第1个回答 2022-06-16
Part 1: Introduction to Good Clinical Practice (GCP)
Part 2: Good Clinical Practice Guidelines
Part 3: Other Federal Regulations
Part 4: Summary of Key Points
Good Clinical Practice (GCP) is an international ethical and scientific standard for conducting biomedical and behavioral research involving human participants. The objective of this guideline is to provide a unified standard across the European Union (EU), Japan, the United States, Canada, and Switzerland to facilitate the mutual acceptance of data from clinical trials by Regulatory Authorities.
良好的临床实践（GCP）是一种涉及人类参与者的生物医学和行为研究的 国际道德和科学标准。 本指南的目的是提供欧盟（欧盟），日本，美国，加拿大和瑞士的统一标准，以促进监管机构的临床试验中的数据相互接受。
The current system of Good Clinical Practice has evolved, in part, in response to revelations of past episodes in which research participants were grossly abused. Exposure of these incidents provided much of the momentum for the development of regulations and ethical guidelines on the protection of human research participants.
目前良好的临床实践体系的发展，部分是为了应对过去研究参与者被严重虐待的事件。这些事件的曝光为制定保护人类研究参与者的法规和道德准则提供了很大动力。
This training is important for all staff involved in Clinical Research and ensures an understanding of the principles adopted in research.
这项培训对参与临床研究的所有工作人员非常重要，并确保了解研究中通过的原则。
· GCP is widely accepted and expected in all research involving human participants.
· GCP is not specific to a protocol, but rather is general and applicable to all protocols.
· GCP在所有涉及人类参与者的研究中被广泛接受和期望。
· GCP并非特定于某一协议，而是通用的，适用于所有协议。
Anyone directly involved in the design or conduct, oversight, or management of research involving human participants, including research site staff, back-up staff, contractors, subcontractors, and consultants who perform key study functions, should complete the GCP training. Non-study staff at the research site who provide standard care or other non-study related services should be encouraged to complete the GCP training, but they are not required to do so.
任何直接参与设计或进行、监督或管理涉及人类参与者的 研究的人员 ，包括 研究现场工作人员 、 后备人员 、 承包商 、 分包商 和 履行关键研究职能的顾问 ，应完成GCP培训。应鼓励研究现场提供标准护理或其他非研究相关服务的 非研究人员 完成GCP培训，但不要求他们完成。
The course is self-paced and takes approximately 4-6 hours to complete. Completion of the course is required every three years for NIH-affiliated staff to ensure that all researchers stay informed of developments regarding GCP, such as changes in federal regulations concerning the protection of vulnerable research participants , electronic data, or privacy protections . Others are encouraged to consult and comply with their institutional, regulatory, and other oversight committee guidelines for recertification requirements.
课程自行安排，大约需要4-6小时完成。NIH附属人员每三年必须完成一次课程，以确保所有研究人员随时了解GCP的发展情况，如联邦法规中关于 保护弱势研究参与者 、 电子数据或隐私保护 的变化。我们鼓励其他人咨询和遵守其制度，监管和其他监督委员会的 重新认证 要求。
The Good Clinical Practice (GCP) guidelines were prepared in association with the International Council for Harmonization (ICH). Consolidating many of the same principles set out in earlier codes of medical ethics, the GCP guidelines provide a framework for the fair, scientifically sound conduct of research studies involving human participants. The ICH GCP (R1) guidelines, dated June 10, 1996, were published in the U.S. Federal Register in 1997 and revised to version R2 on November 9, 2016. These guidelines apply to all research involving human research participants.
良好临床实践（GCP）指南是与国际协调理事会（ICH）联合制定的。GCP指南综合了早期医疗道德规范中规定的许多相同原则，为公平、科学合理地开展涉及人类参与者的研究提供了框架。1996年6月10日发布的ICH GCP（R1）指南于1997年在《美国联邦公报》上公布，并于2016年11月9日修订为R2版。这些指南适用于所有涉及人类研究参与者的研究。
The purpose of the ICH GCP guidelines is twofold:
· To ensure that the rights, safety, and confidentiality of participants in clinical trials are protected.
· To ensure that the data collected in clinical trials, as well as the reported results of clinical trials, are accurate and credible.
ICH GCP指南的目的有两个：
· 确保临床试验参与者的权利、安全和保密受到保护。
· 确保临床试验中收集的数据以及报告的临床试验结果准确可信。
The principles in this guideline may be applied to all clinical investigations involving human participants, such as those involving an investigational product, a marketed drug, a medical device, or a behavioral intervention.
本指南中的原则可适用于所有涉及人类参与者的临床研究，如涉及研究产品、上市药物、医疗器械或行为干预的临床研究。
The Code of Federal Regulations (CFR) is the codification (systematic arrangement) of rules published in the Federal Register by the executive departments and agencies of the U.S. Government. The principles of Good Clinical Practice (GCP) are codified in several sections, or titles, of the CFR. Noncompliance with these regulations may result in suspension of a research study as well as fines and penalties.
