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CRP-1015 Study Start Up

CRP-1015 Study Start Up


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CRP-1021 Project Accounting

CRP-1021 Project Accounting


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CRP-1022 Project Management

CRP-1022 Project Management


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CRP-1023 Protocol Implementation

CRP-1023 Protocol Implementation


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CRP-1024 Inspections by Regulatory Authorities

CRP-1024 Inspections by Regulatory Authorities


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CRP-1025 Quality Control/Quality Assurance Audits

CRP-1025 Quality Control/Quality Assurance Audits


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CRP-1036 Clinical Trial Personnel Qualifications

CRP-1036 Clinical Trial Personnel Qualifications


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CRP-1037 Clinical Trial Unblinding: VRC705

CRP-1037 Clinical Trial Unblinding: VRC705


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CRP-1001 Clinical Research Process

CRP-1001 Clinical Research Process


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CRP-1002 Authorship Guidelines Policy

CRP-1002 Authorship Guidelines Policy


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CRP-1006 Education & Training

CRP-1006 Education & Training


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CRP-1008 Roles & Responsibilities of Investigators and Research Staff

CRP-1008 Roles & Responsibilities of Investigators and Research Staff


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CRP-1010 Intellectual Property Policy

CRP-1010 Intellectual Property Policy


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CRP-1012 Providing Emergency Medical Care to Clinical Trial Participants

CRP-1012 Providing Emergency Medical Care to Clinical Trial Participants


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CRP-1013 Clinical Data Management

CRP-1013 Clinical Data Management


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CRP-1014 Electronic Data Management Systems

CRP-1014 Electronic Data Management Systems


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Research Compliance

CRP-1035 SOP and Policy Development and Version Control

CRP-1035 SOP and Policy Development and Version Control


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CRP-1039 Ethical and Regulatory Mandates to Protect Human Research Participants

CRP-1039 Ethical and Regulatory Mandates to Protect Human Research Participants


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CRP-1041 Purpose of the Office of Human Research Protection Program and Institutional Review Board

CRP-1041 Purpose of the Office of Human Research Protection Program and Institutional Review Board


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CRP-1042 Management of the Office of Human Research Protection Program and IRB

CRP-1042 Management of the Office of Human Research Protection Program and IRB


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CRP-1043 Institutional Review Board Committee Membership

CRP-1043 Institutional Review Board Committee Membership


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CRP-1044 Considerations for Special Subject Populations

CRP-1044 Considerations for Special Subject Populations


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CRP-1045 Reporting of IRB Determinations

CRP-1045 Reporting of IRB Determinations


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CRP-1046 Suspensions and Terminations

CRP-1046 Suspensions and Terminations


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CRP-1008 Roles & Responsibilities of Investigators and Research Staff

CRP-1008 Roles & Responsibilities of Investigators and Research Staff


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CRP-1047 IRB Recordkeeping and Retention

CRP-1047 IRB Recordkeeping and Retention


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CRP-1024 Inspections by Regulatory Authorities

CRP-1024 Inspections by Regulatory Authorities


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CRP-1048 Reporting Concerns and Undue Influence

CRP-1048 Reporting Concerns and Undue Influence


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CRP-1005 Clinical Research Program Signatory Authority

CRP-1005 Clinical Research Program Signatory Authority


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CRP-1049 Reliance Mechanisms

CRP-1049 Reliance Mechanisms


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CRP-1007 Essential Documents for the Conduct of a Clinical Trial

CRP-1007 Essential Documents for the Conduct of a Clinical Trial


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CRP-1056 Institutional Review Board General Procedures

CRP-1056 Institutional Review Board General Procedures


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CRP-1009 Conflict of Interest for Clinical Investigators

CRP-1009 Conflict of Interest for Clinical Investigators


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CRP-1057 Institutional Review Board Convened IRB Research

CRP-1057 Institutional Review Board Convened IRB Research


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CRP-1011 Responsibility and Delegation of Responsibility in Clinical Research

CRP-1011 Responsibility and Delegation of Responsibility in Clinical Research


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CRP-1058 Institutional Review Board Exempt Research

CRP-1058 Institutional Review Board Exempt Research


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CRP-1030 Informed Consent

CRP-1030 Informed Consent


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CRP-1059 Institutional Review Board Expedited Research

CRP-1059 Institutional Review Board Expedited Research


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CRP-1031 Protecting Confidential Information

CRP-1031 Protecting Confidential Information


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CRP-1060 Institutional Review Board Subject recruitment and advertisements

