Standard Operating Procedures for Clinical Trials

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Standard Operating Procedures for Clinical Trials

SOP Title
   
General Administration (GA)
GA-101.02 SOP on SOPs: Preparing, Maintaining and Training
GA-102.02 Sponsor Responsibility and Delegation of Responsibility
GA-103.02 Training and Education
GA-104.01 Document Development and Change Control
   
Study Start-Up (SS)
SS-201.04 Assessing Protocol Feasibility
SS-202.01 Investigator Selection
SS-203.02 Pre-Study Site Visit (PSSV)
   
Study Management (SM)
SM-301.01 Communication
SM-303.02 Documentation and Records Retention
SM-304.01 Routine Monitoring Visits
SM-305.01 Closeout Visits
SM-306.01 Adverse Event Reporting
SM-307.01 Investigational Product Management
SM-308.02 Specimen Management
   
Data Management (DM)
DM-401.01 Data Management
   
Privacy Practices (PP)
PP-501.01 Safeguarding Protected Health Information
   
Quality Assurance (QA)
QA-601.02 FDA or Pharmaceutical Sponsored Audits
   

Last Updated: 2/18/2021 2:46:25 PM

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