GCP的复习资料

GCP的基本原则(中英文对照)

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1.1 THE BASIC TENETS OF GCP

GCP的基本原则

The primary reason for the presence of a GCP code of practice is to protect human rights.

If this simple principle could be remembered at all times throughout the research process,

many of the so-called vagaries of GCP could be resolved. Unfortunately, it is not so easy

to keep this principle foremost when one is trying to get a job done or if there is a conflict

of interest. Collecting honest and accurate data is a major part of GCP to ensure that data

have integrity and valid conclusions may be drawn from those data. Data should be

reproducible: that is, if the study were to be conducted in a similar population using the

same procedures, the results should be the same. After all, the results of clinical research

will be imposed on new patients in the future. To help assure us all of the integrity and

reproducibility of research results, the whole process should be transparent and that

means that everything must be documented so that an external reviewer can verify that

the research was actually conducted as the researchers reported that it was conducted.

Many systems and processes must be in place to implement GCP and the documentation

must clearly indicate compliance with those systems (Checklist 1.1-1).

GCP出现的最基本的原因是为了保护人权，如果这些简单的原则能够在整个研究过程中被记住，许多所谓的对GCP的偏离行为都能够解决，遗憾的是，当一个人努力去完成一项工作或存在利益冲突时，保持这个基本原则并非易事。收集真实的，准确的数据是GCP主要工作之一，以确保从这些数据中得出完整和有效的结论。这些数据应该是可重现的，就是说，如果用相同的程序应用到相似的人上，结论应该是一致的。毕竟，这样的临床研究结论将来要应用到新的病人身上。为了确保临床研究结果的完整性和重现性，整个过程应该是透明的，也就是说，每个操作必须被记录，以便外部审查者能够确认研究确实是按临床研究报告那样进行的。执行GCP需要制订许多系统和过程，记录的文件必须清楚表明其与这些系统的一致性（见表1.1-1）。 Checklist 1.1-1. General Systems and Procedures for Implementation of

GCP

表1.1-1 GCP实施的一般系统和过程

The following systems and procedures must be established by clinical

researchers to ensure compliance with GCP requirements:

为了确保研究与GCP要求的一致性，临床研究者必须建立下面的系统和程序。

l Planning: studies must be conducted for valid (ethical and scientific)

reasons;

计划：研究必须按照适当的目的进行（伦理的和科学的）

l Standard operating procedures: research procedures must be declared in writing so

that reviewers can determine the standards which are being applied and so that users

have a reference point;

标准操作程序：操作规程必须书面发布，以便审查者有一个判断的标准以及使用者有一个操作参考。

l Qualified personnel: all personnel (sponsor/CRO and study site) must be

experienced and qualified to undertake assigned tasks. Documentation of qualifications

and training must be evident.

研究人员资格：所有的人（申请人/CRO和研究基地）必须是有经验和资格承担分配的任务，必须有相应的资历和培训文件。

l Ethics committee review and approval: all studies must be independently reviewed

by ethics committees/IRBs, to assess the risk for study subjects, before clinical studies

begin. Review must continue throughout the study.

伦理委员会审批：临床研究开始之前，为了评估研究对受试者的风险，所有研究必须经伦理委员会或IRB独立审查，审查必须贯穿整个研究过程。 l Informed consent: all study subjects must be given the opportunity to personally

assess the risk of study participation by being provided with certain information. Their

assent to participate must be documented.

知情同意：必须告知所有受试者足够的信息，让其有机会自己评价参加研究的风险，并且记录他们的同意。

l Well-designed study: all studies must have a valid study design documented in a

protocol so that it can be fully reviewed by all interested parties. The data collection

plans, as described in the CRF, are part of the protocol.

精心设计的研究：为了所有感兴趣人员能够充分审查方案，所有的研究方案中必须说明有效的研究设计方法.设计作为方案的一部分，像CRF表格中描述的数据采集计划，也应作为方案的一部分。

l Monitoring: a primary means of quality control of clinical studies involves frequent

and thorough monitoring by sponsor/CRO personnel;

监查：临床研究质量控制的主要方法包括申办者/CRO人员频繁的和全程监查。

l Control of study medications/devices: the product being studied must be managed

so that study subjects ultimately receive a safe product and full accountability can be

documented;

研究用药物/器械的管理：研究用品必须被管理，以便受试者最终使用的是安全的产品，研究用品使用必须记录。

l Integrity of data: data must be honest. Data must be reviewed by site personnel,

monitors and data processing personnel.

数据的完整性：数据必须真实，必须经试验人员，监查员，和数据处理人员审查。

l Quality assurance: systems for assuring quality and for checking quality must be

established and followed at all stages;

质量保证：质量保证和检查系统必须建立，在整个试验过程中必须遵守。 l Archives: documentation of research activities must be securely retained to

provide evidence of activities.

存档：研究活动的文件必须被安全保存，作为活动的证据。

1.2 THE GENERAL REGULATORY FRAMEWORK FOR GCP

1.2 GCP的基本规章制度

(This section is only intended to provide a fairly general review of the regulatory

framework and the interested reader is advised to seek expert advice elsewhere.)