Standard Operating Procedures - SOP-01
Standard Operating Procedures - SOP-01
Standard Operating Procedures - SOP-01
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<strong>Standard</strong> <strong>Operating</strong> <strong>Procedures</strong> (<strong>SOP</strong>)<strong>SOP</strong>-<strong>01</strong>Development, Approval and Reviewof <strong>Standard</strong> <strong>Operating</strong> <strong>Procedures</strong>
<strong>SOP</strong>-<strong>01</strong>Development, Approval and Review of <strong>Standard</strong> <strong>Operating</strong> <strong>Procedures</strong>• Objective– Define:• The development of site standard operating procedures;• The <strong>SOP</strong> approval/validation process;• The implementation of <strong>SOP</strong>s within the institution;• The management and updating of <strong>SOP</strong>s.
<strong>SOP</strong>-<strong>01</strong>Development, Approval and Review of <strong>Standard</strong> <strong>Operating</strong> <strong>Procedures</strong>• Site responsibilities– Research Center Director– Sponsor-Investigator or Investigator/Qualified Investigator– Person responsible for the Site <strong>SOP</strong>s
<strong>SOP</strong>-<strong>01</strong>Development, Approval and Review of <strong>Standard</strong> <strong>Operating</strong> <strong>Procedures</strong>• Management of Site <strong>SOP</strong>s– Photocopies• Annual Approval or Change of Site <strong>SOP</strong>s– Annually review and approval by the Research CenterDirector or his delegate– Revision/change to the site <strong>SOP</strong>44
<strong>SOP</strong>-<strong>01</strong>Development, Approval and Review of <strong>Standard</strong> <strong>Operating</strong> <strong>Procedures</strong>Questions ?
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