MDR-EU-2017-745-欧盟医疗器械法规 -附录 15

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本文转载自“木之唐咨询”

ANNEX XV 临床研究 CLINICAL INVESTIGATIONS

第 I 章

1.       一般要求GENERAL REQUIREMENTS伦理学原则Ethical principles临床研究中的每一步，从首先考虑研究的必要性和正当性到公布结果，均应符合公认的伦理原则。Each step in the clinical investigation, from the initialconsideration of the need for and justification of the study to the publicationof the results, shall be carried out in accordance with recognised ethicalprinciples.

2.       方法 Methods

2.1   临床研究应在反映最新的科学和技术知识的适当研究方案的基础上进行，并进行定义以证实或驳斥第62(1)条中所所述器械相关的安全性、性能和有关风险-收益要求的制造商声明；这些临床研究应有足够的观察数量，来保证结论的科学有效性。设计和选择的统计方法的基本原理应按照本附录第II章第3.6节中的进一步说明进行说明。Clinicalinvestigations shall be performed on the basis of an appropriate plan ofinvestigation reflecting the latest scientific and technical knowledge anddefined in such a way as to confirm or refute the manufacturer's claimsregarding the safety, performance and aspects relating to benefit-risk ofdevices as referred to in Article 62(1); the clinical investigations shallinclude an adequate number of observations to guarantee the scientific validityof the conclusions. The rationale for the design and chosen statisticalmethodology shall be presented as further described in Section 3.6 ofChapter II of this Annex.

2.2   执行临床研究所用的流程应适合所研究的器械。The procedures used to perform theclinical investigation shall be appropriate to the device under investigation.

2.3   执行研究所用的研究方法应适合所研究的器械。The research methodologies used toperform the clinical investigation shall be appropriate to the device underinvestigation.

2.4   临床研究应由足够数量的预期使用者按照临床研究计划在可代表目标患者人群使用器械的预期正常条件的临床环境中执行。这些临床研究应与附录XIV第A部分中所述的临床评价计划一致。Clinicalinvestigations shall be performed in accordance with the clinical investigationplan by a sufficient number of intended users and in a clinical environmentthat is representative of the intended normal conditions of use of the devicein the target patient population. Clinical investigations shall be in line withthe clinical evaluation plan as referred to in Part A of Annex XIV.

2.5   器械的一切合适的技术和功能特征（特别是涉及安全性和性能方面的特征）以及其预期的临床结果的影响应由研究设计进行适当解决和检验。应提供一份列表，列明器械的技术和功能特征和相关预期的临床结果。All the appropriate technical and functional features of the device,in particular those involving safety and performance, and their expectedclinical outcomes shall be appropriately addressed in the investigationaldesign. A list of the technical and functional features of the device and therelated expected clinical outcomes shall be provided.

2.6   临床研究的终点应确定器械的预期用途、临床益处、性能和安全性。终点必须使用科学有效的方法来进行确定和评估。主要终点应与器械和临床相关性匹配。The endpoints of the clinical investigation shall address theintended purpose, clinical benefits, performance and safety of the device. Theendpoints shall be determined and assessed using scientifically validmethodologies. The primary endpoint shall be appropriate to the device andclinically relevant.

2.7   研究者应有权使用器械相关的技术和临床数据。参与研究的人员应接受关于正确使用试验用器械、临床研究计划和《医疗器械临床试验质量管理规范》方面的指导和培训。此等培训应予以核实，并（在必要时）由申办方安排并正确记录。Investigators shall have access to the technical and clinical dataregarding the device. Personnel involvedin the conduct of an investigationshall be adequately instructed and trained in the proper use of theinvestigational device, and as regards the clinical investigation plan and goodclinical practice. This training shall be verified and where necessary arrangedby the sponsor and documented appropriately.

2.8   由研究者签字的临床研究报告，应包括对临床研究过程中收集到的所有数据的严格评价，且应包括所有反向发现。Theclinical investigation report, signed by the investigator, shall contain acritical evaluation of all the data collected during the clinicalinvestigation, and shall include any negative findings.