《联邦法规法典》（CFR）是美国政府行政部门和机构在《联邦公报》中公布的规则的编纂（系统安排）。良好临床实践原则（GCP）编入CFR的几个章节或标题中。不遵守这些规定可能导致研究暂停以及罚款和处罚。
Researchers and clinicians participating in clinical trials need to be familiar, at a minimum, with the following sections of the CFR, which are directly relevant to research involving human participants:
参与临床试验的研究人员和临床医生至少需要熟悉CFR的以下章节，这些章节与涉及人类参与者的研究直接相关：
[21 CFR 11] This section regulates the handling of electronic data and electronic signatures when an Electronic Data Capture system is used. It is enforced by the U.S. Food and Drug Administration (FDA). For more information on 21 CFR 11, click here .
【21 CFR 11】本节规定了使用 电子数据采集系统时电子数据和电子签名的处理 。它由美国食品和药物管理局（FDA）强制执行。有关21 CFR 11的更多信息，请单击 此处 。
[21 CFR 50] This section, enforced by the FDA, regulates the informed consent process, setting out the elements of informed consent, exceptions from the general requirements, and other related information. (See related material from the Informed Consent module.) For more information on 21 CFR 50, click here .
【21 CFR 50】本节由FDA强制执行，规定了 知情同意 程序，规定了知情同意的要素、一般要求的例外情况以及其他相关信息。（参见知情同意模块中的相关材料）有关21 CFR 50的更多信息，请单击 此处 。
[21 CFR 54] This section, enforced by the FDA, regulates investigator conflicts of interest. For more information on 21 CFR 54, click here .
【21 CFR 54】本节由FDA强制执行，规范 调查人员的利益冲突 。更多关于21 CFR 54的信息，请点击 这里 。
[21 CFR 56] This section, enforced by the FDA, regulates the membership, responsibilities, and operations of Institutional Review Boards (IRBs). (See related material from the Institutional Review Boards module.) For more information on 21 CFR 56, click here .
【21 CFR 56】本节由FDA强制执行，规定了 机构审查委员会（IRB）的成员、职责和运作 。（参见机构审查委员会模块中的相关材料）有关21 CFR 56的更多信息，请单击 此处 。
[21 CFR 312] This section, enforced by the FDA, regulates the conduct of studies involving the use of Investigational New Drugs. (See related material from the Investigational New Drugs module.)For more information on 21 CFR 312, click here .
【21 CFR 312】本节由FDA强制执行，规定了涉及使用 试验新药的研究行为 。（参见研究新药模块的相关资料）有关21 CFR 312的更多信息，请单击 此处 。
[21 CFR 314] This section, enforced by the FDA, regulates the application procedure for approval of new drugs. For more information on 21 CFR 314, click here .
【21 CFR 314】本节由FDA强制执行，规定了 新药批准的申请程序 。有关21 CFR 314的更多信息，请单击 此处 。
[42 CFR 2 and 42 CFR 2a] These are the confidentiality regulations, which fall under the jurisdiction of the Department of Health and Human Services (DHHS). Section 2 deals with the confidentiality of alcohol and drug abuse patient records. Section 2a deals with the protection of research participants' identity. (See related material from the Confidentiality and Privacy module.) For more information on 42 CFR 2 and 42 CFR 2a, click here .
【42 CFR 2和42 CFR 2a】这些是属于卫生和公共服务部（DHHS）管辖的 保密条例 。第2节涉及 酒精和药物滥用患者记录的保密性 。第2a节涉及 研究参与者身份的保护 。（请参阅保密和隐私模块中的相关资料）有关42 CFR 2和42 CFR 2a的更多信息，请单击 此处 。
[45 CFR 46] This regulation also governs Institutional Review Board (IRB) membership, functions, and operations. In addition, it includes the general requirements for informed consent and codifies additional protections for vulnerable participants. Subpart A of this regulation is also known as the Common Rule. which has recently undergone revision and will be effective in 2018. Subparts B, C, and D include provisions for pregnant women, children, and prisoners in research studies. It is enforced by the DHHS Office for Human Research Protections . For more information on 45 CFR 46, click here .
【45 CFR 46】本法规也适用于 机构审查委员会（IRB）的成员、职能和运作 。此外，它还包括 知情同意的一般要求 ，并为 弱势参与者 制定了额外的保护措施。本法规的子部分A也称为 通用规则 。最近进行了修订，将于2018年生效。B、C和D子部分包括研究中针对 孕妇 、 儿童 和 囚犯 的规定。它由DHHS 人类研究保护办公室 执行。有关45 CFR 46的更多信息，请单击 此处 。
[45 CFR 160 and 45 CFR 164] These are the Health Insurance Portability and Accountability Act (HIPAA) privacy rules, which are enforced by the DHHS Office of Civil Rights .
【45 CFR 160和45 CFR 164】这些是 健康保险携带和责任法案 （HIPAA） 隐私规则， 由DHHS 民权办公室 执行。
Research that involves the use of controlled substances must comply with U.S. Drug Enforcement Administration regulations ( 21 CFR 1300 ).
