FDA 21 CFR 812 IDE 中文简译 (fda临床试验规定)

PART812—INVESTIGATIONAL

DEVICE EXEMPTIONS

调查的机械豁免

Subpart A—General Provisions

Sec.

812.1Scope.范围

812.2Applicability.申请

812.3Definitions.定义

812.5Labeling of investigational devices.标记调查用的机械

812.7Prohibition of promotion and other practices.推广的禁用和实行812.10Waivers.豁免

812.18Import and export requirements.进口和出口的需求。

812.19Address for IDE correspondence.IDE对应的定位

Subpart B—Application and Administrative Action部分B-申请程序和行政诉讼

812.20Application.申请,申請內容

812.25Investigational plan.研究计划

812.27Report of prior investigations.前调查报告(临床前报告)

812.30FDA action on applications.FDA的申请程序上的行动

812.35Supplemental applications.补充申请

812.36Treatment use of an investigational device.研究机械的处方

812.38Confidentiality of data and information.数据和信息的保密性。

Subpart C—Responsibilities of Sponsors对厂商的责任分部C

812.40General responsibilities of sponsors.厂商的一般责任

812.42FDA and IRB approval.FDA和IRB的批准

812.43Selecting investigators and monitors.选择的调查和监控。

812.45Informing investigators.告知调查。

812.46Monitoring investigations.监测调查。

812.47Emergency research under§50.24of this chapter.紧急研究

Subpart D—IRB Review and Approval分部D-IRB的审查和批准

812.60IRB composition,duties,and functions.IRB组成，职责和功能

812.62IRB approval.IRB的批准。

812.64IRB’s continuing review.IRB的持续检讨

812.65[Reserved][修改中]

812.66Significant risk device determinations.重大危险设备的确定

Subpart E—Responsibilities of Investigators研究者的责任

812.100General responsibilities of investigators.研究者的一般责任

812.110Specific responsibilities of investigators.研究者的特殊责任

812.119Disqualification of a clinical investigator.被取消资格的临床研究者

§812.1Scope.

(a)The purpose of this part is to encourage,to the extent consistent with the

protection of public health and safety and with ethical standards,the discovery and development of useful devices intended for human use,and to that end to maintain optimum freedom for scientific investigators in their pursuit of this purpose.

一）这部分的目的是要鼓励，保护公众健康和安全，道德标准，发现和开发有用的设备用于人类使用的相一致的程度，并为此目的，以保持最佳的自由科学的研究人员在他们的追求自己的目标。

(b)This part provides procedures for the conduct of clinical investigations of

devices.An approved investigational device exemption(IDE)permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device.An IDE approved under§812.30or considered approved under§812.2(b)exempts a device from the requirements of the following sections of the Federal Food,Drug,and Cosmetic Act(the act)and regulations issued thereunder:Misbranding under section502of the act, registration,listing,and premarket notification under section510, performance standards under section514,premarket approval under section515,

a banned device regulation under section516,records and reports under section

519,restricted device requirements under section520(e),good manufacturing practice requirements under section520(f)except for the requirements found in§820.30,if applicable(unless the sponsor states an intention.to comply with these requirements under§812.20(b)(3)or§812.140(b)(4)(v))and color additive requirements under section721.(b)References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21,unless otherwise noted.[45FR3751,Jan.18,1980,as amended at59FR14366, Mar.28,1994;61FR52654,Oct.7,1996]

（b）本部分提供设备的临床调查程序的行为。经批准的调查装置豁免（IDE）允许的设备，否则将须遵守的绩效标准，或有运合法进行调查的目的，该设备的上市前批准。根据§812.30批准的IDE或审议批准，根据§812.2（b）豁免的设备“联邦食品，药品和化妆品法”（该法）和法规据此颁布的以下部分的要求：根据第502Misbranding的行为，登记，上市，上

市前通知，根据第510条，第514的性能标准下，根据第515上市前批准，禁止器械监管，记录和报告根据第519，限制设备的需求，根据第520（E）根据第516，良好生产规范要求，根据第520（f）除§820.30中的要求，如果适用（除非赞助商规定的intention.to符合这些要求根据§812.20（B）（3）或§812.140（B）（4）（V））和第721条的颜色添加剂规定。（二）在这部分的监管部分的联邦法规法典第21章我，除非另有说明。

§812.2Applicability.

(a)General.This part applies to all clinical investigations of devices to determine safety and effectiveness,except as provided in paragraph(c)of this section.

(b)Abbreviated requirements.The following categories of investigations are considered to have approved applications for IDE’s,unless FDA has notified a sponsor under§812.20(a)that approval of an application is required:

（a）一般。本部分适用于所有设备的临床调查，以确定

安全性和有效性，在本节（c）段规定的除外。

（二）缩写的要求。以下类别的调查被认为是IDE的已批准的申请程序，除非FDA已通知申请商根据§812.20（a）在批准申请要求：

1）调查的其他设备

比重大的风险的移动设备，如果该设备是不是一个被禁止的设备和赞助商：

（一）按照标签设备

§812.5;

（二）调查获得IRB的批准后提出审查IRB简要说明所以，该设备是不是一个显著的风险设备，并能保持这样的批准;

（三）确保每个调查参与调查设备获取从每个主题下研究者的关怀下，知情同意

根据第50部分和文件，除非文档免除其IRB根据§56.109（C）。

（四）符合要求

(iv)Complies with the requirements of§812.46with respect to monitoring investigations;

(v)Maintains the records required under§812.140(b)(4)and(5)and makes the reports required under§812.150(b)(1)through(3)and(5)through(10);

(vi)Ensures that participating investigators maintain the records required by§812.140(a)(3)(i)and make the reports required under§812.150(a)(1),(2),(5), and(7);and

(vii)Complies with the prohibitions in§812.7against promotion and other practices.

(2)An investigation of a device other than one subject to paragraph(e)of this

section,if the investigation was begun on or before July16,1980,and to be completed,and is completed,on or before January19,1981.

(c)Exempted investigations.