第II章 临床研究申请表的有关文件DOCUMENTATION REGARDING THE APPLICATION FORCLINICAL INVESTIGATION

对于第62条中涵盖的试验用器械，申办方应当根据第70条之要求拟定申请表并与下列文件一起递交申请表：For investigational devices covered by Article 62, the sponsorshall draw up and submit the application in accordance with Article 70accompanied by the following documents:

1.     申请表Application form申请表应填写完整，包含以下信息：The application form shall be duly filled in, containing informationregarding:

1.1   申办方的名称、地址和联系方式，和联系人/根据第62(2)条指定的其欧盟法定代理人的姓名、地址和联系方式（如适用）；name, address and contact details of the sponsor and, if applicable,name, address and contact details of its contact person or legal representativein accordance with Article 62(2) established in the Union;

1.2   临床研究器械的制造商和其授权代表（如适用）的名称、地址和联系方式（若第1.1节不适用）；if different from those in Section 1.1, name, address andcontact details of the manufacturer of the device intended for clinicalinvestigation and, if applicable,of its authorised representative;

1.3   临床研究的题目；title of the clinical investigation;

1.4   临床研究申请表的状态（即第一次提交、再次提交和重大修改）；status of the clinicalinvestigation application (i.e. first submission, resubmission,significantamendment);

1.5   临床评价计划的详情/说明；Details and/orreference to the clinical evaluation plan;

1.6   关于同一器械，若重新提交之前已提交过的申请，则先前提交的先前日期和参考编号，或在重大修改的情况下，应参考原始申请。申办方应确定上次申请的所有变更以及该等变更的理由，特别是是否对以前的主管机构或伦理委员会审查结果进行了任何更改；If the application is a resubmission with regard to a device forwhich anapplication has been already submitted, the date or dates and referencenumber or numbers of the earlier application or in the case of significantamendment, reference to the original application. The sponsor shall identifyall of the changes from the previous application together with a rationale forthose changes, in particular, whether any changes have been made to addressconclusions of previous competent authority or ethics committee reviews;

1.7   若申请与根据第536/2014号法规的临床试验申请并行提交，请参考临床试验的正式注册号；if the application is submitted in parallel with an application fora clinical trial in accordance with Regulation (EU) No 536/2014,referenceto the official registration number of the clinical trial;

1.8   申请表时作为多中心或多国研究的一部分而进行的临床研究所在成员国和第三国的标识信息；identificationof the Member States and third countries in which the clinicalinvestigation is to be conducted as part of a multicentre or multinationalstudy at the time of application;

1.9   试验用器械的简要说明、分类和标识器械和器械类型所必要的其他信息；a brief description ofthe investigational device, its classification and other information necessaryfor the identification of the device and device type;

1.10  器械是否使用药用物质，包括人体血液或血浆的衍生物，或者是否在生产时采用非活性人体或动物组织或细胞或其衍生物的相关信息；informationas to whether the device incorporates a medicinalsubstance, including a human blood or plasma derivative or whether it ismanufactured utilising non-viabletissues or cells of human or animal origin, ortheir derivatives;

1.11     临床研究计划的总结，包括临床研究的对象、受试者的数量和性别、受试者选择标准、未满18周岁的受试者、研究的设计（如对照研究和/或随机研究）以及开始和完成临床研究的计划日期）；summary of theclinical investigation plan including the objective or objectives of theclinical investigation, the number and gender of subjects, criteria for subjectselection, whether there are subjects under 18 years of age, design of theinvestigation such as controlled and/or randomised studies, planned dates ofcommencement and of completion of the clinical investigation;

1.12    若适用，关于比对器械的信息，用于标识比对器械所必需的分类信息和其他信息；if applicable,information regarding a comparator device, its classification and otherinformation necessary for the identification of the comparator device;

1.13     申办方提供的证据，证明临床研究者和试验场所具备按照临床研究计划进行临床研究的能力；evidence fromthe sponsor that the clinical investigator and the investigational site arecapable of conducting the clinical investigation in accordance with theclinical investigation plan;

1.14    研究的预期开始日期和持续时间的详细信息；details of the anticipatedstart dateand duration of the investigation;