CRP-1060 Institutional Review Board Subject recruitment and advertisements


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Research Compliance

CRP-1025 Quality Control/Quality Assurance Audits

CRP-1025 Quality Control/Quality Assurance Audits


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CRP-1049 Reliance Mechanisms

CRP-1049 Reliance Mechanisms


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CRP-1036 Clinical Trial Personnel Qualifications

CRP-1036 Clinical Trial Personnel Qualifications


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CRP-1003 Transportation of Ambient Investigational Medicinal Products

CRP-1003 Transportation of Ambient Investigational Medicinal Products


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CRP-1037 Clinical Trial Unblinding: VRC705

CRP-1037 Clinical Trial Unblinding: VRC705


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CRP-1004 Transportation of Refrigerated Investigational Medicinal Products

CRP-1004 Transportation of Refrigerated Investigational Medicinal Products


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CRP-1009 Conflict of Interest for Clinical Investigators

CRP-1009 Conflict of Interest for Clinical Investigators


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CRP-1016 Inventory/Investigational Product Management

CRP-1016 Inventory/Investigational Product Management


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CRP-1011 Responsibility and Delegation of Responsibility in Clinical Research

CRP-1011 Responsibility and Delegation of Responsibility in Clinical Research


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CRP-1017 Monitoring Visits

CRP-1017 Monitoring Visits


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CRP-1030 Informed Consent

CRP-1030 Informed Consent


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CRP-1018 Source Documentation

CRP-1018 Source Documentation


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CRP-1031 Protecting Confidential Information

CRP-1031 Protecting Confidential Information


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CRP-1019 Specimen Collection, Labeling & Handling

CRP-1019 Specimen Collection, Labeling & Handling


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CRP-1035 SOP and Policy Development and Version Control

CRP-1035 SOP and Policy Development and Version Control


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CRP-1020 Study Closeout Visit

CRP-1020 Study Closeout Visit


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CRP-1012 Providing Emergency Medical Care to Clinical Trial Participants

CRP-1012 Providing Emergency Medical Care to Clinical Trial Participants


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CRP-1039 Ethical and Regulatory Mandates to Protect Human Research Participants

CRP-1039 Ethical and Regulatory Mandates to Protect Human Research Participants


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CRP-1026 Maintenance of All Study-Related Documents

CRP-1026 Maintenance of All Study-Related Documents


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CRP-1013 Clinical Data Management

CRP-1013 Clinical Data Management


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CRP-1041 Purpose of the Office of Human Research Protection Program and Institutional Review Board

CRP-1041 Purpose of the Office of Human Research Protection Program and Institutional Review Board


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CRP-1027 Subject Management

CRP-1027 Subject Management


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CRP-1014 Electronic Data Management Systems

CRP-1014 Electronic Data Management Systems


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CRP-1042 Management of the Office of Human Research Protection Program and IRB

CRP-1042 Management of the Office of Human Research Protection Program and IRB


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CRP-1028 Adverse Event Management

CRP-1028 Adverse Event Management


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CRP-1015 Study Start Up

CRP-1015 Study Start Up


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CRP-1044 Considerations for Special Subject Populations

CRP-1044 Considerations for Special Subject Populations


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CRP-1029 Eligibility and Enrollment

CRP-1029 Eligibility and Enrollment


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CRP-1021 Project Accounting

CRP-1021 Project Accounting


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CRP-1045 Reporting of IRB Determinations

CRP-1045 Reporting of IRB Determinations


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CRP-1032 Subject Recruitment and Screening

CRP-1032 Subject Recruitment and Screening


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CRP-1022 Project Management

CRP-1022 Project Management


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CRP-1046 Suspensions and Terminations

CRP-1046 Suspensions and Terminations


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CRP-1033 Subject Visits and Assessments

CRP-1033 Subject Visits and Assessments


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CRP-1023 Protocol Implementation

CRP-1023 Protocol Implementation


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CRP-1047 IRB Recordkeeping and Retention

CRP-1047 IRB Recordkeeping and Retention


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CRP-1034 Clinical Quality Management Plans

CRP-1034 Clinical Quality Management Plans


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CRP-1024 Inspections by Regulatory Authorities

CRP-1024 Inspections by Regulatory Authorities


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CRP-1048 Reporting Concerns and Undue Influence

CRP-1048 Reporting Concerns and Undue Influence


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CRP-1038 Handling of Laboratory Results

CRP-1038 Handling of Laboratory Results


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