This part,with the exception of§812.119,does not apply to investigations of the

following

categories of devices:

(1)A device,other than a transitional device,in commercial distribution immediately before May28,1976,when used or investigated in accordance with the indications in labeling in effect at that time.

(2)A device,other than a transitional device,introduced into commercial distribution on or after May28,1976,that FDA has determined to be substantially equivalent to a device in

commercial distribution immediately before May28,1976,and that is used or investigated in accordance with the indications in the labeling FDA reviewed under subpart E of part807in determining substantial equivalence.

§812.119例外，这部分并不适用于以下调查

的设备的类别：

1.一个仪器，一个过渡性的装置以外，在商业分销紧接之前5月28日，1976年，使用时根据当时的效果上的指示标签或调查。

2.设备，其他比一个过渡性的设备，引入商业流通于1976年5月28日或之后，FDA已经确定设备大致相当于商业分销，立即在1976年5月28日之前，那就是使用或调查审查按照在标签FDA的迹象，下部分807在确定实质等同性条E款。

(3)A diagnostic device,if the sponsor complies with applicable requirements in §809.10(c)and if the testing:

(i)Is noninvasive,

(ii)Does not require an invasive sampling procedure that presents significant risk, (iii)Does not by design or intention introduce energy into a subject,and (iv)Is not used as a diagnostic procedure without confirmation of the diagnosis by another,medically established diagnostic product or procedure.

(4)A device undergoing consumer preference testing,testing of a modification,or

testing of a combination of two or more devices in commercial distribution,if the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk.

(5)A device intended solely for veterinary use.

(6)A device shipped solely for research on or with laboratory animals and labeled

in accordance with§812.5(c).

(7)A custom device as defined in§812.3(b),unless the device is being used to

determine safety or effectiveness for commercial distribution.

的诊断设备，如果申请商符合适用§809.10（c）和测试要求：

1.非侵入性，

2.并无需要侵入性的抽样程序，呈现显著的风险，

3.不设计或意图引进能源成主题，

4.不使用作为一个诊断过程没有诊断确认，另一位医学诊断产品或程序。

4.的移动设备接受消费者的喜好的测试，测试的变形，或在商业销售中的两个或多个设备的组合的测试，如果测试是不是为目的确定安全性或有效性，不把风险科目。

5.设备仅供兽医使用

6.设备运仅用于研究或实验动物，并按照§812.5（三）标记。

7.§812.3（b）条所界定的定制设备，除非设备被用来确定商业流通的安全性或有效性。

(d)Limit on certain exemptions.

In the case of class II or class III device described in paragraph(c)(1)or(2) of this section,this part applies beginning on the date stipulated in an FDA regulation or order that calls for the submission of premarket approval applications for an unapproved class III device,or establishes a performance standard for a class II device.

（四）某些豁免的限制。

本节段所描述的II类或III类设备（三）（1）或（2）的情况下，本部分适用之日起，FDA法规或命令，要求提交的上市前批准申请规定未经批准的第三类设备，或建立一个II类设备的性能标准。

(e)Investigations subject to IND’s.A

sponsor that,on July16,1980,has an effective investigational new drug application (IND)for an investigation of a device shall continue to comply with the requirements of part312until90days after that date.To continue the investigation after that date,a sponsor shall comply with paragraph(b)(1)of this section,if the device is not a significant risk device,or shall have obtained FDA approval under§812.30 of an IDE application for the investigation of the device.

（五）新药申请的受试者

赞助商，1980年7月16日，有一个有效的研究新药申请（IND）的设备进行调查，直到该日期后90日内，将继续遵守与312部分的要求。要继续调查，在该日期之后，赞助商应符合本节（b）段（1），如果该设备不是一个显著风险装置，或已获得美国食品和药物管理局的批准，根据§812.30IDE申请调查设备。

§812.3Definitions.

(a)Act means the Federal Food,Drug,and Cosmetic Act(sections201–

901,52Stat.1040et seq.,as amended(21U.S.C.301–392)).

(b)Custom device means a device that:

(1)Necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician or dentist;

(2)Is not generally available to,or generally used by,other physicians or dentists;

(3)Is not generally available in finished form for purchase or for dispensing upon prescription;

(4)Is not offered for commercial distribution through labeling or advertising;and

(5)Is intended for use by an individual patient named in the order of a physician or dentist,and is to be made in a specific form for that patient,or is intended to meet the special needs of

the physician or dentist in the course of professional practice.

(c)FDA means the Food and Drug Administration.

(d)Implant means a device that is placed into a surgically or naturally formed cavity of the human body if it

§812.5Labeling of investigational devices.

(a)Contents.

An investigational device or its immediate package shall bear a label with the following information:

the name and place of business of the manufacturer,packer,or distributor(in accordance with§801.1),the quantity of contents,if appropriate,and the following statement:

‘‘CAUTION—Investigational device.Limited by Federal(or United States)law to investigational use.’’The label or other labeling shall describe all relevant contraindications,hazards,adverse

effects,interfering substances or devices,warnings,and precautions.

(b)Prohibitions.

The labeling of an investigational device shall not bear any statement that is false or misleading in

any particular and shall not represent that the device is safe or effective for the purposes for which it is being investigated.

(c)Animal research.

An investigational device shipped solely for research on or with laboratory animals shall bear on its label the following statement:‘‘CAUTION—Device for investigational use in laboratory animals or other tests that do not involve human subjects.’’

§812.5贴标研究设备。

内容。调查装置或其直接包装上须标示以下信息：

的名称和业务的制造商，包装商或分销商（按照§801.1），内容量，如果适当的话，下面的语句：

当心调查设备。有限公司由联邦（或美国）法律研究使用。标签或其他标记应描述所有相关的禁忌症，危害，不利影响，干扰物质或装置，警告和注意事项。

（二）禁止。

上属虚假或具误导性的研究设备的标签不承担任何声明不得代表任何特定的目的，它正在调查该设备是安全的或有效。

（三）对动物的研究。

一个仅用于研究或实验动物研究设备运在其标签上应承担以下声明：“注意用于研究在实验室动物或其他不涉及人类受试者的测试设备。(只能用于动物)

§812.7Prohibition of promotion and other practices.

