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。

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 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不高于最低风险的临床研究81 50.52涉及高于最低风险，但呈现出对受试者直接受益前景的临床研究81 50.53临床研究涉及高于最低风险，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：涉及不高于最低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，涉及不高于最低风险的某些研究，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不涉及高于最低风险的研究215 46.405研究涉及的风险高于最低风险，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最低风险，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

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