1.15  用于确定公告机构的详细信息，若在临床研究申请阶段已涉及；details to identify thenotified body, if already involved at the stage of application for a clinicalinvestigation;

1.16  确认申办方知悉主管机构可与评估或已评估申请表的伦理委员会联系。confirmation that thesponsor is aware that the competent authority may contact the ethics committeethat is assessing or has assessed the application; and

1.17    第4.1节所述的声明。the statement referredto in Section 4.1.2.    研究者手册Investigator's Brochure研究者手册（IB）应包含与研究相关并在申请表时提供的试验用器械的临床和非临床信息。对新出版的IB或其他相关信息的任何更新，应及时提请研究者注意。应明确标识IB，并特别包含以下信息：The investigator's brochure(IB) shall contain the clinical and non-clinical informationon theinvestigational device that is relevant for the investigation and available atthe time of application. Any updates to the IB or other relevant informationthat is newly available shall be brought to the attention of theinvestigatorsin a timely manner. The IB shall be clearly identified and containin particular the following information:

2.1   器械的标识和说明，包括关于预期目的信息、根据附录VIII的风险分类和适用的分类规则、器械的设计和生产以及对前一代器械和类似器械的引用。Identification and description of the device, including informationon the intended purpose, therisk classification and applicable classificationrule pursuant to Annex VIII, design and manufacturing of the device and referenceto previous and similar generations of the device.

2.2   制造商的安装、维护、维护卫生标准和使用说明（包括储存和处理要求），以及在提供此信息时，要贴在标签上的信息，以及在市售上时用于与器械一起提供的说明。此外，需要任何有关相关培训的信息。Manufacturer's instructions for installation, maintenance,maintaining hygiene standards andfor use, including storage and handlingrequirements, as well as, to the extentthat such information is available,information to be placed on the label, andinstructions for use to be providedwith the device when placed on the market.In addition, information relating toany relevant training required.

2.3   临床前评估基于相关的临床前试验和实验数据，特别是设计计算、体外试验、半体内试验、动物试验、机械或电气试验、可靠性试验、灭菌验证、软件验证和确认、性能测试以及对生物相容性和生物安全性的评估（如适用）。Pre-clinical evaluation based on relevant pre-clinical testing andexperimental data, inparticular regarding in-design calculations, in vitrotests, ex vivo tests, animaltests, mechanical or electrical tests, reliabilitytests, sterilisation validation, software verification and validation,performance tests, evaluation of biocompatibility and biological safety, asapplicable.

2.4   现有临床数据，特别是：Existing clinical data, in particular:器械和/或等同或类似器械的安全性、性能、患者的临床益处、设计特性和预期用途相关的现有相关科学文献；from relevant scientific literature available relating to thesafety, performance, clinical benefits to patients, design characteristics andintended purpose of the deviceand/or of equivalent or similar devices;同一制造商的等同或类似器械的安全性、性能、患者的临床益处、设计特性和预期用途相关的其他现有临床数据，包括上市时长与性能评价、临床效果与安全性相关问题以及采取的纠正措施；other relevant clinical data available relating to the safety,performance, clinical benefits to patients, design characteristics and intendedpurpose of equivalentor similar devices of the same manufacturer, includinglength of time on the marketand a review of performance, clinical benefit andsafety-related issues and any corrective actions taken.

2.5   风险利益分析与风险管理的总结，包括已知或可预见的风险相关的信息、任何不良反应、禁忌症和警告。Summary ofthe benefit-risk analysis and the risk management, including informationregarding known or foreseeable risks, any undesirable effects,contraindications and warnings.

2.6   对于药械组合的器械，包括人体血液或血浆的衍生物，或生产时利用非活性人体或动物组织或细胞或其衍生物，该药物或者组织或细胞或其衍生物的详细信息，或对通用安全与性能要求或药物、组织或细胞或其衍生物相关的特定风险管理的遵从性的详细信息，以及掺入这些成分对关于器械的临床效果和/或安全性的附加价值的证据。In the case of devices thatincorporate a medicinal substance, including a human blood or plasma derivativeor devices manufactured utilising non-viable tissues or cells of human oranimal origin, or their derivatives, detailed information on the medicinalsubstance or on the tissues, cells or their derivatives, and on the compliancewith the relevant general safety and performance requirements and the specificrisk management in relation to the substance or tissues, cellsor theirderivatives, as well as evidence for the added value of incorporationof suchconstituents in relation to the clinical benefit and/or safety of the device.

