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Policies
Research Operations
CRP-1001 Clinical Research Process
CRP-1001 Clinical Research Process
CRP-1001_DHR_Clinical_Research_Process
CRP-1002 Authorship Guidelines Policy
CRP-1002 Authorship Guidelines Policy
CRP-1002-Authorship-Guidelines-Policy
CRP-1006 Education & Training
CRP-1006 Education & Training
CRP-1006-Clinical-Research-General-Administration_Training-and-Education
CRP-1008 Roles & Responsibilities of Investigators and Research Staff
CRP-1008 Roles & Responsibilities of Investigators and Research Staff
CRP-1008-Clinical-Research-General-Administration_Principal-Investigator-Oversight
CRP-1010 Intellectual Property Policy
CRP-1010 Intellectual Property Policy
CRP-1010-Intellectual-Property-Policy
CRP-1012 Providing Emergency Medical Care to Clinical Trial Participants
CRP-1012 Providing Emergency Medical Care to Clinical Trial Participants
CRP-1012-Providing-Emergency-Medical-Care-to-Clinical-Trial-Participants
CRP-1013 Clinical Data Management
CRP-1013 Clinical Data Management
CRP-1013-Clinical-Data-Management
CRP-1014 Electronic Data Management Systems
CRP-1014 Electronic Data Management Systems
CRP-1014-Electronic-Data-Management-Systems
CRP-1015 Study Start Up
CRP-1015 Study Start Up
CRP-1015-Study-Start-Up
CRP-1021 Project Accounting
CRP-1021 Project Accounting
CRP-1021-Clinical-Research-Project-Management_Project-Accounting
CRP-1022 Project Management
CRP-1022 Project Management
CRP-1022-Clinical-Research-Project-Management_Project-Management_Final
CRP-1023 Protocol Implementation
CRP-1023 Protocol Implementation
CRP-1023-Clinical-Research-Project-Management_Protocol-Implementation_Final
CRP-1024 Inspections by Regulatory Authorities
CRP-1024 Inspections by Regulatory Authorities
CRP-1024-Clinical-Research-Quality-Assurance_Inspections-of-Regulatory-Authorities_Final-AED
CRP-1025 Quality Control/Quality Assurance Audits
CRP-1025 Quality Control/Quality Assurance Audits
CRP-1025-Clinical-Research-Quality-Assurance_Quality-Control-and-Quality-Assurance-Audits
CRP-1036 Clinical Trial Personnel Qualifications
CRP-1036 Clinical Trial Personnel Qualifications
CRP-1036_VRC705_Personnel-Qualifications
CRP-1037 Clinical Trial Unblinding: VRC705
CRP-1037 Clinical Trial Unblinding: VRC705
CRP-1037_VRC705_Unblinding-for-Safety
Research Compliance
CRP-1008 Roles & Responsibilities of Investigators and Research Staff
CRP-1008 Roles & Responsibilities of Investigators and Research Staff
CRP-1008-Clinical-Research-General-Administration_Principal-Investigator-Oversight
CRP-1024 Inspections by Regulatory Authorities
CRP-1024 Inspections by Regulatory Authorities
CRP-1024-Clinical-Research-Quality-Assurance_Inspections-of-Regulatory-Authorities_Final-AED
CRP-1005 Clinical Research Program Signatory Authority
CRP-1005 Clinical Research Program Signatory Authority
CRP-1005-Clinical-Research-Regulatory-Affairs_Signatory-Authority
CRP-1007 Essential Documents for the Conduct of a Clinical Trial
CRP-1007 Essential Documents for the Conduct of a Clinical Trial
CRP-1007-Clinical-Research-Regulatory-Affairs_Essential-Documents
CRP-1009 Conflict of Interest for Clinical Investigators
CRP-1009 Conflict of Interest for Clinical Investigators
CRP-1009-Clinical-Research-Regulator-Affairs_Conflict-of-Interest-for-Clinical-Investigators
CRP-1011 Responsibility and Delegation of Responsibility in Clinical Research
CRP-1011 Responsibility and Delegation of Responsibility in Clinical Research
CRP-1011-Clinical-Research-General-Administration_Responsibility-and-Delegation-of-Responsibility-in-Clinical-Research
CRP-1030 Informed Consent
CRP-1030 Informed Consent
CRP-1030-Clinical-Research-Subject-Management_Informed-Consent
CRP-1031 Protecting Confidential Information
CRP-1031 Protecting Confidential Information
CRP-1031-Clinical-Research-Subject-Management_Protecting-Confidential-Information-Final-AED-Draft
CRP-1035 SOP and Policy Development and Version Control
CRP-1035 SOP and Policy Development and Version Control
CRP-1035_VRC705_SOP-Development-and-Version-Control
CRP-1039 Ethical and Regulatory Mandates to Protect Human Research Participants
