SOPs

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Standard Operating Procedures

Protocol Life-Cycle Actions
UWZ-002.03 Scientific Review of Human Subjects Research Protocols
SRC Scientific Review Process FINAL

UWS-HP-603.03 Conducting Initial Review of Human Subjects Research
UWS-HP-603.03 Appendix A1 PEF
UWS-HP-603.03 Appendix A2 Abbreviated PEF
UWS-HP-603.03 Appendix A3 WRAIR IRB Protocol Checklist
UWS-HP-603.03 Appendix A4a WRAIR IRB Consent From Template
UWS-HP-603.02 Appendix A4b Informed Consent Form Template
UWS-HP-603.03 Appendix A5 Qualifications Summary
UWS-HP-603.03 Appendix A6 Limited IRB Review
UWS-HP-603.03 Appendix A7 Data Security Form

UWS-HP-615 03 Amendments to HSR

UWS-HP-618.03 Continuing Review SOP
UWS-HP-618.03 Appendix 1 – Continuing Review Notifications
UWS-HP-618.03 Appendix 2a – Continuing Review Application
UWS-HP-618.03 Appendix 2b – Abbreviated Continuing Review Application
UWS-HP-618.03 Appendix 3 – HSPB and IRB Member Continuing Review Worksheet
IRB Processes & Procedures
WRAIR IRB - Fully Constituted Board
UWS-HP-605.04 Humanitarian Use Devices
UWS-HP-606.04 SOP Non-Compliance
UWS-HP-606.04 A Intake Form
UWS-HP-606.04 B Non-Compliance Report
UWS-HP-606.04 C Non-Compliance Process Checklist
UWS-HP-609.05 Conflicts of Interest
UWS-HP-609.04 Conflicts of Interest Appendix A
UWS-HP-609.05 Conflicts of Interest Appendix B
UWS-HP-610 05 IRB Meetings and Voting Requirements
UWS-H-610 05-Form A-WRAIR IRB Non Disclosure Form
UWS-C-612.05 Appeal of IRB Decisions
UWS-C-613.05 Expedited Protocol Review
UWS-HP-613.05 - Appendix A Expedited Review Categories
UWS-HP-613.05 - Appendix B Expedited Review Checklist

UWS-HP-615 03 Amendments to HSR

UWS-HP-617 Waiver or Alteration of Informed Consent for Minimal Risk Research

UWS-HP-618.04 Continuing Review SOP
UWS-HP-618.03 Appendix 1 Continuing Review Notifications
UWS-HP-618.03 Appendix 2A Continuing Review Application
UWS-HP-618.03 Appendix 2B Abbreviated Continuing Review Application
UWS-HP-618.03 Appendix 3 – HSPB and IRB Member Continuing Review Worksheet

UWS-HP-619.06 Safety Reporting for Clinical Trials
UWS-HP-621.04 Deviations and Unanticipated Problem Reporting SOP
UWS-HP-621.04 Appendix A Deviation Form
UWS-HP-621.04 Appendix B
UWS-HP-621.04 Appendix C
UWS-HP-621.04 Appendix D

UWS-HP-628.03 Review of Human Subjects Research by the Fully Convened WRAIR IRB
UWS-HP-628.03 Appendix A
UWS-HP-628.03 Appendix B
UWS-HP-628.03 Appendix C
UWS-HP-628.03 Appendix D
UWS-HP-628.03 Appendix E
UWS-HP-628.03 Appendix F
UWS-HP-637.00 Closure SOP
UWS-HP-637.00 Appendix A Close out Application Form
UWS-HP-637.00 Appendix B Closeout Report Public Health Activities
UWS-HP-637.00 Appendix C Closeout Report NHSR and NR Studies
UWS-HP-637.00 Appendix D Withdrawal of Protocol

UWS-HP-638.01 Progress Reports SOP
UWS-HP-638.01 Appendix A Progress Reports Notifications
UWS-HP-638.01 Appendix B Progress Reports Template
UWS-HP-638.01 Appendix C Adverse Event Tracking Log
UWS-HP-638.01 Appendix D Deviation Tracking Log
Compliance Monitoring
UWS-HP-633 Post Approval Monitoring
UWS-HP-633 Appendix A Post Approval Monitoring Visit Report Template
UWZ-C-633 Appendix B Worksheet for Documenting Monitoring in HSPB Database
UWS-HP-633 Appendix C Query and Clarification Form
UWS-HP-633 Appendix D Risk Assessment Tool
Recruitment & Consent Process
UWS-HP-608.04 Waiver of IC in GTMR Emergency Research
UWS-HP-627.03 Review of Recruitment Processes and Materials
UWS-HP-627.02-A-01
UWS-HP-627.02-B-01

More
Specific Types of Research
UWS-HP-604.04 Expanded Access to Investigational Product SOP
UWS-HP-607.04 Emergency Use SOP
Additional Considerations
UWZ-C-624.01 Working with Other Institutions Engaged in Research (Assurances, IAAs, & Deferrals)

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