Contents

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?

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.

良好的臨床實(shí)踐（GCP）是一種涉及人類參與者的生物醫(yī)學(xué)和行為研究的國際道德和科學(xué)標(biāo)準(zhǔn)怯晕。本指南的目的是提供歐盟（歐盟）碎捺，日本，美國而姐，加拿大和瑞士的統(tǒng)一標(biāo)準(zhǔn)凯力，以促進(jìn)監(jiān)管機(jī)構(gòu)的臨床試驗(yàn)中的數(shù)據(jù)相互接受催蝗。

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.

目前良好的臨床實(shí)踐體系的發(fā)展，部分是為了應(yīng)對過去研究參與者被嚴(yán)重虐待的事件伍宦。這些事件的曝光為制定保護(hù)人類研究參與者的法規(guī)和道德準(zhǔn)則提供了很大動力。

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.

這項(xiàng)培訓(xùn)對參與臨床研究的所有工作人員非常重要乏梁，并確保了解研究中通過的原則次洼。

?· 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在所有涉及人類參與者的研究中被廣泛接受和期望。

?· GCP并非特定于某一協(xié)議遇骑，而是通用的卖毁，適用于所有協(xié)議。

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.

任何直接參與設(shè)計(jì)或進(jìn)行落萎、監(jiān)督或管理涉及人類參與者的研究的人員亥啦，包括研究現(xiàn)場工作人員、后備人員练链、承包商翔脱、分包商?和履行關(guān)鍵研究職能的顧問，應(yīng)完成GCP培訓(xùn)媒鼓。應(yīng)鼓勵研究現(xiàn)場提供標(biāo)準(zhǔn)護(hù)理或其他非研究相關(guān)服務(wù)的非研究人員?完成GCP培訓(xùn)届吁，但不要求他們完成。

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.

課程自行安排绿鸣，大約需要4-6小時(shí)完成疚沐。NIH附屬人員每三年必須完成一次課程，以確保所有研究人員隨時(shí)了解GCP的發(fā)展情況潮模，如聯(lián)邦法規(guī)中關(guān)于保護(hù)弱勢研究參與者亮蛔、電子數(shù)據(jù)或隱私保護(hù)?的變化。我們鼓勵其他人咨詢和遵守其制度再登，監(jiān)管和其他監(jiān)督委員會的重新認(rèn)證?要求尔邓。

Part 2: The 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.

良好臨床實(shí)踐（GCP）指南是與國際協(xié)調(diào)理事會（ICH）聯(lián)合制定的晾剖。GCP指南綜合了早期醫(yī)療道德規(guī)范中規(guī)定的許多相同原則，為公平梯嗽、科學(xué)合理地開展涉及人類參與者的研究提供了框架齿尽。1996年6月10日發(fā)布的ICH GCP（R1）指南于1997年在《美國聯(lián)邦公報(bào)》上公布，并于2016年11月9日修訂為R2版灯节。這些指南適用于所有涉及人類研究參與者的研究循头。

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指南的目的有兩個：

?· 確保臨床試驗(yàn)參與者的權(quán)利、安全和保密受到保護(hù)炎疆。

?· 確保臨床試驗(yàn)中收集的數(shù)據(jù)以及報(bào)告的臨床試驗(yàn)結(jié)果準(zhǔn)確可信卡骂。

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.

本指南中的原則可適用于所有涉及人類參與者的臨床研究，如涉及研究產(chǎn)品形入、上市藥物全跨、醫(yī)療器械或行為干預(yù)的臨床研究。

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.