A sponsor,investigator,or any person acting for or on behalf of a sponsor or investigator shall not:

(a)Promote or test market an investigational device,until after FDA has approved

the device for commercial distribution.

(b)Commercialize an investigational device by charging the subjects or

investigators for a device a price larger than that necessary to recover costs of manufacture,research,development,

and handling.

(c)Unduly prolong an investigation.If data developed by the investigation indicate

in the case of a class III device that premarket approval cannot be justified or in the case of a class II device

that it will not comply with an applicable performance standard or an amendment to that standard,the sponsor shall promptly terminate the investigation. (d)Represent that an investigational device is safe or effective for the purposes

for which it is being investigated.

禁止宣传等做法。

申请商，研究员，或行事的任何人或代表的申请商或研究者不得：

（一）促进或测试市场调查装置，直到FDA已经批准了该设备用于商业分布后。

（二）商业化的研究设备充电设备价格大于必要的生产，研究，开发收回成本的科目或调查，和处理。

（三）不适当地延长了调查。如果开发调查数据表明在Ⅲ类的移动设备不能自圆其说或II 类设备的情况下，上市前批准的情况下，它不会遵守适用的性能标准或修订该标准，保荐机构应当及时终止调查。

（四）代表，它正在调查的目的是安全的或有效的研究设备。

§812.10Waivers.

(a)Request.A sponsor may request FDA to waive any requirement of this

part.A waiver request,with supporting documentation,may be submitted separately or as part of an application to the address in§812.19.

(b)FDA action.FDA may by letter grant a waiver of any requirement that FDA finds is not required by the act and is unnecessary to protect the rights,safety,or welfare of human subjects.

(c)Effect of request.Any requirement shall continue to apply unless and until FDA

waives it.

（一）申请。申请商可能会要求FDA放弃任何要求的一部分。的豁免请求，支持文档，可单独提交或者作为一个申请到的地址§812.19中的一部分。

（二）FDA的行动。信，FDA可能授出豁免的任何规定，FDA发现不要求行为是不必要的，以保护人类受试者的权利，安全或福利。

（三）要求的影响。任何要求，应继续适用，除非及直至FDA放弃。

§812.18Import and export requirements.

(a)Imports.In addition to complying with other requirements of this part,a person who imports or offers for importation an investigational device subject to this part shall be the agent of the foreign exporter with respect to investigations of the device and shall act as the sponsor of the clinical investigation,or ensure that another person acts as the agent of the foreign exporter and the sponsor of the investigation.

(b)Exports.A person exporting an investigational device subject to this

part shall obtain FDA’s prior approval,as required by section801(e)of the act or comply with section802of the act.

（一）进口。除符合本部分要求，人谁进口或提供进口设备研究课题在这一部分应当是代理国外出口商调查设备和作为申请商的临床调查，或确保其他人充当代理国外出口商和赞助商的调查。

（二）出口。一个人出口受调查装置

部分应事先获得FDA的批准，第801（e）条的行为所要求的或符合该法案第802节。

Subpart B—Application and

Administrative Action

§812.20Application.

(a)Submission.

(1)A sponsor shall submit an application to FDA if the sponsor intends to use a significant risk device in an investigation,intends to conduct an investigation that involves an exception from informed consent under§50.24of this chapter, or if FDA notifies the sponsor that an application

is required for an investigation.

(2)A sponsor shall not begin an investigation for which FDA’s approval of an application is required until FDA has approved the application.

(3)A sponsor shall submit three copies of a signed‘‘Application for an Investigational Device Exemption’’(IDE application),together with accompanying materials,by registered mail or by hand to the address in§812.19.Subsequent correspondence concerning an application or a supplemental application shall be

submitted by registered mail or by hand.

a）提交。

（1）如果赞助商拟使用显著的风险设备在进行调查中，申请商应当向FDA提交申请，拟进行的调查，涉及到一个异常知情同意根据本章§50.24，如果FDA通知保荐一个应用程序需要进行调查。

2.申请商应当展开调查，FDA批准应用程序的需要，直到FDA已经批准了该应用程序。

（3）申请商应当提交3份签署的“应用的调查设备豁免（IDE应用程序），连同随行材料，通过挂号邮件或手§812.19中的地址。后续对应一个应用程序或补充申请，应当提交由挂号邮件或手。

(i)A sponsor shall submit a separate IDE for any clinical investigation involving

an exception from informed consent under§50.24of this chapter.Such a clinical investigation is not permitted to proceed without the prior written authorization of FDA.FDA shall provide a written determination30days after FDA receives the IDE or earlier.

(ii)If the investigation involves an exception from informed consent under§50.24 of this chapter,the sponsor shall prominently identify on the cover sheet that the investigation is subject

to the requirements in§50.24of this chapter.

（1）申请商应当提交任何临床调查，根据§50.24本章涉及知情同意的例外一个单独的IDE。这种临床调查，不允许进行未经事先书面授权，FDA。FDA应提供的书面决定后30日内FDA 收到的IDE或更早。

（2）若调查根据§50.24本章涉及知情同意的例外，申请商应突出封面上确定调查本章§50.24中的要求。

(b)Contents.An IDE application shall include,in the following order:

(1)The name and address of the sponsor.

(2)A complete report of prior investigations of the device and an accurate summary

of those sections of the investigational plan described in§812.25(a)through

(e)or,in lieu of the summary,the complete plan.The sponsor shall submit to

FDA a complete investigational plan and a complete report of prior investigations of the device if no IRB has reviewed them,if FDA has found an IRB’s review inadequate,or if FDA requests them.

(3)A description of the methods,facilities,and controls used for the manufacture,

processing,packing,storage,and,where appropriate,installation of the device, in sufficient detail so that a person generally familiar with good manufacturing

practices can make a knowledgeable judgment about the quality control used in the manufacture of the device.