2.7   详细说明附录I所列相关一般安全性和性能要求的列表，包括全部或部分适用的标准和CS，以及符合（或不符合/仅部分符合这些标准和CS/缺乏）相关一般安全性和性能要求的解决方案说明。A list detailingthe fulfilment of the relevant general safety and performance requirements setout in Annex I, including the standards and CS applied, in full or inpart,as well as a description of the solutions for fulfilling the relevant generalsafety and performance requirements, in so far as those standards and CS havenot or have only been partly fulfilled or are lacking.

2.8   对临床研究过程中使用的临床流程和诊断测试的详细说明，以及（特别是）正常临床实践的任何相关偏差信息。A detaileddescription of the clinical procedures and diagnostic tests used inthe courseof the clinical investigation and in particular information on any deviationfrom normal clinical practice.

3.     临床研究计划Clinical Investigation Plan临床研究计划（CIP）应规定临床研究的理论基础、目标、设计和拟定分析、方法论、监控、执行、记录保存以及临床研究分析方法。其应特别包含本附录所述的信息。若这部分资料以一份单独文件的方式提交，应在CIP中说明。The clinical investigation plan (CIP)shall set out the rationale, objectives, design methodology, monitoring,conduct, record-keeping and the method of analysis for the clinicalinvestigation. It shall contain in particular the information as laiddown inthis Annex. If part of this information is submitted in a separate document,itshall be referenced in the CIP.

3.1   总则General

3.1.1       第70(1)条所述的临床研究的唯一标识号。 Singleidentification number of the clinical investigation, as referred to inArticle 70(1).

3.1.2       根据第62(2)条，提供来自欧盟的申办方的标识信息——申办方联系人的名称、地址和联系方式，或指定的其法定代理人的姓名、地址和联系方式（如适用）。Identification of the sponsor — name, address and contact details ofthe sponsor and, where applicable,the name, address and contact details of thesponsor's contact person or legal representative in accordance withArticle 62(2) established in the Union.

3.1.3       各试验机构的主要研究者以及协调研究者的信息、各试验机构的地址信息以及各机构主要研究者的紧急联系方式。各类研究者的任务、职责和资质应在CIP中做出规定。 Information on the principalinvestigator at each investigational site, the coordinating investigator forthe investigation, the address details for each investigational site and theemergency contact details for the principal investigator at each site. Theroles, responsibilities and qualifications of the various kinds ofinvestigators shall be specified in the CIP.

3.1.4       对临床研究费用的简要说明和对申办方与机构之间所达成协议的简要说明。A brief description ofhow the clinical investigation is financed and a brief descriptionof theagreement between the sponsor and the site.

3.1.5       采用成员国确定的欧盟官方语言编写的临床研究概要；Over all synopsis of the clinicalinvestigation,in an official Union language determined by the Member Stateconcerned.

3.2     器械的标识和说明（包括其预期用途、其制造商、其溯源性、其预期使用者、接触人体的材料、在其使用过程中涉及的医疗或外科手术、以及必要的使用培训和使用体验）、新器械的背景文献综述、应用领域中临床医学的现有技术发展水平和拟议效果。Identification and description of the device, including its intendedpurpose, its manufacturer,its traceability, the target population, materialscoming into contact with the human body, the medical or surgical proceduresinvolved in its use and the necessary training and experience for its use,background literature review, the current state of the art in clinical care inthe relevant field of application and the proposed benefits of the new device.

3.3    待检验器械的风险和临床益处，包括在临床研究计划中相应预期临床结果的适当证明。 Risks andclinical benefits of the device to be examined, with justification of thecorresponding expected clinical outcomes in the clinical investigation plan.

3.4     在临床实践的现有技术发展水平下对临床研究相关性的说明。Description of the relevanceof the clinical investigation in the context of the state of the art ofclinical practice.

