ICH/美国临床试验法规选编

本书以中英文对照的形式对ICH GCP（E6_R2）以及美国联邦法规21CFR和45CFR有关临床试验相关章节进行翻译、汇编，中英文对照方便读者学习、查阅。本书适用于制药企业、新药研发机构、临床试验机构、CRO公司、SMO公司的从业人员，也可供相关管理部门参考。 

本书以中英文对照的形式对ICH GCP（E6_R2）以及美国联邦法规21CFR和45CFR有关临床试验相关章节进行翻译、汇编，中英文对照方便读者学习、查阅。本书适用于制药企业、新药研发机构、临床试验机构、CRO公司、SMO公司的从业人员，也可供相关管理部门参考。

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City University 工商管理硕士MBA。获得SoCRA(Society of Clinical Research Association)的CCRP(Certified Clinical Research Professional)认证和PMI(Project Management Institution) 的PMP(Project Management Professional)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（Lean Six Sigma）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（eTMF Workshop）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（Pfizer CRA Workshop ）的培训，以及位葛兰素公司GSK进行ICH GCP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ICH GCP培训。

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

50.25知情同意要素78

50.27记录知情同意过程80

子部分C[保留]80

子部分D在临床研究中对儿童的额外保护80

50.50IRB责任80

50.51不高于风险的临床研究81

50.52涉及高于风险，但呈现出对受试者直接受益前景的临床研究81

50.53临床研究涉及高于风险，且对受试者没有直接有益的前景，但可能获得对受试者的机能失调或健康状况的一般性知识81

50.54只有通过进行临床研究才有机会了解、预防或减轻影响儿童健康或福祉的严重问题的临床研究82

50.55由家长或监护人代替儿童同意参加试验的要求82

50.56受监护的儿童8321CFR第54部分临床研究者财务公开85

54.1目的85

54.2定义85

54.3范围86

54.4财务证明和财务公开声明要求87

54.5FDA对财务利益的评估88

54.6保存记录及记录保留89

21CFR第56部分机构审查委员会90

子部分A总则90

56.101范围90

56.102定义90

56.103需要IRB审核的情形93

56.104豁免IRB要求94

56.105免除IRB要求94

子部分B组织和人员94

56.106登记94

56.107IRB组成成员96

子部分CIRB的功能及运营97

56.108IRB的功能及运营97

56.109IRB审核研究97

56.110快速审核程序：涉及不高于风险及对已批准的研究进行微小变更99

56.111IRB审核研究的标准99

56.112机构审查委员会审核100

56.113暂停或终止IRB对研究的批准100

56.114合作研究100

子部分D记录和报告101

56.115IRB记录101

子部分E对不依从的行政处罚102

56.120行政措施102

56.121取消IRB或研究机构的资格102

56.122公开披露撤销信息103

56.123恢复IRB或机构103

56.124取消资格的替代措施或补充措施103

21CFR第312部分研究新药申请104

子部分A一般条款104

312.1范围104

312.2适用性104

312.3定义和释义105

312.6研究新药标签107

312.7研究用药的推广107

312.8对IND下研究用药的收费107

312.10免除要求110

子部分B研究新药申请（IND）110

312.20对IND的要求110

312.21研究阶段110

312.22提交IND的一般原则111

312.23IND内容和格式112

312.30方案增补120

312.31信息增补122

312.32IND安全性报告122

312.33年度报告126

312.38撤销IND127

子部分C行政措施128

312.40在临床研究中对使用研究新药的一般要求128

312.41对IND的意见和建议128

312.42临床研究暂停和修改要求129

312.44终止132

312.45非活动状态134

312.47会议135

312.48解决争议138

子部分D申办者和研究者的责任139

312.50申办者的一般责任139

312.52向合同研究组织(CRO）转让义务139

312.53选择研究者和监查员139

312.54符合本章50.24规定的急救研究141

312.55告知研究者142

312.56审核正在进行的研究142

312.57记录保存和记录保留143

312.58对申办者记录和报告的视察143

312.59处置未使用的研究用药144

312.60研究者的一般责任144

312.61对研究用药的管控144

312.62研究者记录和记录保留144

312.64研究者报告145

312.66IRB审核的保证145