(4)An example of the agreements to be entered into by all investigators to comply

with investigator obligations under this part,and a list of the names

(5)A certification that all investigators who will participate in the investigation

have signed the agreement,that the list of investigators includes all the investigators participating in the investigation,and that no investigators will be added to the investigation until they have signed the agreement.

(6)A list of the name,address,and chairperson of each IRB that has been or will

be asked to review the investigation and a certification of the action concerning the investigation taken by each such IRB.

(7)The name and address of any institution at which a part of the investigation

may be conducted that has not been identified in accordance with paragraph(b)(6) of this section.

(8)If the device is to be sold,the amount to be charged and an explanation of why

sale does not constitute commercialization of the device.

(9)A claim for categorical exclusion under§25.30or25.34or an environmental

assessment under§25.40.

(10)Copies of all labeling for the device.

(11)Copies of all forms and informational materials to be provided to subjects to

obtain informed consent.??

(12)Any other relevant information FDA requests for review of the application.

内容。IDE申请程序应包括以下顺序：

（1）赞助商的名称和地址。

（2）一个完整的事先调查报告§812.25（a）条中描述的研究计划通过这些路段的设备和准确的概括（e）或代替的总结，完整的计划。申请商须提交FDA的一个完整的研究计划和一份完整的报告之前调查的设备，如果没有IRB审查他们，如果FDA已经发现不足，或如果FDA要求他们的IRB审查。

（3）说明用于制造的方法，设施和控制，加工，包装，储存，及在适当情况下，设备的安装，足够的细节，所以一般人熟悉的良好生产规范制造的设备中使用的质量控制可以使一个知识渊博的判断。

（4）所有调查符合研究者的义务根据本部分将予订立的协议的名称，并列出一个例子,列出研究者的清单

（5）认证，已签署协议将参与调查的所有调查谁，调查名单包括所有参与调查的研究者，且没有任何调查调查，直至他们已经签署协议将被添加。

（6）列表的名称，地址，和主席的每个IRB已经或将被要求审查有关调查所采取的每个该等IRB调查和认证的动作。

（7）可以进行的调查的一部分的任何机构的名称和地址，还没有被确定按照第（二）（6）本节。

（8）如果设备要出售，要收取的金额，并解释为什么销售不构成商品化的设备。

（9）要求分类排除根据第25.30或25.34或环境评估根据§25.40。

（10）将所有设备的标签。

（11）各种形式的副本和信息需提供的材料科目，取得知情同意。

（12）任何其他有关资料，FDA要求审查的申请。

(c)Additional information.

FDA may request additional information concerning an investigation or revision in the investigational plan.The sponsor may treat such a request as a disapproval of the application for purposes of requesting a hearing under part16.

(d)Information previously submitted.

Information previously submitted to the Center for Devices and Radiological Health in accordance with this chapter ordinarily need not be resubmitted,but may be incorporated by reference.

（三）其他信息。

FDA可能要求额外的信息有关的调查或研究计划的修订。申办者可对待这样的请求不予部16,下要求举行听证会的目的申请。

（四）以前提交的资料。

按照本章先前提交的器械和辐射健康中心的信息通常不需要重新提交，但可纳入参考。

The investigational plan shall include,in the following order:

(a)Purpose.

The name and intended use of the device and the objectives and duration of the investigation.

(b)Protocol.

A written protocol describing the methodology to be used and an analysis of the protocol demonstrating that the investigation is scientifically sound.

(c)Risk analysis.

A description and analysis of all increased risks to which subjects will be exposed by the investigation;the manner in which these risks will be minimized;a justification for the investigation;and a description of the patient population, including the number,age,sex,and condition.

(d)Description of device.

A description of each important component,ingredient,property,and principle of operation of the device and of each anticipated change in the device during the course of the investigation.

(e)Monitoring procedures.

The sponsor’s written procedures for monitoring the investigation and the name and address of any monitor.

(f)Labeling.

Copies of all labeling for the device.

(g)Consent materials.

Copies of all forms and informational materials to be provided to subjects to obtain informed

Consent.

(h)IRB information.

A list of the names,locations,and chairpersons of all IRB’s that have been or will be

asked to review the investigation,and a certification of any action taken by any of those IRB’s with respect to the investigation.

(i)Other institutions.

The name and address of each institution at which a part of the investigation may be conducted

that has not been identified in paragraph(h)of this section.

(j)Additional records and reports.

A description of records and reports that will be maintained on the investigation in addition to those prescribed in subpart G.

研究计划应包括以下顺序：

1.目的。

名称和预期用途的移动设备的目标和在临床期间。

2.协议。

一份书面的协议描述要使用的方法，并分析调查表明科学合理的协议。

3.风险分析。

科目将被暴露，经查所有的风险增加，将减少这些风险的方式;调查的理由，并说明患者群体，包括数量，年龄，性别的描述与分析，和条件。

4.设备描述。

每一个重要的组成部分，成分，属性，和器件的工作原理的描述，并在设备内，调查过程中的每一个预期的变化。

5.监测程序。

赞助商的书面程序监测调查的名称和地址的任何显示器。

6.标签。

复制所有标签设备。

7.同意材料。

各种形式和宣传材料的副本提供给对象获得知情同意。

8.IRB信息。

列表的名称，位置和IRB的所有已经或将主席要求审查的调查，调查方面采取的任何行动的任何该等IRB认证。

9.其他机构。

可能进行的调查的一部分，每个机构的名称和地址尚未确定在本节（h）段。

10.条附加记录和报告。

将保持记录和报告的调查说明除了所规定分部G中

§812.27Report of prior investigations.

(a)General.The report of prior investigations shall include reports of all prior clinical,animal,and laboratory testing of the device and shall be comprehensive and adequate to justify the proposed investigation.

(b)Specific contents.The report also shall include:

(1)A bibliography of all publications,whether adverse or supportive,that are relevant to an evaluation of the safety or effectiveness of the device,copies of all published and unpublished adverse information,and,if requested by an IRB or FDA,copies of other significant publications.