涉及使用 受管制物质 的研究必须符合美国药品管理局（DEA）条例（21 CFR 1300）。
In addition to the Office of the Commissioner, the Food and Drug Administration (FDA) oversees scientific activities in four areas. These areas include Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations. Scientific investigations involving drugs are subject to FDA regulations. In addition to regulating the use of investigational new drugs (21 CFR 312) and marketing of drug (21 CFR 314) mentioned in Part 3 of this module, FDA regulations apply to Good Manufacturing Practice (GMP), such as:
除局长办公室外（OC），食品和药物管理局（FDA）还监督四个领域的科学活动。这些领域包括 医疗产品 和 烟草 、 食品和兽医 、 全球监管和政策以及运营 。涉及药物的科学调查受FDA规定的约束。除了规范本单元第3部分中提到的试验新药（21 CFR 312）的使用和药物的营销（21 CFR 314），FDA法规还适用于良好生产规范（GMP），例如：
[ 21 CFR 210 ] Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs;
【21 CFR 210】制造、加工、包装或贮存药物的现行优良制造规范;
[ 21 CFR 211 ] Current Good Manufacturing Practice for Finished Pharmaceuticals.
【21 CFR 211】成品药品的现行良好生产规范。
Another Federal law is the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and HIPAA Security Rule, which protects the privacy of research participants and their personal health information. (HIPAA is discussed in more detail in the Confidentiality & Privacy module, Part 8).
另一项联邦法律是《健康保险可携带性和责任法案》（HIPAA） 隐私规则 和HIPAA 安全规则 ，保护研究参与者及其个人健康信息的隐私。（HIPAA在保密和隐私模块第8部分中有更详细的讨论）。
NIH policies regulate grant management. For more information on the NIH Grants Policy, reference the website here .
美国国家卫生研究院的政策规范了补助金的管理。更多关于国家卫生研究院补助金政策的信息，请参考网站。
Countries, states, cities, and institutions may implement additional policies for the protection of human participants. These policies may impose requirements more stringent than those set down in federal regulations. Where more stringent local policies on human participant protection have been enacted, researchers must ensure at all times that their studies are designed and conducted in a manner that complies with both local and federal requirements.
国家、州、城市和机构可以实施额外的政策来保护人类参与者。这些政策可能会提出比联邦法规更严格的要求。如果制定了更严格的当地人类参与者保护政策，研究人员必须始终确保其研究的设计和实施符合当地和联邦要求。
Ⅰ. Good Clinical Practice (GCP) is an international ethical and scientific standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. This standard provides assurance that:
i. The rights, safety, well-being, and confidentiality of trial participants are protected.
ii. The data collected in clinical trials as well as the reported results of clinical trials are credible and accurate.
1、良好临床实践（GCP）是临床试验设计、实施、绩效、监测、审计、记录、分析和报告的国际伦理和科学标准。本标准保证：
（1）试验参与者的权利、安全、福利和保密性受到保护。
（2）临床试验中收集的数据以及临床试验报告的结果是可信和准确的。
Ⅱ、The current system of Good Clinical Practice has evolved, in part, in response to revelations of past episodes in which research participants were grossly abused.
2、目前的良好临床实践体系的发展，在某种程度上是为了应对过去研究参与者受到严重虐待的事件。
Ⅲ、The Good Clinical Practice guidelines provide a framework for the fair, scientifically sound conduct of research studies involving human participants. Therefore, all trials should be conducted according to Good Clinical Practice (GCP) and all research staff should be trained and remain current in GCP.
3、《良好临床实践指南》为公平、科学合理地开展涉及人类参与者的研究提供了框架。因此，所有试验都应按照良好临床实践（GCP）进行，所有研究人员都应接受培训，并保持GCP的最新状态。
Ⅳ、All key personnel who submit applications to the National Institutes of Health for competing or noncompeting projects that involve human research participants must receive training in the protection of human research participants.
4、向国家卫生研究院提交涉及人类研究参与者的竞争性或非竞争性项目申请的所有关键人员，必须接受保护人类研究参与者的培训。
Ⅴ、The Code of Federal Regulations (CFR) is the codification (systematic arrangement) of rules published in the Federal Register by the executive departments and agencies of the U.S. Government. The principles of Good Clinical Practice are codified in several sections, or titles, of the CFR. Noncompliance with these regulations may result in suspension of a research study as well as fines and penalties.
5、《联邦法规法典》（CFR）是美国政府行政部门和机构在《联邦公报》中公布的规则的编纂（系统安排）。良好临床实践的原则在CFR的几个章节或标题中进行了编码。不遵守这些规定可能导致研究暂停以及罚款和处罚。
Ⅵ、Countries, states, cities, and institutions may implement additional policies for the protection of human participants. These policies may impose requirements more stringent than those set down in federal regulations. Where more stringent local policies on human participant protection have been enacted, researchers must ensure at all times that their studies are designed and conducted in a manner that complies with both local and federal requirements.
6、国家、州、城市和机构可以实施额外的政策来保护人类参与者。这些政策可能会提出比联邦法规更严格的要求。如果制定了更严格的当地人类参与者保护政策，研究人员必须始终确保其研究的设计和实施符合当地和联邦要求。