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Institutional Review Board
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POLICY ON THE CONDUCT OF RESEARCH
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POLICY ON THE CONDUCT OF RESEARCH
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SOP Chapter 1
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1.1 Appointment of IRB Members
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1.1 Appointment of IRB Members
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1.2 Appointment of Independent Consultants
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1.2 Appointment of Independent Consultants
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1.3 Training of IRB Members and Staff
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1.3 Training of IRB Members and Staff
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SOP Chapter 2
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2.1 Management of Initial Protocol Submissions
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2.1 Management of Initial Protocol Submissions
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2.2 Use of Study Assessment Forms
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2.2 Use of Study Assessment Forms
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2.3 Exempt from Review
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2.3 Exempt from Review
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2.4 Expedited Review
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2.4 Expedited Review
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2.5 Full Board Review of Submitted Protocols
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2.5 Full Board Review of Submitted Protocols
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2.6 Review of Resubmission
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2.6 Review of Resubmission
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SOP Chapter 3
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3.1 Review of Protocol Amendment
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3.1 Review of Protocol Amendment
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3.2 Review of Progress Report
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3.2 Review of Progress Report
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3.3 Review of Final Report
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3.3 Review of Final Report
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3.4 Review of Serious Adverse Event
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3.4 Review of Serious Adverse Event
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3.5 Review of Protocol Violation Deviation
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3.5 Review of Protocol Violation Deviation
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3.6 Continuting Review
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3.6 Continuting Review
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3.7 Responding to Participants Request Query
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3.7 Responding to Participants Request Query
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3.8 Site Visits
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3.8 Site Visits
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3.9 Review of Early Protocol Termination
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3.9 Review of Early Protocol Termination
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SOP Chapter 4
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4.1 Preparation of Meeting Agenda
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4.1 Preparation of Meeting Agenda
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4.2 Conduct of a Full Board Meeting
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4.2 Conduct of a Full Board Meeting
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4.3 Preparation of Meeting Minutes
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4.3 Preparation of Meeting Minutes
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4.4 Communicating IRB Decision to PI
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4.4 Communicating IRB Decision to PI
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4.5 Management of IRB Communications
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4.5 Management of IRB Communications
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4.6 Management of Active Study Files
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4.6 Management of Active Study Files
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4.7 Archiving of Inactive Study Files
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4.7 Archiving of Inactive Study Files
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4.8 Maintenance of Confidentiality of Study Files and IRB Documents
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4.8 Maintenance of Confidentiality of Study Files and IRB Documents
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SOP Chapter 5
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5.1 Writing SOPs
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5.1 Writing SOPs
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5.2 Revising SOPs
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5.2 Revising SOPs
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