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SoCRASociety of Clinical Research Association的CCRPCertified Clinical Research Professional认证和PMIProject Management Institution 的PMPProject 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。
Sec.11.200Electronic signature components and controls.301
Sec.11.300Controls for identification codespasswords.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 ApplicationIND357
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 sponsors 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.312.320Treatment 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
812.64IRBs 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?Omit463
46.102Definitions.463
46.103Assuring compliance with this policyresearch conducted or supported by any Federal Department or Agency.465
46.10446.106 [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? Omit478
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
46.301ApplicabilityOmit. 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?Omit486
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 Omit491
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