(2)A summary of all other unpublished information(whether adverse or supportive) in the possession of,or reasonably obtainable by,the sponsor that is relevant to an evaluation of the safety or effectiveness of the device.

(3)If information on nonclinical laboratory studies is provided,a statement that all such studies have been conducted in compliance with applicable requirements in the good laboratory practice regulations in part58,or if any such study was not conducted in compliance with such regulations,a brief statement of the reason for the noncompliance.Failure or inability to comply with this requirement does not justify failure to provide information on a relevant nonclinical test study.

§812.27前调查报告。

（a）一般。前调查报告应包括所有的报告,前临床，动物，和实验室测试的设备应是全面的足以证明所拟调查。

（b）特定的内容。该报告还应当包括：

书目的所有出版物，是否不良或支持，相关的设备的安全性或有效性的评估，将所有已发布和未发布的不良信息，而且，如果由IRB或FDA要求的其他重要出版物的副本。

摘要中占有所有其他未公开的信息（无论是不利或支持），或可合理获得通过，申请商，相关的设备的安全性或有效性评价。如果提供非临床实验室研究的信息，所有此类研究已进行符合适用要求的良好实验室规范法规第58部分，或者如果符合该等规定则没有进行任何此类研究的声明，一份简短的声明违规的原因。失败或无法遵守这项规定没有理由未能提供相关的非临床试验研究的信息。

§812.30FDA action on applications.

(a)Approval or disapproval.FDA will notify the sponsor in writing of the date it receives an application.FDA may approve an investigation as proposed,approve it with modifications,or disapprove it.An investigation may not begin until:

(1)Thirty days after FDA receives the application at the address in§812.19 for the investigation of a device other than a banned device,unless FDA notifies the sponsor that the investigation may not begin;or

(2)FDA approves,by order,an IDE for the investigation.

(b)Grounds for disapproval or withdrawal.FDA may disapprove or withdraw approval of an application if FDA finds that:

(1)There has been a failure to comply with any requirement of this part or

the act,any other applicable regulation Regulation or statute,or any condition of approval

imposed by an IRB or FDA.

(2)The application or a report contains an untrue statement of a material fact,or omits material information required by this part.

(3)The sponsor fails to respond to a request for additional information

within the time prescribed by FDA.

(4)There is reason to believe that the risks to the subjects are not outweighed by the anticipated benefits to the subjects and the importance of the knowledge to be gained,or informed consent is inadquate,or the investigation is scientifically unsound,or there

is reason to believe

§812.30FDA的行动申请。

批准或不批准。FDA将收到申请的日期的书面通知申请商。FDA可能批准调查的提议，同意修改或否决。调查可能不会开始，直到：

（1）30天之后，FDA收到申请的地址§812.19禁止的设备以外的其他设备进行调查，除非FDA通知申请商的调查可能不会开始;FDA批准，秩序，调查的IDE。

（二）反对或撤销的理由。FDA可能否决或撤销

批准申请，如果FDA发现：

（1）一直以来未能遵守本部分的任何规定或的行为，任何其他适用法规条例或法规，或批准的任何条件IRB或FDA施加。

（2）申请程序或报表中包含的材料不真实的陈述事实上，或省略这部分所需的重要资料。（3）申请商无法回应请求更多信息规定的时间内通过美国FDA。

（4）有有理由相信，受试者的风险不超过预期效益科目的重要性要获得的知识，或通知的同意是inadquate的，或调查是不科学的，或者有有理由相信设备使用的是无效的.

(5)It is otherwise unreasonable to begin or to continue the investigation owing to the way in which the device is used or the inadequacy of:

(i)The report of prior investigations or the investigational plan;

(ii)The methods,facilities,and controls used for the manufacturing,processing, packaging,storage,and,where appropriate,installation of the device;Or (iii)Monitoring and review of the investigation.

（5）否则是不合理的开始或继续进行调查由于的方式，该设备是用于或的不足之处：（i）前调查或研究计划的报告;

（ii）本方法，设施，用于制造，加工和控制,包装，储存，以及在适当的情况下，设备的

安装，或者

（iii监测和复审调查。

(c)Notice of disapproval or withdrawal.If FDA disapproves an application or proposes to withdraw approval of an application,FDA will notify the sponsor in writing.

(1)A disapproval order will contain a complete sttement of the reasons for disapproval and a statement that the sponsor has an opportunity to request a hearing under part16.

(2)A notice of a proposed withdrawal of approval will contain a complete statement of the reasons for withdrawal and a statement that the sponsor has an opportunity to request a hearing under part16.FDA will provide the opportunity for hearing before withdrawal of approval,unless FDA determines in the notice that continuation of testing under the exemption will result in an unreasonble risk to the public health and orders withdrawal of approval before any hearing.

（三）股东的反对或撤销。如果FDA不批准的申请程序或拟撤回批准申请，FDA会以书面形式通知申请商。

（1）反对令将包含一个完整的sttement不赞成的原因和申请商有要求举行听证的机会部16下一份声明中说。

（2）一事一议的通知，撤回批准将撤回的原因和声明，声明包含一个完整的申请商有要求举行听证的机会下一部分16。FDA将提供机会听到撤回批准前，除非FDA的声明中确定继续测试下的豁免将导致公众健康和批准任何听证会前的订单撤离风险unreasonble的。

§812.35Supplemental applications.

(a)Changes in investigational plan—

(1)Changes requiring prior approval.Except as described in paragraphs(a)(2) through(a)(4)of this section,a sponsor must obtain approval of a supplemental application under§812.30(a),and IRB approval when appropriate(see§§56.110 and56.111of this chapter),prior to implementing a change to an investigational plan.If a sponsor intends

to conduct an investigation that involves an exception to informed consent under §50.24of this chapter,the sponsor shall submit a separate investigational device exemption(IDE)application

in accordance with§812.20(a).

