ICH美国临床试验法规选编(汉英对照)
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作者编者:陈东
出版社化学工业
ISBN9787122328847
出版时间2018-11
装帧其他
开本其他
定价80元
货号1201807520
上书时间2024-06-02
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作者简介
陈东，北京米雅康科技有限公司，总经理，湖南医科大学临床医学专业本科毕业，美国CityUniversity工商管理硕士MBA。获得SoCRA(SocietyofClinicalResearchAssociation)的CCRP(CertifiedClinicalResearchProfessional)认证和PMI(ProjectManagementInstitution)的PMP(ProjectManagementProfessional)认证；曾任职于中国医学科学院信息所，湘雅医科大学药理教研组，法玛西亚公司，舒泰神药厂，昭衍药物研究所，PPD公司，从事新药研究十余年，丰富的国内科研机构、药物生产企业和研发公司从业经验；曾任职于渥太华医院进行临床研究，有丰富的国外临床试验经验；在PPD公司担任全球高级培训师六年，针对项目经理PM，临床试验经理CTM，监督者CRA，临床试验助理PM，临床试验协调员CRC，培训过近千名临床试验专业人员；为PPD的全球领导层进行精准六西格玛（LeanSixSigma）培训,指导公司部门经理完成电子临床试验主要文档过程优化（eTMFWorkshop）的精准六西格玛项目；除PPD公司的内部培训外，还为辉瑞Pfizer公司进行监督者GCP工作坊（PfizerCRAWorkshop）的培训，以及位葛兰素公司GSK进行ICHGCP培训，为日本武田公司Takeda编写临床试验的培训教材，并针对南非和泰国的临床研究者进行ICHGCP培训。
目录
国际人用药品注册技术协调会（ICH）
——临床试验质量管理规范指导原则（E6_R2）
引言3
1术语4
2ICH GCP 的原则12
3机构审查委员会/独立伦理委员会（IRB/IEC）14
3.1职责14
3.2组成、职责和运作15
3.3程序15
3.4记录16
4研究者17
4.1研究者的资格和协议17
4.2足够的资源17
4.3受试者的医疗保健18
4.4与IRB/IEC沟通18
4.5依从试验方案18
4.6试验用药19
4.7随机化程序和破盲19
4.8受试者的知情同意20
4.9记录和报告23
4.10进展报告24
4.11安全性报告24
4.12试验的终止或暂停24
4.13研究者的最终报告25
5申办者25
5.0质量管理25
5.1质量保证和质量控制27
5.2合同研究组织（CRO）27
5.3医学专家27
5.4试验设计28
5.5试验管理、数据处理与记录保存28
5.6研究者的选择30
5.7责任的分配30
5.8对受试者和研究者的补偿30
5.9财务31
5.10通知/申报管理当局31
5.11IRB/IEC审评和确认31
5.12有关试验用药信息32
5.13试验用药的生产、包装、标签和编码32
5.14试验用药的供应和管理32
5.15记录查阅33
5.16安全性信息33
5.17药品不良反应报告33
5.18监查34
5.19稽查38
5.20不依从38
5.21提前终止或暂停试验39
5.22临床试验/研究报告39
5.23多中心试验39
6临床试验方案和方案增补40
6.1一般信息40
6.2背景信息40
6.3试验目标和目的41
6.4试验设计41
6.5受试者的选择和退出41
6.6受试者的治疗42
6.7有效性评价42
6.8安全性评价42
6.9统计42
6.10直接查阅原始数据/文件42
6.11质量控制和质量保证43
6.12伦理学43
6.13数据处理与记录保存43
6.14财务和保险43
6.15出版策略43
6.16补充43
7研究者手册43
7.1引言43
7.2总论44
7.3研究者手册的内容44
7.4附录149
7.5附录250
8实施临床试验的核心文件51
8.1引言51
8.2临床试验开始之前52
8.3临床试验进行期间54
8.4临床试验完成或终止之后57
美国联邦法案
21CFR第11部分电子记录/电子签名60
子部分A总则60
11.1适用范围60
11.2履行60
11.3定义61
子部分B电子记录62
11.10封闭系统的控制62
11.30开放系统的控制63
11.50签名显示63
11.70签名/记录链接64
子部分C电子签名64
11.100一般要求64
11.200电子签名构成要素及管控64
11.300识别码/密码的管控65
21CFR第50部分保护人类受试者66
子部分A总则66
50.1范围66
50.3定义66
子部分B人类受试者知情同意70
50.20对知情同意的一般要求70
50.23一般要求之外的例外情形70
50.24为急救研究豁免知情同意的要求75
5ion.357
Sec.312.22General principles of the IND submission.358
Sec.312.23IND content and format.359
Sec.312.30Protocol amendments.369
Sec.312.31Information amendments.371
Sec.312.32IND safety reporting.372
Sec.312.33Annual reports.377
Sec.312.38Withdrawal of an IND.378
Subpart C-Administrative Actions379
Sec.312.40General requirements for use of an investigationalnew drug in a clinical investigation.379
Sec.312.41Comment and advice on an IND.379
Sec.312.42Clinical holds and requests for modification.380
Sec.312.44Termination.384
Sec.312.45Inactive status.387
Sec.312.47Meetings.388
Sec.312.48Dispute resolution.391
Subpart D-Responsibilities of Sponsors and Investigators392
Sec.312.50General responsibilities of sponsors.392
Sec.312.52Transfer of obligations to a contract researchorganization.392
Sec.312.53Selecting investigators and monitors.393
Sec.312.54Emergency research under 50.24 of this chapter.395
Sec.312.55Informing investigators.396
Sec.312.56Review of ongoing investigations.396
Sec.312.57Recordkeeping and record retention.397
Sec.312.58Inspection of sponsor?s records and reports.397
Sec.312.59Disposition of unused supply ofinvestigational drug.398
Sec.312.60General responsibilities of investigators.398
Sec.312.61Control of the investigational drug.399
Sec.312.62Investigator recordkeeping and record retention.399
Sec.312.64Investigator reports.399
Sec.312.66Assurance of IRB review.400
Sec.312.68Inspection of investigator apos;s records and reports.400
Sec.312.69Handling of controlled substances.401
Sec.312.70Disqualification of a clinical investigator.401
Subpart E-Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses403
Sec.312.80Purpose.403
Sec.312.81Scope.403
Sec.312.82Early consultation.404
Sec.312.83Treatment protocols.405
Sec.312.84Risk-benefit analysis in review of marketingapplications for drugs to treat life-threateningand severely-debilitating illnesses.405
Sec.312.85Phase 4 studies.406
Sec.312.86Focused FDA regulatory research.406
Sec.312.87Active monitoring of conduct and evaluationof clinical trials.406
Sec.312.88Safeguards for patient safety.406
Subpart F-Miscellaneous407
Sec.312.110Import and export requirements.407
Sec.312.120Foreign clinical studies not conductedunder an IND.411
Sec.312.130Availability for public disclosure of data and information in an IND.414
Sec.312.140Address for correspondence.415
Sec.312.145Guidance documents.416
