# Part 1: Introduction to Good Clinical Practice (GCP)

# What is Good Clinical Practice?

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.

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.

# Why is GCP training necessary?

This training is important for all staff involved in Clinical Research and ensures an understanding of the principles adopted in research.

• 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.

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.

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.

# Part 2: Good Clinical Practice Guidelines

# What are the Good Clinical Practice guidelines?

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.

整合了早期医学伦理守则中的许多相同原则，GCP 指南为涉及人类参与者的研究提供了一个公平、科学合理的框架。ICH GCP（R1）指南于 1996 年 6 月 10 日发布，并于 1997 年在美国联邦公报上公布，于 2016 年 11 月 9 日修订为 R2 版本。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.
  确保临床试验参与者的权利、安全和保密性得到保护。
• To ensure that the data collected in clinical trials, as well as the reported results of clinical trials, are accurate and credible.
  确保在临床试验中收集的数据以及报告的临床试验结果准确且可信。

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，例如那些涉及试验产品、上市药物、医疗设备或行为干预的研究。

# ICH GCP Principles

1. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
   临床试验应根据源自《赫尔辛基宣言》的伦理原则进行，并符合 GCP 和适用的监管要求。
2. Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial participant and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
   在试验开始之前，应权衡可预见的风险和不便与个别试验参与者及社会的预期利益。只有当预期利益足以证明风险合理时，才应启动并继续进行试验。
3. The rights, safety, and well-being of trial participants are the most important considerations and should prevail over the interests of science and society.
   试验参与者的权利、安全和福祉是最重要的考虑因素，应优先于科学和社会利益。
4. The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
   关于研究产品的现有非临床和临床信息应足以支持拟议的临床试验。
5. Clinical trials should be scientifically sound and described in a clear, detailed protocol.
   临床试验应具有科学性，并在清晰、详细的方案中描述。
6. A trial should be conducted in compliance with a protocol that has received prior institutional review board (IRB) approval.
   试验应按照已获得机构审查委员会（IRB）批准的方案进行。
7. The medical care given to, and medical decisions made on behalf of, participants should always be the responsibility of a qualified physician or, when appropriate, a qualified dentist.
   对参与者提供的医疗护理和代表他们做出的医疗决策应始终由合格的医生或在适当情况下由合格的牙医负责。
8. Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
   每个参与试验的个人都应通过教育、培训和经验来胜任其各自的任务。
9. Freely given informed consent should be obtained from every participant prior to clinical trial participation.
   在参与临床试验之前，应获得每位参与者的自由知情同意。
10. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification.
    所有临床试验信息都应以允许准确报告、解释和验证的方式记录、处理和存储。
11. The confidentiality of records that could identify participants should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
    应根据适用的监管要求，尊重隐私和保密规则，保护可能识别参与者的记录的机密性。
12. Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
    研究产品应按照适用的良好生产规范（GMP）进行制造、处理和储存。它们应根据批准的方案使用。
13. Systems with procedures that assure the quality of every aspect of the trial should be implemented.
    应实施确保试验各个方面质量的系统和程序。

Click Here to read and download the ICH Guideline E6 Good Clinical Practice documentation.

# What is the Code of Federal Regulations?

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（CFR）是美国政府行政部门和机构在《联邦公报》上发布的规则的编纂（系统安排）。良好临床规范（GCP）的原则被编入 CFR 的几个部分或标题中。不遵守这些规定可能导致研究项目暂停以及罚款和处罚。

# Which parts of the CFR must researchers be familiar with?

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：

# Part 3: Other Federal Regulations

# What other federal regulations must researchers be familiar with?

Research that involves the use of controlled substances must comply with U.S. Drug Enforcement Administration regulations (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:

• 21 CFR 210 — Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; and
• 21 CFR 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals.

Another Federal law is the Health Insurance Portability and Accountability Act (HIPAA) Privacy Ruleand 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).

NIH policies regulate grant management. For more information on the NIH Grants Policy, reference the website here.

# What additional regulations affect clinical research?

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.

# Part 4: Summary of Key Points

• 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:

  • The rights, safety, well-being, and confidentiality of trial participants are protected.
  • The data collected in clinical trials as well as the reported results of clinical trials are credible and accurate.

• 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.

• 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.

• 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.

• 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.

• 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.