§812.35补充申请。

（一）研究计划（1）需要事先获得批准。除上文所述者在上文（a）（2）（a）通过本节（4），申请商必须取得批准的补充在适当的时候根据§812.30（a）条，申请程序和IRB批准（见§§56.110和56.111本章），前执行变更研究计划。如果打算赞助商进行调查，根据§50.24本章涉及知情同意的例外，申请商须提交一份单独的调查设备豁免（IDE）中的申请

按照§812.20（a）条。

(2)Changes effected for emergency use.

The requirements of paragraph(a)(1)of this section regarding FDA approval of a supplement do not apply in the case of a deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency.

Such deviation shall be reported to FDA within5-working days after the sponsor learns of it(see§812.150(a)(4)).

（2）变化，以备不时之需。上文（a）（1）本条就FDA批准的补充要求并不适用于研究计划有偏差的情况下，从保护平民的生命或身体的福祉在紧急情况下一个主题。

这种偏差应在5个工作日内报告给FDA赞助商后得知，（见§812.150（一）（4））。

(3)Changes effected with notice to FDA within5days.A sponsor may make certain changes without prior approval of a supplemental application under paragraph(a)(1) of this section if the sponsor determines that these changes meet the criteria described in paragraphs

(a)(3)(i)and(a)(3)(ii)of this section,on the basis of credible information defined in paragraph(a)(3)(iii)of this section,and the sponsor provides notice to FDA within5-working days of making these changes.

（3）变化，5天之内通知FDA。

申请商可作出某些如果赞助商决定更改而不事先批准补充申请根据上文（a）（1）本节，这些变化符合条件的段落中描述（一）（3）（i）及（一）（3）（2）本节的基础上，可靠的信息定义见下文（一）（3）（三）本节中，与申请商提供的通知FDA在5个工作日内作出上述改变。

(i)Developmental changes.The requirements in paragraph(a)(1)of this section regarding FDA approval of a supplement do not apply to developmental changes in the device(including manufacturing changes)that do not constitute a significant change in design or basic principles of operation and that are made in response to information gathered

（一）发展变化。上文（a）（1）FDA批准的补充设备（包括制造业的变化）的发展变化不构成重大的变化，设计或操作的基本原则并不适用于本条就要求在收集到的信息

(ii)Changes to clinical protocol.The requirements in paragraph(a)(1)of this section regarding FDA approval of a supplement do not apply to changes to clinical protocols that do not affect:

The validity of the data or information resulting from the completion of the approved protocol,or the relationship of likely patient risk to benefit relied upon to approve the protocol;(B)The scientific soundness of the investigational plan;or (C)The rights,safety,or welfare of

the human subjects involved in the investigation.

（二）临床协议。上文（a）（1）本条就FDA批准的补充规定并不适用于临床协议不影响：从批准的协议完成的数据或信息，或病人可能的风险，受益赖以批准该协议的关系，（B）研究计划的科学合理性，或（C）的权利的有效性，安全或福利在调查涉及人类受试者。

(iii)Definition of credible information.(A)Credible information to support developmental

changes in the device(including manufacturing changes)includes data generated under the design

control procedures of§820.30,preclinical/animal testing,peer reviewed published literature,or other reliable information such as clinical information gathered during a trial or marketing.

（三）定义可信的信息。（

A），可靠的信息支持发展的变化在设备中（包括生产变化）包括根据该设计中产生的数据§820.30，临床前/动物试验控制程序，同行评审发表的文献，如临床审讯或营销过程中收集的信息或其他可靠的信息。

(B)Credible information to support changes to clinical protocols is defined as the sponsor’s documentation supporting the conclusion that a change does not have a significant impact on

the study design or planned statistical analysis,and that the change does not affect the rights,safety,or welfare of the subjects.Documentation shall include information such as peer reviewed

published literature,the recommendation of the clinical investigator(s),and/or the data gathered during the clinical trial or marketing.

（B）被定义为可信的信息，以支持临床协议的变更赞助商的支持改变的结论是没有重大影响的档研究设计或计划的统计分析，以及该变化不会影响受试者的权利，安全或福利。档应包括的信息，如同行评审公开发表的文献，临床研究者（S），和/或临床试验或营销过程中收集到的数据的建议。

(iv)Notice of IDE change.Changes meeting the criteria in paragraphs(a)(3)(i)and (a)(3)(ii)of this section that are supported by credible information as defined in paragraph(a)(3)(iii)

of this section may be made without prior FDA approval if the sponsor submits a notice of the change to the IDE not later than5-working days after making the change. Changes to devices

are deemed to occur on the date the device,manufactured incorporating the design or manufacturing change,is distributed to the investigator(s).Changes to a clinical protocol are deemed to occur when a clinical investigator is notified by the sponsor that the change should be implemented in the protocol or,for sponsor-investigator studies,when a sponsor-investigator incorporates the change in the protocol.Such notices shall be identified as a‘‘notice of IDE change.’’

（四）公告IDE变化。符合条件的变化，在第（一）（3）（i）及（3）（A）（3）（ii）条本节，可靠的信息支持（a）段所界定的（三）本节，恕不另行FDA的批准，如果申请商提交的变更通知不得迟于5个工作日内作出更改后的IDE。变更设备被视为发生的日期的移动设备，制造结合的设计或制造上的变化，分布的研究者（次）。被视为临床协议的变更通知申请商的变化应在协议或的赞助调查研究，当一个申办者-研究者在协议中采用的变化发生时，临床研究者。这种通知应被认定为一个“通知IDE变化。

(A)For a developmental or manufacturing change to the device,the noticeshall include a summary of the relevant information gathered during the course of the investigation upon which

the change was based;a description of the change to the device or manufacturing process(cross-referenced to the appropriate sections of the original device description or manufacturing

process);and,if design controls were used to assess the change,a statement that no new risks were identified by appropriate risk analysis and that the verification and validation testing,as

appropriate,demonstrated that the design outputs met the design input requirements. If another method of assessment was used,the notice shall include a summary of the information which served as the credible information supporting the change.

