide a reference book which describes the general framework for conducting GCP-compliant clinical research， particularly pharmaceutical industry clinical rese
2、arch。 Hopefully, it is written in simple enough language so that it is readable to those who are new to the business: however, we have also included many examples from our years of practice to sustain the interest of a more experienced group。 Pharmaceutical industry personnel （e。g。 monitors， data ma
3、nagement personnel， statisticians, medical advisers, and study medication or device suppliers from both sponsors and CROs） will find many helpful hints and examples of how the situation can go awry。 We also hope the book will be of value to new and experienced personnel at clinical study sites inclu
4、ding investigators, research nurses, study site coordinators, clinical laboratory staff and pharmacists. Members of ethics committees and IRBs should find this reference book useful to increase their understanding of how clinical research operates from the perspective of the pharmaceutical industry，
5、 and auditors and inspectors will especially find the book helpful because of the numerous references to audit findings. There might be interest from an academic perspective as well。编写这本书的目的是为执行依从GCP的临床试验提供一本描述总体框架的参考书，特别是针对制药企业的临床试验。本书尽量以通俗的语言编写，以期那些刚刚进入临床研究领域的新手们也能读懂。然而，我们在这本书中也引用了许多实例都是我们多年来有经验的组
6、织在执行上所关注的议题.制药企业的工作人员（如监查员、数据管理人员、统计学家、医学顾问以及给申办者和CRO公司供应药物或设备的供应商等)会发现许多关于如何歪曲临床研究结果的有益提示和实例。我们也希望这本书对新的和经验丰富的临床基地的工作人员（包括研究者、研究护士、基地协调员、临床实验室人员和药剂师)来说也很有参考价值。伦理委员会/机构审查委员会的成员会发现，这也是一本有用的参考书籍，可以加强他们了解制药企业是如何操作临床试验的。尤其是稽查者和视察者会发现这本书很有帮助，因为本书引用的大量资料皆是来自于稽查者在执行稽查时的发现。从学术角度来看，本书也是很有意义的。First of all， we
7、 should make it clear that in our opinion there is no such thing as a fully GCPcompliant clinical study. It is almost impossible to achieve the ideal proclaimed in the existing guidelines and regulations。 However， this does not mean we should not strive for the best standard possible。 You must think
8、 beyond the minimum standard if you really want to do a good job and ensure the best quality possible. Slavish adherence to guidelines and regulations will not work: you must be convinced of the basic logic， ethics and science behind GCP requirements. Going for the most expedient and cheapest route
9、will not only result in a poorer standard but it may also cost lives.首先,我们应该清楚，在我们看来，没有完全依从GCP的临床研究，完美遵从目前指导原则和法规几乎是不可能的。但是,这并不意味着我们就不应该尽可能达到最好的标准。如果你确实想要做好工作并尽可能确保高质量，就必须考虑超过最低标准。机械的遵从指导原则和法规是没有用的，但必须遵循GCP要求的基本的逻辑、伦理和科学原则。一味的寻求最方便、最便宜的途径将不仅仅导致一个更低的标准，也可能增加成本. How much noncompliance should we tolera
10、te？ In 1996, we published a book on GCP compliance based on the findings of our audit experience at 226 investigator study sites, involving studies conducted in 20 different countries， and audited by an independent external audit team between 1991 and 1995。 GCP compliance was compared for various fa
11、ctors and the data patterns suggested some interesting trends. First, the overall level of GCP compliance was generally poor across all investigator study sites and far below the expectations of guidelines and regulations。 (In many areas， the studies were possibly dangerous for study subjects, in ou
12、r opinion.) Second， there were no important differences in studies with regard to the year in which the study was conducted. Basically, all the new regulatory efforts, particularly in Europe, did not show a positive effect on standards.(However, a survey over a five to sixyear time period is possibl