3.5     临床研究的目标和假设。Objectives and hypotheses of the clinicalinvestigation.

3.6     临床研究的设计，包括对其科学的可靠性和有效性的适当证明。Design of the clinicalinvestigation with evidence of its scientific robustness and validity.

3.6.1       基本信息，如研究的类型，并需说明临床评价计划中规定的各项选择、指标、变量的选用理由。Generalinformation such as type of investigation with rationale for choosing it,forits endpoints and for its variables as set out in the clinical evaluationplan.

3.6.2       临床研究中使用的试验用器械、任何比对器械和任何其他器械或药物的相关信息。 Information onthe investigational device, on any comparator and on any other device ormedication to be used in the clinical investigation.

3.6.3       受试者相关的信息、选择标准、研究人群的规模、关于目标人群的研究人群代表，以及（如适用）所涉及弱势受试者相关的信息，例如孕妇、儿童、免疫力低下者、老年人等）。Information on subjects, selection criteria, size of investigationpopulation, representativeness of investigation population in relation totarget population and, if applicable,information on vulnerable subjectsinvolved such as children, pregnant women, immuno-compromisedor, elderlysubjects.

3.6.4       尽量减少偏差（例如随机化）需采取的措施和对潜在混杂因素的管理的详细信息。Details of measuresto be taken to minimise bias, such as randomisation, and managementof potentialconfounding factors.

3.6.5       对临床研究相关临床流程和诊断方法的说明，并特别突出与正常临床实践的任何偏差。 Descriptionof the clinical procedures and diagnostic methods relating to the clinicalinvestigation and in particular highlighting any deviation from normal clinicalpractice.

3.6.6       监测计划。 Monitoring plan.

3.7    统计方面的考虑，并说明其理由，包括样本量的检验效能（power）计算（如适用）。 Statistical considerations, with justification, including apower calculation for the sample size, if applicable.

3.8     数据管理。Data management.

3.9     对CIP的任何修改信息。 Informationaboutany amendments to the CIP.

3.10  在试验机构跟踪和管理与CIP的任何偏差以及明确禁止CIP豁免相关的政策。Policy regarding follow-up and management of any deviations from theCIP at the investigational site and clear prohibition of use of waivers fromthe CIP.

3.11  对器械的责任，特别是控制对器械的使用，对临床研究中使用器械的追踪以及退还未使用、注册到期或有故障的器械。Accountabilityregarding the device, in particular control of access to the device, follow-upin relation to the device used in the clinical investigation and the return ofunused, expired or malfunctioning devices.

3.12 遵守涉及人类的医学研究公认伦理原则、《医疗器械临床试验质量管理规范》以及适用的法规要求的声明。 Statementof compliance with the recognised ethical principles for medical researchinvolving humans, and the principles of good clinical practice in the field ofclinical investigations of devices, as well as with the applicable regulatoryrequirements.

3.13  对知情同意过程的说明。Description of the Informed consent process.

3.14  安全性报告，包括对不良事件和严重不良事件的定义、报告的器械缺陷、流程和时间表。Safety reporting,including definitions of adverse events and serious adverse events, devicedeficiencies, procedures and timelines for reporting.

3.15  结束、暂时中断或提前终止研究之后对受试者进行跟踪、对撤回知情同意书的受试者进行跟踪，以及对失联受试者进行跟踪的准则和流程。对于植入性器械，此类流程必须包含可追溯性。Criteria and procedures for follow-up of subjects following the end,temporary halt orearly termination of an investigation, for follow-up ofsubjects who have with drawn their consent and procedures for subjects lost tofollow-up. Such procedures shall for implantable devices, cover as aminimum traceability.

3.16  对临床研究结束后受试者照护安排的说明（当由于受试者对临床研究的参与使得额外照护很有必要时，或当情况偏离对所述医疗条件的正常预期时）。A description of the arrangements for taking care of the subjectsafter their participation in the clinical investigation has ended, where suchadditional care is necessary because of the subjects' participation in theclinical investigation and where it differs from that normally expected for themedical condition in question.