Subpart G-Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests416
Sec.312.160Drugs for investigational use in laboratory research animals or in vitro tests.416
Subpart H [Reserved]418
Subpart I-Expanded Access to Investigational Drugs for Treatment Use418
Sec.312.300General.418
Sec.312.305Requirements for all expanded access uses.419
Sec.312.310Individual patients,including for emergency use.422
Sec.312.315Intermediate-size patient populations.424
Sec.312.320Treatment IND or treatment protocol.426
21CFRPART812INVESTIGATIONAL DEVICE EXEMPTIONS428
Subpart A-General Provisions428
812.1Scope.428
812.2Applicability.429
812.3Definitions.431
812.5Labeling of investigational devices.433
812.7Prohibition of promotion and other practices.434
812.10Waivers.435
812.18Import and export requirements.435
812.19Address for IDE correspondence.435
Subpart B-Application and Administrative Action436
812.20Application.436
812.25Investigational plan.438
812.27Report of prior investigations.439
812.30FDA action on applications.439
812.35Supplemental applications.441
812.36Treatment use of an investigational device.444
812.38Confidentiality of data and information.448
Subpart C-Responsibilities of Sponsors449
812.40General responsibilities of sponsors.449
812.42FDA and IRB approval.450
812.43Selecting investigators and monitors.450
812.45Informing investigators.451
812.46Monitoring investigations.451
812.47Emergency research under 50.24 of this chapter.452
Subpart D-IRB Review and Approval452
812.60IRB composition,duties,and functions.452
812.62IRB approval.452
812.64IRB?s continuing review.452
812.65[Reserved]453
812.66Significant risk device determinations.453
Subpart E-Responsibilities of Investigators453
812.100General responsibilities of investigators.453
812.110Specific responsibilities of investigators.453
812.119Disqualification of a clinical investigator.454
Subpart F [Reserved]456
Subpart G-Records and Reports456
812.140Records.456
812.145Inspections.459
812.150Reports.459
45CFRPART46PROTECTION OF HUMAN SUBJECTS463
Subpart A-Basic HHS Policy for Protection of Human Research Subjects463
46.101To what does this policy apply?(Omit)463
46.102Definitions.463
46.103Assuring compliance with this policy—research conducted or supported by any Federal Department or Agency.465
46.104—46.106 [Reserved]467
46.107IRB membership.467
46.108IRB functions and operations.468
46.109IRB review of research.469
46.110Expedited review procedures for certain kinds of research involving no more than minimal risk,and for minor changes in approved research.469
46.111Criteria for IRB approval of research.470
46.112Review by institution.471
46.113Suspension or termination of IRB approval of research.471
46.114Cooperative research.472
46.115IRB records.472
46.116General requirements for informed consent.473
46.117Documentation of informed consent.475
46.118Applications and proposals lacking definite plans for involvement of human subjects.476
46.119Research undertaken without the intention of involving human subjects.477
46.120Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency.477
46.121[Reserved]477
46.122Use of Federal funds.477
46.123Early termination of research support: Evaluation of applications and proposals.477
46.124Conditions.478
Subpart B-Additional Protections for Pregnant Women,Human Fetuses and Neonates Involved in Research478
46.201To what do these regulations apply? (Omit)478
46.202Definitions.478
46.203Duties of IRBs in connection with research involving pregnant women,fetuses,and neonates.479
46.204Research involving pregnant women or fetuses.479
46.205Research involving neonates.480
46.206Research involving,after delivery,the placenta,the dead fetus or fetal material.482
46.207Research not otherwise approvable which presents an opportunity to erstand,prevent,or alleviate a serious problem affecting the health or welfare ofpregnant en,fetuses,orneonates.482
Subpart C-Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects483
46.301Applicability(Omit). 483
46.302Purpose.483
46.303Definitions.483
46.304Composition of Institutional Review Boards where prisoners are involved.484
46.305Additional duties of the Institutional Review Boardswhere prisoners are involved.484
46.306Permitted research involving prisoners.485
Subpart D-Additional Protections for Children Involved as Subjects in Research486
46.401To what do these regulations apply?(Omit)486
46.402Definitions.486
46.403IRB duties.487
46.404Research not involving greater than
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