现行的临床研究实施（GCP）规范 (中英对照)

                  The Current Rules for Conducting Clinical Research 

现行的临床研究实施规范 

    Clinical research must be conducted according to a set of standards which has been formalized in many international guidelines and regulations. The ultimate aim is to protect all research participants and assure that only worthwhile treatments are approved for use for future patients. GCP principles，although quite straightforward, are not easy to implement (section 1.1).

   临床研究必须按照一系列的标准进行，这些标准已经在许多国际指南和法规中被正式化，其最终目的是为了保护所有临床参与者，确保只有有价值的治疗方法被批准用于将来的病人身上，尽管GCP的原则非常机械，但实施起来并不简单。(1.1节) . 

   One could ask why we need a set of rules if the requirements are so obvious - after all, reasonably intelligent people at all levels are managing the research activity and surely all physicians consider protection of patients as their primary objective. Unfortunately, experience has shown that the requirements are much more complex than they appear and there are serious conflicts of interest. Pharmaceuticals companies obviously develop products which will make profits, investigators are paid to conduct clinical research, patients in some types of studies may be paid to participate and even ethics committees operate to make a profit (e.g. some IRBs in the USA). Thus the public has demanded some control and regulations have arisen. A brief summary of existing regulations is presented in this chapter, but we hope otherwise, throughout this book, to appeal to a sense of logic, science and ethics which we can all understand (section 1.2).

有人可能会问，如果要求是如此简单，那为什么我们还需要一套法规，毕竟，在所有水平都是相当资历的人在管理研究活动，所有的内科医生都把保护病人作为他们的基本目标，不幸的是，经验证明要求比他们想象的要复杂的多，且存在严重的利益冲突，很明显，医药公司开发新药是为了获得利润，研究者执行临床研究可得到报酬，有些研究中的病人参加可得到报酬，甚至伦理委员会运作也可获益（例如美国的一些IRB）。因此，公众就要求一些控制措施，法规在这种时候出台了，在本章仅简要介绍现行法规，但是我们还是希望，通过这本书来呼吁我们都能理解的临床研究中逻辑、科学和伦理原则的意识。(1.2节)。 

    To make sure the standards for clinical research are set before studies begin and to check on those standards, many systems and process must be established. These are formally undertaken by pharmaceutical companies and CROs in the form of project planning, SOPs, training, monitoring, data processing, etc. (section 1.3).

   为了保证研究开始之前建立临床研究的标准以及核查这些标准，许多系统和程序必须建立。这些常由医药公司和CRO公司承担，如项目计划、SOP、培训、监查、数据处理等。（1.3节）

    Where there are regulations, there are usually systems to check on conformity with those regulations. The procedures of auditing and inspection are the most valid means of checking on compliance as they are required, by definition, to be conducted independently of the clinical study process. Auditors and inspectors are supposed to be unbiased in their review. Auditing is usually undertaken by the conducting the research to check on compliance with their own standards and basically to preempt the inspectors. Inspectors are there in the interests of the public: they are supposed to be independent of the researchers and other participants, such as ethics committees (section 1.4 and 1.5).

    哪里有规则，通常就有系统去核查与规则的一致性，稽查和视察程序是核查是否按照他们的要求进行的最有效的方式，从定义来看，为了临床研究过程独立执行，稽查员和视察员审查时应该是没有偏见的，通常在临床研究过程中进行稽查以核查是否与他们的标准一致的，基本上稽查早于视察。视察者代表公众利益，他们应该独立于研究者和其他参与者，比如伦理委员会（1.4和1.5节） 

   The ultimate in GCP non-compliance is fraud. Although this is a negative topic, and most of us would like to feel it does not happen, unfortunately there have been some serious cases which have been uncovered and brought to the attention of the public. There are probably many other situations which have never been pursued, but everyone needs to be sensitive to this issue and prevent its occurrence (sections 1.6).

   不遵守GCP最不能接受的是欺骗，尽管是一个负面主题，我们中大部分人还是愿意认为它没有发生。不幸的是，有一些严重的例子已经被揭发，引起了公众的注意。可能还有一些情况没有被发现，但是每个人都需要对此类事件关注，并防止其发生。