CRP-1039 Ethical and Regulatory Mandates to Protect Human Research Participants
CRP-1039_Ethical-And-Regulatory-Mandates-to-Protect-Human-Research-Participants
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
CRP-1041_Purpose-of-the-office-of-Human-Research-Protection-program-and-Institutional-Review-Board
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
CRP-1042_Management-of-the-office-of-human-research-protection-program-and-IRB
CRP-1043 Institutional Review Board Committee Membership
CRP-1043 Institutional Review Board Committee Membership
CRP-1043_Institutional-Review-Board-Committee-Membership
CRP-1044 Considerations for Special Subject Populations
CRP-1044 Considerations for Special Subject Populations
CRP-1044_Considerations-for-Special-Subject-Populations
CRP-1045 Reporting of IRB Determinations
CRP-1045 Reporting of IRB Determinations
CRP-1045_-Reporting-of-IRB-Determinations
CRP-1046 Suspensions and Terminations
CRP-1046 Suspensions and Terminations
CRP-1046_Suspensions-and-Terminations
CRP-1047 IRB Recordkeeping and Retention
CRP-1047 IRB Recordkeeping and Retention
CRP-1047_IRB-Recordkeeping-and-Retention
CRP-1048 Reporting Concerns and Undue Influence
CRP-1048 Reporting Concerns and Undue Influence
CRP-1048_Reporting-Concerns-and-Undue-Influence
CRP-1049 Reliance Mechanisms
CRP-1049 Reliance Mechanisms
CRP-1049_Reliance-Mechanisms
CRP-1056 Institutional Review Board General Procedures
CRP-1056 Institutional Review Board General Procedures
CRP-1056_Institutional-Review-Board-General-Procedures
CRP-1057 Institutional Review Board Convened IRB Research
CRP-1057 Institutional Review Board Convened IRB Research
CRP-1057_Institutional-Review-Board-Convened-IRB-Research
CRP-1058 Institutional Review Board Exempt Research
CRP-1058 Institutional Review Board Exempt Research
CRP-1058_Institutional-Review-Board-Exempt-Research
CRP-1059 Institutional Review Board Expedited Research
CRP-1059 Institutional Review Board Expedited Research
CRP-1059_Institutional-Review-Board-Expedited-Research
CRP-1060 Institutional Review Board Subject recruitment and advertisements
CRP-1060 Institutional Review Board Subject recruitment and advertisements
CRP-1060_Institutional-Review-Board-Subject-recruitment-and-advertisements
Research Compliance
CRP-1012 Providing Emergency Medical Care to Clinical Trial Participants
CRP-1012 Providing Emergency Medical Care to Clinical Trial Participants
CRP-1012-Providing-Emergency-Medical-Care-to-Clinical-Trial-Participants
CRP-1013 Clinical Data Management
CRP-1013 Clinical Data Management
CRP-1013-Clinical-Data-Management
CRP-1014 Electronic Data Management Systems
CRP-1014 Electronic Data Management Systems
CRP-1014-Electronic-Data-Management-Systems
CRP-1015 Study Start Up
CRP-1015 Study Start Up
CRP-1015-Study-Start-Up
CRP-1021 Project Accounting
CRP-1021 Project Accounting
CRP-1021-Clinical-Research-Project-Management_Project-Accounting
CRP-1022 Project Management
CRP-1022 Project Management
CRP-1022-Clinical-Research-Project-Management_Project-Management_Final
CRP-1023 Protocol Implementation
CRP-1023 Protocol Implementation
CRP-1023-Clinical-Research-Project-Management_Protocol-Implementation_Final
CRP-1024 Inspections by Regulatory Authorities
CRP-1024 Inspections by Regulatory Authorities
CRP-1024-Clinical-Research-Quality-Assurance_Inspections-of-Regulatory-Authorities_Final-AED
CRP-1025 Quality Control/Quality Assurance Audits
CRP-1025 Quality Control/Quality Assurance Audits
CRP-1025-Clinical-Research-Quality-Assurance_Quality-Control-and-Quality-Assurance-Audits
CRP-1036 Clinical Trial Personnel Qualifications
CRP-1036 Clinical Trial Personnel Qualifications
CRP-1036_VRC705_Personnel-Qualifications
CRP-1037 Clinical Trial Unblinding: VRC705
CRP-1037 Clinical Trial Unblinding: VRC705
CRP-1037_VRC705_Unblinding-for-Safety
CRP-1009 Conflict of Interest for Clinical Investigators
CRP-1009 Conflict of Interest for Clinical Investigators
CRP-1009-Clinical-Research-Regulator-Affairs_Conflict-of-Interest-for-Clinical-Investigators
CRP-1011 Responsibility and Delegation of Responsibility in Clinical Research
CRP-1011 Responsibility and Delegation of Responsibility in Clinical Research