3.17  按照第I章第1节中所述的法律要求和伦理原则制定临床研究报告和公布结果方面的政策Policy as regards the establishment of the clinical investigationreport and publication of results in accordance with the legal requirements andthe ethical principles referred to in Section 1 of Chapter I.

3.18  器械的技术和功能特征列表，列明研究所涵盖的技术和功能特征。List of the technical andfunctional features of the device, with specific mention of those covered bythe investigation.

3.19  参考书目。Bibliography.4.     其他信息 Other information

4.1   负责生产试验用器械的自然人或法人签字的声明，声明除了临床研究所涵盖的方面外，所述器械的其他方面均符合通用安全与性能要求，并声明对于临床研究所涵盖的方面，也已采取一切预防措施来保护受试者的健康和安全。A signed statement by the natural or legal person responsible forthe manufactureof the investigational device that the device in questionconforms to the general safety and performance requirements apart from theaspects covered by the clinical investigation and that, with regard to thoseaspects, every precautionhas been taken to protect the health and safety of thesubject.

4.2   根据国家法律规定（如适用）提交的一份相关伦理委员会的意见副本。如根据国家法律规定，不需要在提交申请表时提交伦理委员会的意见时，应在获得后尽快提交一份伦理委员会的意见副本。Where applicable according to national law, copy of the opinion oropinions of the ethics committee or committees concerned. Where according tonational law the opinionor opinions of the ethics committee or committees isnot required at the time ofthe submission of the application, a copy of theopinion or opinions shall besubmitted as soon as available.

4.3   在受试者受到人身伤害的情况下，根据第69条和相应的国家法律规定提交的投保或赔偿证明。Proof of insurance cover or indemnification of subjects in case ofinjury, pursuantto Article 69 and the corresponding national law.

4.4   用于获得知情同意书的文件，包括患者信息表和知情同意文件。Documents to be used toobtain informed consent, including the patient information sheet and theinformed consent document.

4.5   说明遵守关于个人资料保护和保密适用规则的安排，特别是：Description of thearrangements to comply with the applicable rules on the protection andconfidentiality of personal data, in particular:将实施的组织和技术安排，以避免未经授权地访问、披露、传播、变更或丢失已处理的信息和个人数据；organisational and technical arrangements that will be implementedto avoid unauthorised access, disclosure, dissemination, alteration or loss ofinformation and personal data processed;为确保受试者的记录和个人资料保密而将被实施的各项措施的说明；a description of measures that will be implemented to ensureconfidentiality of records and personal data of subjects; and说明在数据安全漏洞的情况下将采取的措施，以减少可能的不利影响。adescription of measures that will be implemented in case of a datasecurity breach in order to mitigate the possible adverse effects.

4.6   技术文件的全部细节（例如详细的风险分析/管理文件或特定测试报告）应按要求提交给主管机构，以便其审查申请表。Full details of the available technical documentation, for exampledetailed risk analysis/management documentation or specific test reports,shall, upon request,be submitted to the competent authority reviewing anapplication.

第III章申办方的其他义务OTHER OBLIGATIONS OF THE SPONSOR

1.     申办方应承诺继续向国家主管机构提供必需的任何文件，以便为本附录第II章中所述的文件提供证据。若申办方并非负责生产试验用器械的自然人或法人，则这一义务也可由申办方的法定代理人履行。The sponsor shall undertake to keep available for the competentnational authoritiesany documentation necessary to provide evidence for thedocumentation referred to in Chapter II of this Annex. If the sponsor isnot the natural or legal person responsible for the manufacture of theinvestigational device, that obligationmay be fulfilled by that person onbehalf of the sponsor.

2.     申办方应达成一份协议，用来确保研究者及时向申办方报告第80(2)条中所述的严重不良事件或任何其他事件。The Sponsor shall have an agreement in place to ensure that anyserious adverse events or any other event as referred to in Article 80(2)are reported by the investigator or investigators to the sponsor in a timelymanner.

3.     本附录中所述的文件应在所述器械的临床研究结束后保存至少10年，或者若器械随后上市，则应在最后一个器械上市至少10年内（植入式器械为至少15年内）妥善保存。The documentation mentioned in this Annex shall be kept for aperiod of at least 10 years after the clinical investigation with the device inquestion hasended, or, in the event that the device is subsequently placed onthe market, atleast 10 years after the last device has been placed on themarket. In the caseof implantable devices, the period shall be at least 15years.