13、y too limited to draw conclusions on this point.） Third, there were no important differences in studies which used a CRO (contract research organization) compared to those which did not。 This appears to be because CROs simply follow the standards of the sponsor responsible for the conduct of the stu
14、dy rather than setting consistent and better standards themselves。 Fourth， some slight differences between phases of studies were observed， with better compliance in early phase studies. However, this should not be surprising since a Phase I single-centre study with 20 subjects is much easier to con
15、trol than a Phase III multicentre multinational study involving several hundred study subjects. Fifth， there were some slight differences between therapeutic areas, but this was probably linked to the standards of the sponsor or CRO managing the studies。 Sixth, overall， there were no basic overall d
16、ifferences between levels of GCP compliance in different countries. (However， a later analysis of selected items showed some individual differences between countries： for example, direct access to source documents was achieved 100 of the time at US sites， but not as frequently in other countries.)Th
17、e only apparent important differences in levels of GCP compliance were between the different sponsors (mostly pharmaceutical companies) managing the studies. The main conclusions reached from analysis of this audit database were that overall standards of GCP compliance greatly needed improvement， an
18、d that standards were only as good as the sponsor managing the study regardless of where in the world the study was being conducted. In theory, good research could be conducted anywhere provided it was managed properly.我们可容许多大的非依从性呢？ 1996年我们出版了一本关于GCP依从性的书,此书根据我们在226个研究基地的稽查发现编写,涉及了1991年到1995年间20个不同
19、国家并由独立的外部稽查小组稽查的研究。比较各种因素下的GCP依从性,结果显示出一些有趣的趋势.首先，所有基地的GCP依从性的总体水平普遍较差，并且远低于指导原则和法规的预期。（在我们看来，在很多地区，研究对受试者来说可能是危险的。）第二，关于上述年份进行的研究没有很大差别。基本上所有新调整的尝试，都没有表现出对标准的积极影响，特别是在欧洲。（然而，通过五、六年的调查研究得出这点结论可能会比较局限。）第三，使用CRO（合同研究组织）的研究和不用CRO的研究比较，没有很大区别。这可能是由于CRO只是简单的遵照负责临床研究的申办者的标准规程而不是自己制定相应的、更好的标准规程。第四，各期研究间可以观
20、察到一些细微的差别，早期研究的依从性更好.然而这并不令人感到奇怪，因为仅有20位受试者的单中心I期研究比一个涉及几百位受试者的国际多中心的III期研究更容易控制。第五，在治疗领域之间存在一些细微的差别，但这可能与申办者或CRO管理研究的标准规程有关。第六,总体来说，不同国家的GCP依从性水平没有根本性的差别。（但是，对所选项目的随后分析表明国家间有一些个别的差异：比如，在美国的基地稽查时，每次必须直接查阅原始文件，但在其它国家没有那么频繁）。GCP依从性的水平唯一明显的差别是在组织研究的不同申办者中（大部分为制药公司）。从这个稽查数据库的分析中得出的主要的结论是GCP依从的整体标准规程还需很大
21、的改进，不管在世界哪个地方开展研究，标准规程是申办者管理好研究最好的工具。）理论上,如果进行恰当地管理，任何地方都可以开展好的研究. There is a desperate need to fill the educational gaps in our understanding of GCP。 Frankly, we are often appalled at how little those who are doing the job understand their responsibilities。CONDUCTING GCP-COMPLIANT CLINICAL RESEARCH
22、 IS A SERIOUS UNDERTAKING. The welfare of current study subjects and future patients is at stake and we must never underestimate that the application of GCP requires continuous vigilance and care. We must get our priorities straight first. Investigators complain that all this GCP is ruining real sci
23、ence. The pharmaceutical industry complains that GCP requirements make drug development more expensive and more time-consuming。 Ethics committees and IRBs complain （rightly） that they do not simply exist to take care of the pharmaceutical industry and anyway, who is educating them with regard to the