312.68对研究者记录和报告的视察145

312.69处理受管制物质146

312.70取消临床研究者的资格146

子部分E用于治疗危及生命和严重衰弱疾病的药物147

312.80目的147

312.81范围148

312.82提早咨询148

312.83治疗方案149

312.84审核用于治疗危及生命和严重衰弱疾患药物上市许可申请的风险利益分析149

312.85Ⅳ期临床研究150

312.86FDA重点监管的研究150

312.87主动监查临床研究的实施和评估150

312.88受试者安全保护150

子部分F其他150

312.110进出口要求150

312.120不受IND监管的美国以外的临床研究154

312.130公开披露IND数据和信息156

312.140通信地址157

312.145指南文件158

子部分G用于实验室动物研究和体外试验的研究用药158

312.160用于实验室动物研究和体外试验的研究用药158

子部分H[保留]160

子部分I扩展研究用药的治疗用途160

312.300总论160

312.305对扩展研究用药治疗范围的要求160

312.310个别患者，包括急救使用药物者163

312.315中等规模患者人群164

312.320治疗性IND或治疗性方案166

21CFR第812部分研究器械豁免167

子部分A一般规定167

812.1范围167

812.2适用性167

812.3定义169

812.5研究器械标签171

812.7禁止宣传和其他行为172

812.10免除要求172

812.18进出口要求173

812.19IDE通信地址173

子部分B申请和行政措施173

812.20申请173

812.25研究计划175

812.27研究前报告176

812.30FDA对申请的行动措施176

812.35补充申请178

812.36研究器械的治疗使用180

812.38数据和信息的保密183

子部分C申办者责任184

812.40申办者的一般责任184

812.42FDA和IRB批准185

812.43选择研究者和监查员185

812.45告知研究者186

812.46监查研究186

812.47本章50.24监管下的急救研究186

子部分DIRB审核和批准187

812.60IRB的组成，职责和职能187

812.62IRB批准187

812.64IRB持续审核187

812.65[保留]187

812.66重大风险器械确定187

子部分E研究者的责任188

812.100研究者的一般责任188

812.110研究者的具体责任188

812.119取消临床研究者的资格188

子部分F[保留]190

子部分G记录和报告190

812.140记录190

812.145视察192

812.150报告193

45CFR第46部分保护人类受试者196

子部分A保护人类受试者的基本卫生和公共服务（HHS）政策196

46.101政策适用范围（略）196

46.102定义196

46.103确保遵守本政策——由联邦部门或政府机构进行或支持的研究197

46.104—46.106[保留]200

46.107IRB会员资格200

46.108IRB的功能和操作201

46.109IRB审核研究201

46.110快速审核程序，涉及不高于风险的某些研究，以及批准研究的微小变更201

46.111IRB批准研究的标准202

46.112机构审核203

46.113暂停或终止IRB批准的研究203

46.114合作研究203

46.115IRB记录203

46.116知情同意的一般要求204

46.117知情同意记录206

46.118申请和提案缺乏明确的人类受试者参与计划207

46.119无意涉及人类受试者的研究207

46.120评估和处理由联邦部门或政府机构执行或支持的研究申请与提案207

46.121[保留]208

46.122使用联邦资金208

46.123提前终止研究支持：评估申请和提案208

46.124条件208

子部分B涉及孕妇、胎儿和新生儿研究的额外保护208

46.201规定适用范围？（略）208

46.202定义208

46.203IRB在涉及孕妇、胎儿和新生儿相关研究的职责209

46.204涉及孕妇或胎儿的研究209

46.205涉及新生儿的研究210

46.206研究涉及分娩后胎盘、死胎或胎儿物质211

46.207不批准研究就没有机会进行了解、预防或减轻影响孕妇、胎儿或新生儿健康或福祉的严重问题212

子部分C涉及将囚犯作为受试者的生物医学和行为研究的附加保护212

46.301适用范围（略）212

46.302目的212

46.303定义212

46.304囚犯参与研究时机构审查委员会的组成213

46.305机构审查委员会对囚犯参与研究的附加职责213

46.306允许涉及囚犯的研究214

子部分D研究中涉及儿童作为受试者的其他保护215

46.401本规定适用范围（略）215

46.402定义215

46.403IRB的职责215

46.404不涉及高于风险的研究215

46.405研究涉及的风险高于风险，但对受试者有直接受益的前景216

46.406研究涉及的风险大于风险，对个体受试者无直接受益前景，但可能获得关于受试者的疾病或病症的一般性知识216

46.407不批准研究就没有机会了解、预防或减轻影响儿童健康或福祉的严重问题216

46.408父母或监护人许可儿童参与研究的要求217

46.409受监护的儿童218

子部分E机构审查委员会的登记（略）218

ICH GUIDELINE FOR GOOD CLINICAL PRACTICE（GCP）(E6_R2)