《聯(lián)邦法規(guī)法典》（CFR）是美國政府行政部門和機(jī)構(gòu)在《聯(lián)邦公報(bào)》中公布的規(guī)則的編纂（系統(tǒng)安排）亿遂。良好臨床實(shí)踐原則（GCP）編入CFR的幾個章節(jié)或標(biāo)題中浓若。不遵守這些規(guī)定可能導(dǎo)致研究暫停以及罰款和處罰。

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:

參與臨床試驗(yàn)的研究人員和臨床醫(yī)生至少需要熟悉CFR的以下章節(jié)蛇数，這些章節(jié)與涉及人類參與者的研究直接相關(guān)：

[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】本節(jié)規(guī)定了使用電子數(shù)據(jù)采集系統(tǒng)時(shí)電子數(shù)據(jù)和電子簽名的處理挪钓。它由美國食品和藥物管理局（FDA）強(qiáng)制執(zhí)行。有關(guān)21 CFR 11的更多信息耳舅，請單擊此處碌上。

[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】本節(jié)由FDA強(qiáng)制執(zhí)行，規(guī)定了知情同意程序浦徊，規(guī)定了知情同意的要素馏予、一般要求的例外情況以及其他相關(guān)信息。（參見知情同意模塊中的相關(guān)材料）有關(guān)21 CFR 50的更多信息盔性，請單擊此處吗蚌。

[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】本節(jié)由FDA強(qiáng)制執(zhí)行，規(guī)范調(diào)查人員的利益沖突纯出。更多關(guān)于21 CFR 54的信息，請點(diǎn)擊這里敷燎。

[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】本節(jié)由FDA強(qiáng)制執(zhí)行暂筝，規(guī)定了機(jī)構(gòu)審查委員會（IRB）的成員、職責(zé)和運(yùn)作硬贯。（參見機(jī)構(gòu)審查委員會模塊中的相關(guān)材料）有關(guān)21 CFR 56的更多信息焕襟，請單擊此處。

[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】本節(jié)由FDA強(qiáng)制執(zhí)行饭豹，規(guī)定了涉及使用試驗(yàn)新藥的研究行為鸵赖。（參見研究新藥模塊的相關(guān)資料）有關(guān)21 CFR 312的更多信息务漩，請單擊此處。

[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】本節(jié)由FDA強(qiáng)制執(zhí)行它褪，規(guī)定了新藥批準(zhǔn)的申請程序饵骨。有關(guān)21 CFR 314的更多信息，請單擊此處茫打。

[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】這些是屬于衛(wèi)生和公共服務(wù)部（DHHS）管轄的保密條例居触。第2節(jié)涉及酒精和藥物濫用患者記錄的保密性。第2a節(jié)涉及研究參與者身份的保護(hù)老赤。（請參閱保密和隱私模塊中的相關(guān)資料）有關(guān)42 CFR 2和42 CFR 2a的更多信息轮洋，請單擊此處。

[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】本法規(guī)也適用于機(jī)構(gòu)審查委員會（IRB）的成員抬旺、職能和運(yùn)作弊予。此外，它還包括知情同意的一般要求开财，并為弱勢參與者制定了額外的保護(hù)措施汉柒。本法規(guī)的子部分A也稱為通用規(guī)則。最近進(jìn)行了修訂床未，將于2018年生效竭翠。B、C和D子部分包括研究中針對孕婦薇搁、兒童和囚犯的規(guī)定斋扰。它由DHHS人類研究保護(hù)辦公室執(zhí)行。有關(guān)45 CFR 46的更多信息啃洋，請單擊此處传货。

[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】這些是健康保險(xiǎn)攜帶和責(zé)任法案（HIPAA）隱私規(guī)則，由DHHS民權(quán)辦公室執(zhí)行宏娄。

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).

涉及使用受管制物質(zhì)的研究必須符合美國藥品管理局（DEA）條例（21 CFR 1300）问裕。

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:

除局長辦公室外（OC），食品和藥物管理局（FDA）還監(jiān)督四個領(lǐng)域的科學(xué)活動孵坚。這些領(lǐng)域包括醫(yī)療產(chǎn)品和煙草粮宛、食品和獸醫(yī)、全球監(jiān)管和政策以及運(yùn)營卖宠。涉及藥物的科學(xué)調(diào)查受FDA規(guī)定的約束巍杈。除了規(guī)范本單元第3部分中提到的試驗(yàn)新藥（21 CFR 312）的使用和藥物的營銷（21 CFR 314），F(xiàn)DA法規(guī)還適用于良好生產(chǎn)規(guī)范（GMP）扛伍，例如：

[21 CFR 210] Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs;?

