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：2010-7-14 我要评论(3)

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Tags: GCP

Introduction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 research. 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 management 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 including 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, 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 should make it clear that in our opinion there is no such thing as a fully

GCP-compliant 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 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 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 non-compliance should we tolerate? 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 factors 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 our 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 six-year time period is possibly 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 study 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 control 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 differences between levels of GCP