各成员国应要求，本文件应保存第一子段所述明的期限以供主管机构处置，以防申办方或其联系人或根据第62(2)条指定的在其境内的法定代理人在此期限结束之前破产或停止其商业活动。EachMember State shall require that this documentation is kept at the disposalof the competent authorities for the period referred to in the firstsubparagraph incase the sponsor, or its contact person or legalrepresentative as referred toin Article 62(2) established within itsterritory, goes bankrupt or ceasesits activity prior to the end of this period.

4.     申办方应任命一名独立于试验机构的监查员，以确保研究按照CIP、《医疗器械临床试验质量管理规范》和本法规的原则进行。The Sponsor shall appoint a monitor that is independent from theinvestigational site to ensure that the investigation is conducted inaccordance with the CIP, the principlesof good clinical practice and thisRegulation.

5.    申办方应完成对研究受试者的跟踪。 The Sponsor shall complete thefollow-up of investigation subjects.

6.     申办方应提供证据，以确保研究按照《医疗器械临床试验质量管理规范》进行，例如通过内部或外部检查。TheSponsor shall provide evidence that the investigation is being conducted inlinewith good clinical practice, for in stance through internal or externalinspection.

7.     申办方应编写一份临床研究报告，该报告应至少包含以下内容：The Sponsor shall prepare aclinical investigation report which includes at least the following:封面/前言列出研究题目、试验用器械，唯一标识码、CIP数量和详细信息并由各试验场所协调研究者和主要研究者签字。Cover/introductory page or pages indicating the title of theinvestigation, the investigational device, the single identification number,the CIP number and the details with signaturesof the coordinating investigatorsand the principal investigators from each investigational site.

报告的作者和日期等详细信息。Details of the author and date of the report.研究总结应包括题目、研究目的、研究说明、所使用的研究设计和方法、研究结果和研究结论。研究的完成日期，和（特别是）研究的提前终止、中断或暂停的具体信息。A summary of the investigation covering the title, purpose of theinvestigation,description of the investigation, investigational design andmethods used, the results of the investigation and conclusion of theinvestigation. The completion date of the investigation, and in particulardetails of early termination, temporary halts or suspensions of investigations.

试验用器械的说明，特别是明确界定的预期用途。Investigational device description, in particular clearly definedintended purpose.临床研究计划总结应包括目标、设计、伦理方面、监控和质量措施、选择标准、目标患者人群、样本量、治疗方案、跟踪持续时间、伴随治疗、统计计划书，包括假设、样本量计算和分析方法以及正当性证明。A summary of the clinical investigation plan covering objectives,design, ethical aspects, monitoring and quality measures, selection criteria,target patient populations, sample size, treatment schedules, follow-upduration, concomitant treatments, statistical plan, including hypothesis,sample size calculation andanalysis methods, as well as a justification.

临床研究的结果包括，依据和正当性证明、受试者人口统计学、对所选终点结果的分析、亚组分析的详细信息、对CIP的遵从性以及对丢失数据的跟踪和对退出研究/失联患者的跟踪。Results of the clinical investigation covering, with rationale andjustification, subject demographics, analysis of results related to chosenendpoints, details of subgroup analysis, as well as compliance with the CIP,and covering follow-up of missing data and of patients withdrawing from theclinical investigation, or lost to follow-up.

对严重不良事件、不良器械反应和器械缺陷以及任何相关的纠正措施的总结。Summary of serious adverse events, adverse device effects, devicedeficiencies and any relevant corrective actions.讨论和总体结论——安全性和性能结果、风险和临床益处的评估，按照临床技术发展水平对临床相关性的讨论、特定患者人群的任何针对性预防措施，对试验用器械的影响和研究的局限性。Discussion and overall conclusions covering safety and performanceresults, assessment of risks and clinical benefits, discussion of clinicalrelevance in accordance with clinical state of the art, any specificprecautions for specific patient populations, implications for theinvestigational device, limitations of the investigation.