24、 new regulations and guidelines? Perhaps the smallest voice of objection has come from the hundreds of thousands of study participants， those for whom we should be most concerned about achieving the right standards. However, the latter situation is changing and the protests of consumer groups， patie
25、nt advocates, and those who must pay for our healthcare, are probably most responsible for the emergence of the many new guidelines and regulations in the last 1520 years。 （In the United States， these changes occurred much earlier.) The study subject obviously has the most to lose from non-complianc
26、e with GCP and we have tried hard to look at GCP from the point of view of what is best for the study subject throughout this book。急需填补GCP教育的空白。坦白地讲，我们非常震惊工作人员对他们的工作职责理解如此之少。进行依从GCP的临床研究是一项严肃认真的事业。当前研究的受试者和未来病人们的安康正处于危险中，因此我们决不能轻视GCP要求的持续的警觉和小心。我们首先必须正直。研究者们抱怨“都是GCP毁了真正的科学”。制药企业抱怨GCP的需求使得药物研发更昂贵，更耗时
27、。伦理委员会委员和机构审查委员会正当地抱怨他们不只是因为制药企业而存在，但谁来对他们进行新规则和指导方针的培训？也许最小的反对声音来自于成百上千的受试者，对于这些受试者,我们最应该关心获得权益的程序。但是,近来的形势正在改变，消费者的抗议，病人的拥护者和那些必须为我们的医疗保健付费的人可能最应当对过去15到20年里出现的许多新的指导方针和规则负责。(在美国,这些改变出现更早。)研究的受试者明显地大量从GCP非依从性研究中脱落，这本书中，我们努力从对受试者什么是最好的这个观点出发来看GCP。Many complain that GCP is a boring topic。 We try to o
28、vercome this in training courses by providing as many practical examples as possible。 In this book， we have also taken the same approach。 At the end of each chapter， there is a case study describing all the serious findings of GCP noncompliance at a particular study site. Further， throughout the boo
29、k， there are anecdotes describing incidents which might help the reader understand certain points. All of these reports are based on true events, but the reader will understand that we have had to anonymize these as much as possible and must forgive us for a few generalizations. Lists of requirement
30、s， which might be tedious if they are not relevant to a particular situation， have been presented in checklists so that they can be skipped in the first reading and referenced at a later point。 (These checklists are not exhaustive but they might provide a helpful starting point for preparing standar
31、d operating procedures。） We have also included our audit findings throughout the text to emphasize the levels of non-compliance with certain requirements。 As independent auditors， we are in a wonderful position to be able to present the negative findings as openly as possible. Obviously, it would be
32、 difficult for sponsor and CRO personnel, and site personnel， to publicly criticise their operations。 We hope readers will resist the temptation to dismiss negative findings.Criticism is not intended to be antiindustry or antiresearch it is intended to be pro-patients. After all， this is what GCP is
33、 all about.许多人抱怨GCP是一个另人厌烦的话题。我们试图在培训课程中通过提供尽可能多的实际案例来克服这一点。在这本书中,我们也采取了同样的方法。在每一章的最后，都有一个案例分析，描述在一个特定的研究基地中不依从GCP的所有重要发现。而且，这本书中有许多简要描述的偶然事件，这可帮助读者理解其中的某些要点。所有的报告都基于真实的事件，但是读者应理解我们不得不尽可能隐去他们的名字，也应当原谅我们稍微的泛化。需要进行的活动列表若与一个特定的情境不相关会使人感到厌烦,我们将在后续的清单中列出，因此第一次阅读时可跳过，在随后的阅读中可以作为参考。（这些清单可能不详尽，但是可以为准备标准操作规程提供一个有益的起始点。）在文中我们也引用了我们稽查的发现来强调特定需求非依从的程度。作为独立的稽查者，我们处在一个很好的职位,可以尽可能公开地发表阴性结果。显然,对申办者、CRO和基地的工作人员来说是难以公然地批评他们的操作的。我们希望读者能抵制消除阴性结果的诱惑。批评并不是为了反对企业或反对研究，只是为了保护病人。毕竟这是GCP的真正目的。