(A)发展或制造变化的设备，的notices hall包括后在调查过程中收集的相关信息的摘要变动是根据描述的设备或生产过程的改变（交叉引用的相应部分原器件描述或制造工艺）;，如果设计控制的变化，一个声明，没有新的风险，确定相应的风险分析和核查和验证测试，被用来评估适当情况下，证明设计输出满足设计输入的要求。如果使用另一种方法评估，该通知须包括担任可靠的信息支撑的变化的信息的总结。

(B)For a protocol change,the notice shall include a description of the change (cross-referenced to the appropriate sections of the original protocol);an assessment supporting the conclusion that the change does not have a significant impact on the study design or planned statistical analysis;

and a summary of the information that served as the credible information supporting the sponsor’s determination that the change does not affect the rights,safety, or welfare of the subjects.

（二）协议变更，该通知须包括变化的描述（交叉引用的原始协议的相应部分）;支持结论的变化不具有重大影响的研究设计或评估计划统计分析;担任可靠的信息支持赞助商的决心，这种变化并不影响受试者的权利，安全或福利的信息的总结。

(4)Changes submitted in annual report.The requirements of paragraph(a)(1)of this section do not apply to minor changes to the purpose of the study,risk analysis, monitoring procedures,

labeling,informed consent materials,and IRB information that do not affect:

(i)The validity of the data or information resulting from the completion of the

approved protocol,or the relationship of likely patient risk to benefit relied upon to approve the protocol;

(ii)The scientific soundness of the investigational plan;or

(iii)The rights,safety,or welfare of the human subjects involved in the investigation.

Such changes shall be reported in the annual progress report for the IDE,under§812.150(b)(5).

（4）提交的年度报告。上文（a）（1）本节的要求并不适用于研究的目的，风险分析，监控程序的细微变化，标签，知情同意的材料，和IRB的信息，不影响：

（i）本有效性的数据或信息，从而完成从批准的协议，或病人可能的风险，受益赖以批准该协议的关系;

（ii）本科学性的研究计划;

（iii）在调查涉及人类受试者的权利，安全或福利。这样的变化，应报告为IDE的年度进展报告，根据§812.150（b）条（5）。

(b)IRB approval for new facilities.A sponsor shall submit to FDA a certification of any IRB approval of an investigation or a part of an investigation not included in the IDE application.If the investigation is otherwise unchanged,the supplemental application

shall consist of an updating of the information required by§812.20(b)and(c) and a description of any modifications in the investigational plan required by the IRB as a condition of approval.A

certification of IRB approval need not be included in the initial submission of the supplemental application,and such certification is not a precondition for agency consideration of the application.Nevertheless,a sponsor may not begin a part of an investigation at a facility until the IRB has approved the investigation,FDA has received the certification of IRB approval,and FDA,

under§812.30(a),has approved the supplemental application relating to that part of the investigation(see§56.103(a)).

(B)IRB的批准，新的设施。申请商应当提交FDA认证

IRB批准的任何调查或调查不包括在IDE中的申请程序的一部分。如果调查否则不变，补充申请应包括更新所需的信息§812.20（b）和（c）和研究计划的任何修改，需要由IRB批准的条件的描述。一IRB的批准认证不需要被包括在最初提交的补充申请，这样的认证是不是考虑该申请机构的先决条件。不过，赞助商可能不会开始的一家工厂进行调查的一部分，直到IRB批准的调查，FDA已收到IRB的批准认证，FDA，根据§812.30（a）条，已批准有关的补充申请，调查的一部分（见§56.103（一））。

§812.36Treatment use of an investigational

Device.

(a)General.A device that is not approved for marketing may be under clinical investigation for a serious or immediately life-threatening disease or condition in patients for whom no comparable

or satisfactory alternative device or other therapy is available.

During the clinical trial or prior to final action on the marketing application, it may be appropriate to use the device in

the treatment of patients not in the trial under the provisions of a treatment investigational device exemption(IDE).The purpose of this section is to facilitate the availability of promising

new devices to desperately ill patients as early in the device development process as possible,before general marketing begins,and to obtain additional data on the device’s safety and effectiveness.In the case of a serious disease,a device ordinarily may be made

available for treatment use under this section after all clinical trials have been completed.In the case of an immediately life-threatening disease,a device may be made available for treatment

use under this section prior to the completion of all clinical trials.For the purpose of this section,an‘‘immediately life-threatening’’disease means a stage of a disease in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.For purposes of this section,‘‘treatment use’’of a device includes the use of a device for diagnostic purposes.

（a）一般。不批准上市的一种设备，可以根据临床调查严重或立即危及生命的疾病或状况的患者对他们来说没有任何可比性还是令人满意的替代设备，或其他治疗。在临床试验或营销申请的最终行动之前，可适当使用该设备治疗的患者在试验治疗研究设备豁免（IDE）的规定下。本节的目的是为了方便有前途的可用性新设备在设备开发过程中尽可能早病重患者，一般的营销开始之前，并获得额外的设备的安全性和有效性的数据。在一种严重的疾病的情况下，一个设备可以由通常根据本条处理使用后，所有的临床试验已完成。立即威胁生命的疾病的情况下，一个设备可能会提供治疗根据本条前完成所有临床试验。本节的目的，“立即危及生命的”病是指一种疾病，其中有一个合理的可能性，死亡将发生在几个月的事或过早死亡很可能没有早期治疗的一个阶段。对于本节的目的，治疗使用“一个设备包括用于诊断目的的装置的使用。

(b)Criteria.FDA shall consider the use of an investigational device under a treatment IDE if:

(1)The device is intended to treat or diagnose a serious or immediately lifethreatening

disease or condition;

民事判决书翻译常用词汇归纳

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Cainozoic 新生界 Quaternary 第四系Quaternary period 第四纪Paleocene 第三纪古新世、古近系 Mesozoic中生界 Cretaceous 白垩系 Jurassic 侏罗系 Triassic 三叠系 LateTriassicepoch 晚三叠世 Paleozoic 古生界 Permian 二叠系 LatePermianepoch Early Permian 早二叠世 Carboniferous 石炭系石炭纪 Late Carboniferous Devonian 泥盆系泥盆纪upperDevonionseries 上泥盆统 siluric 志留系Silurian 志留纪 Ordovician 奥陶系奥陶纪 Cambrian 寒武系寒武纪 Proterozoic era 元古代

