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Standard Operating Procedures



SOP Title
   
General Administration (GA) 
GA-101.01 SOP on SOPs: Preparing, Maintaining and Training
GA-102.01 Sponsor Responsibility and Delegation of Responsibility
GA-103.01 Training and Education
GA-104.00 Document Development and Change Control
   
Study Start-Up (SS) 
SS-201.02 Assessing Protocol Feasibility
SS-202.00 Investigator Selection
SS-203.01 Pre-Study Site Visit (PSSV)
SS-204.01 Site Initiation Visit (SIV)
   
Study Management (SM) 
SM-301.00 Communication
SM-302.00 Interactions with the Institutional Review Board (IRB)
SM-303.01 Documentation and Records Retention
SM-304.00 Routine Monitoring Visits
SM-305.00 Closeout Visits
SM-306.00 Adverse Event Reporting
SM-307.01 Investigational Product Management
SM-308.01 Specimen Management
   
Data Management (DM) 
DM-401.00 Data Management
   
Privacy Practices (PP) 
PP-501.00 Safeguarding Protected Health Information
   
Quality Assurance (QA) 
QA-601.01 Audits by Third Parties
   
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