Current Step 4 version dated 9 November 2016

Introduction221

1.Glossary222

2.The Principles of ICH GCP232

3.Institutional Review Board/Independent Ethics Committee(IRB/IEC)234

3.1Responsibilities234

3.2Composition,Functions and Operations235

3.3Procedures236

3.4Records237

4.Investigator237

4.1Investigators Qualifications and Agreements237

4.2Adequate Resources238

4.3Medical Care of Trial Subjects239

4.4Communication with IRB/IEC239

4.5Compliance with Protocol239

4.6Investigational Product(s)240

4.7Randomization Procedures and Unblinding241

4.8Informed Consent of Trial Subjects241

4.9Records and Reports246

4.10Progress Reports247

4.11Safety Reporting247

4.12Premature Termination or Suspension of a Trial248

4.13Final Report(s) by Investigator248

5.Sponsor249

5.0Quality Management249

5.1Quality Assurance and Quality Control251

5.2Contract Research Organization(CRO)251

5.3Medical Expertise251

5.4Trial Design252

5.5Trial Management,Data Handling,and Record Keeping252

5.6Investigator Selection254

5.7Allocation of Responsibilities255

5.8Compensation to Subjects and Investigators255

5.9Financing255

5.10Notification/Submission to Regulatory Authority(ies)256

5.11Confirmation of Review by IRB/IEC256

5.12Information on Investigational Product(s)256

5.13Manufacturing,Packaging,Labelling,and Coding Investigational Product(s)257

5.14Supplying and Handling Investigational Product(s)257

5.15Record Access259

5.16Safety Information259

5.17Adverse Drug Reaction Reporting259

5.18Monitoring259

5.19Audit265

5.20Noncompliance266

5.21Premature Termination or Suspension of a Trial266

5.22Clinical Trial/Study Reports266

5.23Multicentre Trials267

6.Clinical Trial Protocol and Protocol Amendment(s)267

6.1General Information267

6.2Background Information268

6.3Trial Objectives and Purpose268

6.4Trial Design268

6.5Selection and Withdrawal of Subjects269

6.6Treatment of Subjects269

6.7Assessment of Efficacy270

6.8Assessment of Safety270

6.9Statistics270

6.10Direct Access to Source Data/Documents271

6.11Quality Control and Quality Assurance271

6.12Ethics271

6.13Data Handling and Record Keeping271

6.14Financing and Insurance271

6.15Publication Policy271

6.16Supplements271

7.Investigators Brochure271

7.1Introduction271

7.2General Considerations273

7.3Contents of the Investigators Brochure273

7.4Appendix 1279

7.5Appendix 2280

8.Essential Documents for the Conduct of a Clinical Trial281

8.1Introduction281

8.2Before the Clinical Phase of the Trial Commences282

8.3During the Clinical Conduct of the Trial287

8.4After Completion or Termination of the Trial292

CODE OF FEDERAL REGULATIONS

21CFRPART11ELECTRONIC RECORDS;ELECTRONIC SIGNATURES296

Subpart A – General Provisions296

Sec.11.1Scope.296

Sec.11.2Implementation.297

Sec.11.3Definitions.297

Subpart B – Electronic Records298

Sec.11.10Controls for closed systems.298

Sec.11.30Controls for open systems.300

Sec.11.50Signature manifestations.300

Sec.11.70Signature/record linking.300

Subpart C – Electronic Signatures300

Sec.11.100General requirements.300

Sec.11.200Electronic signature components and controls.301

Sec.11.300Controls for identification codes/passwords.302

21CFRPART50PROTECTION OF HUMAN SUBJECTS303

Subpart A – General Provisions303

Sec.50.1Scope.303

Sec.50.3Definitions.303

Subpart B – Informed Consent of Human Subjects308

Sec.50.20General requirements for informed consent.308

Sec.50.23Exception from general requirements.308

Sec.50.24Exception from informed consent requirements for emergency
research.314

Sec.50.25Elements of informed consent.318

Sec.50.27Documentation of informed consent.320

Subpart C ［Reserved］321

Subpart D – Additional Safeguards for Children in Clinical Investigations321

Sec.50.50IRB duties.321

Sec.50.51Clinical investigations not involving greater than minimal risk.321

Sec.50.52Clinical investigations involving greater than minimal risk but
presenting the prospect of direct benefit to individual subjects.321