CRP-1011-Clinical-Research-General-Administration_Responsibility-and-Delegation-of-Responsibility-in-Clinical-Research
CRP-1030 Informed Consent
CRP-1030 Informed Consent
CRP-1030-Clinical-Research-Subject-Management_Informed-Consent
CRP-1031 Protecting Confidential Information
CRP-1031 Protecting Confidential Information
CRP-1031-Clinical-Research-Subject-Management_Protecting-Confidential-Information-Final-AED-Draft
CRP-1035 SOP and Policy Development and Version Control
CRP-1035 SOP and Policy Development and Version Control
CRP-1035_VRC705_SOP-Development-and-Version-Control
CRP-1039 Ethical and Regulatory Mandates to Protect Human Research Participants
CRP-1039 Ethical and Regulatory Mandates to Protect Human Research Participants
CRP-1039_Ethical-And-Regulatory-Mandates-to-Protect-Human-Research-Participants
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
CRP-1041_Purpose-of-the-office-of-Human-Research-Protection-program-and-Institutional-Review-Board
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
CRP-1042_Management-of-the-office-of-human-research-protection-program-and-IRB
CRP-1044 Considerations for Special Subject Populations
CRP-1044 Considerations for Special Subject Populations
CRP-1044_Considerations-for-Special-Subject-Populations
CRP-1045 Reporting of IRB Determinations
CRP-1045 Reporting of IRB Determinations
CRP-1045_-Reporting-of-IRB-Determinations
CRP-1046 Suspensions and Terminations
CRP-1046 Suspensions and Terminations
CRP-1046_Suspensions-and-Terminations
CRP-1047 IRB Recordkeeping and Retention
CRP-1047 IRB Recordkeeping and Retention
CRP-1047_IRB-Recordkeeping-and-Retention
CRP-1048 Reporting Concerns and Undue Influence
CRP-1048 Reporting Concerns and Undue Influence
CRP-1048_Reporting-Concerns-and-Undue-Influence
CRP-1049 Reliance Mechanisms
CRP-1049 Reliance Mechanisms
CRP-1049_Reliance-Mechanisms
CRP-1003 Transportation of Ambient Investigational Medicinal Products
CRP-1003 Transportation of Ambient Investigational Medicinal Products
CRP-1003_Transportation_of_Ambient_Investigational_Medicinal_Products-17Oct2017
CRP-1004 Transportation of Refrigerated Investigational Medicinal Products
CRP-1004 Transportation of Refrigerated Investigational Medicinal Products
CRP-1004-Transportation-to-Refrigerated-Investigation-Medicinal-Products
CRP-1016 Inventory/Investigational Product Management
CRP-1016 Inventory/Investigational Product Management
CRP-1016-Inventory-Investigation-Product-Management
CRP-1017 Monitoring Visits
CRP-1017 Monitoring Visits
CRP-1017-Monitoring-Visits
CRP-1018 Source Documentation
CRP-1018 Source Documentation
CRP-1018-Source-Documentation
CRP-1019 Specimen Collection, Labeling & Handling
CRP-1019 Specimen Collection, Labeling & Handling
CRP-1019-Specimen-Collection-Handling
CRP-1020 Study Closeout Visit
CRP-1020 Study Closeout Visit
CRP-1020-Study-Closeout-Visit
CRP-1026 Maintenance of All Study-Related Documents
CRP-1026 Maintenance of All Study-Related Documents
CRP-1026-Clinical-Research-Regulatory-Affairs_Maintenance-of-Study-Related-Documents
CRP-1027 Subject Management
CRP-1027 Subject Management
CRP-1027-Clinical-Research-Subject-Management_Subject-Management_Final
CRP-1028 Adverse Event Management
CRP-1028 Adverse Event Management
CRP-1028-Clinical-Research-Subject-Management_Adverse-Event-Management
CRP-1029 Eligibility and Enrollment
CRP-1029 Eligibility and Enrollment
CRP-1029-Clinical-Research-Subject-Management_Eligibility-and-Enrollment
CRP-1032 Subject Recruitment and Screening
CRP-1032 Subject Recruitment and Screening
CRP-1032-Clinical-Research-Subject-Management_Subject-Recruitment-and-Screening_ML_Comments
CRP-1033 Subject Visits and Assessments
CRP-1033 Subject Visits and Assessments
CRP-1033-Clinical-Research-Subject-Management_Subject-Visits-and-Assessments
CRP-1034 Clinical Quality Management Plans
CRP-1034 Clinical Quality Management Plans
CRP-1034-Clinical-Research-Quality-Data-Management-Plan_ML_Comments
CRP-1038 Handling of Laboratory Results
CRP-1038 Handling of Laboratory Results
CRP-1038_VRC705_Handling-of-Lab-Results
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