那些临床试验需要注册

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nail 指甲 nail-biting 束手无策 nail-clippers 指甲刀nailbrush 指甲刷 nailer 敲打工人 nailery 制钉工厂nailhead 钉头 nailhole 钉眼 nailing 敲钉的 nailless 没有指甲的naillike 像指甲的 nailsick 不结实的nainsook 薄棉织物 naira 奈拉 Nairobi 奈洛比naissance 诞生 naive 天真的 naively 天真烂漫地naivete 纯真 naivety 天真烂漫 naked call 无担保承购期权naked eye 肉眼 naked 裸体的 nakedize 成为裸体nakedly 赤裸裸nakedness 裸 naker 定音鼓 Nakhodka 不冻港 naled 二溴磷 namable 可定名的namaste 合十礼namaycush 湖红点鲑namby-pamby 感伤的name after 按...命名name brand 名牌 name it 讲出来 name plate 名牌 name sb for 把...命名为name 名字 name-calling 骂人 name-child 起名 name-drop 抬高身价name-dropping 提高身份nameable 可命名的

临床试验方案模板word版本

临床试验方案模板

临床批件号：XXXXXXXX XXXXXX用于镇痛的Ⅱ期临床试验方案 临床研究组长单位：XXXXXXXXXXXXXXX 临床研究负责人：XXXX 临床研究参加单位： XXXXXXXXXXXXXX XXXXXXXXXXXXXX XXXXXXXXXXXXXX 申报单位：XXXXXXXXXX 试验负责人：XXXX

1．研究题目 XXXX与XXXX对照治疗术后疼痛和癌性疼痛疗效和安全性的多中心、随机双盲、平行对照临床试验 2．研究背景 XXXX为全合成强效镇痛药，化学名为XXXXXXXXXXXXX。其结构和药理活性与XXX相似。由XXX公司研制，于1957年上市(商品名：XXXX)。国外临床前研究认为，XX与XX同属于XX受体激动剂。其镇痛强度约为XX的4倍，XXXX12-50倍，用药后15-30分钟起效，1小时血药浓度达峰值。半衰期比XX长，因而作用时间也较长，长期用药后，体内有一定的蓄积作用。其毒副作用与XX相似，依赖性潜力与XX相当。可能的不良反应有：XXXXXXXXXXXXXXXXX等，这些反应发生率均较低，且随用药时间延长会逐渐减轻和消失，或于停药后消失。 本品由XXXXXXXXXX研制，现经国家食品药品监督管理局批准XXXXX)进行II期临床试验研究，由XXXXXXXXXXXX(国家药品临床研究基地)为临床研究负责单位，XXXXXXXX、XXXXXXXX和XXXXXXXXX 为参加单位。 3．研究目的 考察XXXXXXXXX临床镇痛的有效性和安全性。 4．申报单位和研究单位 申报单位：XXXXXXXXXXXX 地址：XXXXXXXXXXXX 试验负责人：XXX：xxxxxxxxxxx E-mail: xxxxxxxxxxxxx

大数据时代英文翻译

Era of Big Data is a woman's age; women in the gene can accumulate and deal with big data/ women are born to accumulate and deal with big data. Many men and children, in fact, have been wondering about this special ability of women. Like, as a child, just as soon as you entered the house your Mother said immediately in a suspicious tone: “Liu zhijun, you didn’t do well in the exam today, did you.” Another example, you just have a glance at the mobile phone, your wife laughs: “Does Er gou the next door ask you to play games?” One more ex ample, when you close the door and make a phone call, your girlfriend will cry: “Who are shot in bed?” They are sometimes right, sometimes wrong. However, On the whole, the accuracy rate is higher than chance level. When they are wrong, men would sneer women always give way to foolish fancies; when they are right, men would say women are sensitive animal maybe with more acute sensory organs. Anyway, that is a guess. It has already scared man that overall accuracy rate is higher than the random level. In order to adapt to this point, the male also developed a very strong skills against reconnaissance. This part is beyond the scope of this article, so no more details about it. Some studies, such as Hanna Holmes’s paper, have indi cated that the white matter of the female’s brain is higher than that of the male. So they have very strong imagination of connecting things together. Some recent studies have shown that women are better than men in the "date" memory. That is the reason why they are able to remember all the birthdays, anniversaries, and even some of the great day of unimportant friends. No matter whether these results are true or not, I am afraid that this is not women's most outstanding ability. Women's most remarkable ability is a long-term tracking of some seemingly unimportant data to form their own baseline and pattern. Once the patterns of these data points are significantly different from the baseline she is familiar with, she knows something unusual. In their daily life, women do not consider the difference between causality and correlation. They believe in the principle: "There must be something wrong out of something unusual." People who talk about big data often take Lin Biao as an example. Lin Biao recorded some detailed and unimportant data after a battle. Such as seized guns, the proportion of rifles and pistols, the age levels of war prisoners, seized grain, whether they are sorghum or millet, etc., all of which were unavoidably recorded in the book. Others laughed at him. But later, he determined where the enemy headquarters were according to these data. What women do is almost the same. A girl A has a secret crush on boy B, but she usually doesn’t contact him directly. Two days later, I asked her if she wanted to ask him to have dinner together. She said he was playing. I wondered “how do you know that?” She said that boy B usually is on the line Gmail at 8:00 am, away status at8:30am, for he goes out to buy coffee and breakfast, on line again at 9:00am, busy status, for he is at work, away again at12:30am for lunch, on line for whole evenings, maybe for reading or playing games. His buddy C is on line at10:00 am, still online till 2:00am next day. He is a boy who gets up late and stays up late. His buddy D is on line for the most of the day. However, the most important pattern is that there are 2-3 days per week, during which they would be offline or away for 3-4 hours together. Conclusion: they are playing together.