Sec.50.53Clinical investigations involving greater than minimal risk and no
prospect of direct benefit to individual subjects,but likely to yield
generalizable knowledge about the subjects disorder or
ondition.322

Sec.50.54Clinical investigations not otherwise approvable that present an
opportunity to understand, prevent,or alleviate a serious problem affecting the
health or welfare of children.322

Sec.50.55Requirements for permission by parents or guardians and for assent by
children.323

Sec.50.56Wards.324

21CFRPART54FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS326Sec.54.1Purpose.326

Sec.54.2Definitions.326

Sec.54.3Scope.328

Sec.54.4Certification and disclosure requirements.328

Sec.54.5Agency evaluation of financial interests.330

Sec.54.6Recordkeeping and record retention.331

21CFRPART56INSTITUTIONAL REVIEW BOARDS332

Subpart A-General Provisions332

Sec.56.101Scope.332

Sec.56.102Definitions.332

Sec.56.103Circumstances in which IRB review is required.336

Sec.56.104Exemptions from IRB requirement.337

Sec.56.105Waiver of IRB requirement.337

Subpart B-Organization and Personnel337

Sec.56.106Registration.337

Sec.56.107IRB membership.339

Subpart C-IRB Functions and Operations340

Sec.56.108IRB functions and operations.340

Sec.56.109IRB review of research.341

Sec.56.110Expedited review procedures for certain kinds of research involving
no more than minimal risk,and for minor changes in approved research.343

Sec.56.111Criteria for IRB approval of research.343

Sec.56.112Review by institution.344

Sec.56.113Suspension or termination of IRB approval of research.345

Sec.56.114Cooperative research.345

Subpart D-Records and Reports345

Sec.56.115IRB records.345

Subpart E-Administrative Actions for Noncompliance346

Sec.56.120Lesser administrative actions.346

Sec.56.121Disqualification of an IRB or an institution.347

Sec.56.122Public disclosure of information regarding revocation.348

Sec.56.123Reinstatement of an IRB or an institution.348

Sec.56.124Actions alternative or additional to disqualification.348

21CFRPART312INVESTIGATIONAL NEW DRUG APPLICATION349Subpart A-General
Provisions349

Sec.312.1Scope.349

Sec.312.2Applicability.349

Sec.312.3Definitions and interpretations.351

Sec.312.6Labeling of an investigational new drug.352

Sec.312.7Promotion of investigational drugs.353

Sec.312.8Charging for investigational drugs under an IND.353

Sec.312.10Waivers.356

Subpart B-Investigational New Drug Application(IND)357

Sec.312.20Requirement for an IND.357

Sec.312.21Phases of an investigation.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’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 minimal risk.487

46.405Research involving greater than minimal risk but presenting the prospect
of direct benefit to the individual subjects.487

46.406Research involving greater than minimal risk and no prospect of direct
benefit to individual subjects,but likely to yield generalizable knowledge
about the subjects disorder or condition.488

46.407Research not otherwise approvable which presents an opportunity to understand,prevent,or
alleviate a serious problem affecting the health or welfare of children.488

46.408Requirements for permission by parents or guardians and for assent by
children.489

46.409Wards.490

Subpart E-Registration of  Institutional
Review Boards (Omit)491

2017年6月，中国成为国际人用药品注册技术协调会正式成员，我国真正融入国际药品监管体系。近些年来在海外开展临床试验的中国境内药企不再是凤毛麟角，国内开展的临床试验也逐步向国际标准看齐，越来越多药物研发从业人员加入学习、实践临床试验国际化标准的队伍。顺应时势需要，我们就临床试验中经常涉及的问题选择翻译了ICH GCP（E6_R2），美国联邦法案21CFR中关于电子记录/电子签名、保护人类受试者、临床研究者财务公开、机构审查委员会、研究新药申请、研究器械豁免以及美国联邦法规45CFR中关于保护人类受试者部分，以供有志于中国临床试验发展的同行们共同学习。翻译过程中难免出现错误疏忽之处，敬请指正。后附英文原文，以便大家对照学习。

特别致谢：中南大学湘雅二医院内分泌科颜湘医生与浙江大学附属医院血液科孙洁医生在繁重的医疗工作中抽出时间对翻译稿进行校正。

声明：本书中文译文非ICH和FDA官方认可的翻译文件。

陈东

2018年6月