【21 CFR 210】制造筷畦、加工、包裝或貯存藥物的現(xiàn)行優(yōu)良制造規(guī)范;

[21 CFR 211] Current Good Manufacturing Practice for Finished Pharmaceuticals.

【21 CFR 211】成品藥品的現(xiàn)行良好生產(chǎn)規(guī)范刺洒。

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).

另一項(xiàng)聯(lián)邦法律是《健康保險(xiǎn)可攜帶性和責(zé)任法案》（HIPAA）隱私規(guī)則和HIPAA安全規(guī)則鳖宾，保護(hù)研究參與者及其個人健康信息的隱私吼砂。（HIPAA在保密和隱私模塊第8部分中有更詳細(xì)的討論）。

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

美國國家衛(wèi)生研究院的政策規(guī)范了補(bǔ)助金的管理鼎文。更多關(guān)于國家衛(wèi)生研究院補(bǔ)助金政策的信息渔肩，請參考網(wǎng)站。

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.

國家漂问、州赖瞒、城市和機(jī)構(gòu)可以實(shí)施額外的政策來保護(hù)人類參與者。這些政策可能會提出比聯(lián)邦法規(guī)更嚴(yán)格的要求蚤假。如果制定了更嚴(yán)格的當(dāng)?shù)厝祟悈⑴c者保護(hù)政策栏饮，研究人員必須始終確保其研究的設(shè)計(jì)和實(shí)施符合當(dāng)?shù)睾吐?lián)邦要求。

Part 4: Summary of Key Points

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磷仰、良好臨床實(shí)踐（GCP）是臨床試驗(yàn)設(shè)計(jì)袍嬉、實(shí)施、績效灶平、監(jiān)測伺通、審計(jì)、記錄逢享、分析和報(bào)告的國際倫理和科學(xué)標(biāo)準(zhǔn)罐监。本標(biāo)準(zhǔn)保證：

（1）試驗(yàn)參與者的權(quán)利、安全瞒爬、福利和保密性受到保護(hù)弓柱。

（2）臨床試驗(yàn)中收集的數(shù)據(jù)以及臨床試驗(yàn)報(bào)告的結(jié)果是可信和準(zhǔn)確的。

Ⅱ侧但、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矢空、目前的良好臨床實(shí)踐體系的發(fā)展，在某種程度上是為了應(yīng)對過去研究參與者受到嚴(yán)重虐待的事件禀横。

Ⅲ屁药、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、《良好臨床實(shí)踐指南》為公平柏锄、科學(xué)合理地開展涉及人類參與者的研究提供了框架酿箭。因此，所有試驗(yàn)都應(yīng)按照良好臨床實(shí)踐（GCP）進(jìn)行趾娃，所有研究人員都應(yīng)接受培訓(xùn)七问，并保持GCP的最新狀態(tài)。

Ⅳ茫舶、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、向國家衛(wèi)生研究院提交涉及人類研究參與者的競爭性或非競爭性項(xiàng)目申請的所有關(guān)鍵人員刹淌，必須接受保護(hù)人類研究參與者的培訓(xùn)饶氏。

Ⅴ讥耗、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、《聯(lián)邦法規(guī)法典》（CFR）是美國政府行政部門和機(jī)構(gòu)在《聯(lián)邦公報(bào)》中公布的規(guī)則的編纂（系統(tǒng)安排）疹启。良好臨床實(shí)踐的原則在CFR的幾個章節(jié)或標(biāo)題中進(jìn)行了編碼古程。不遵守這些規(guī)定可能導(dǎo)致研究暫停以及罰款和處罰。

Ⅵ喊崖、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挣磨、國家、州荤懂、城市和機(jī)構(gòu)可以實(shí)施額外的政策來保護(hù)人類參與者茁裙。這些政策可能會提出比聯(lián)邦法規(guī)更嚴(yán)格的要求。如果制定了更嚴(yán)格的當(dāng)?shù)厝祟悈⑴c者保護(hù)政策节仿，研究人員必須始終確保其研究的設(shè)計(jì)和實(shí)施符合當(dāng)?shù)睾吐?lián)邦要求晤锥。