Step 5: Regulatory Review Locate, compile, organize, and review the documents listed below for accuracy and completeness. Please contact the JCTO Quality Assurance Unit if you have any questions regarding the documents listed below (). Document Confirm/Complete Comments/Action Principal Investigator CV (including list of all ___ Yes ___ No ___N/A active protocols) Principal Investigator Medical License ___ Yes ___ No ___N/A Principal Investigator Good Clinical Practice/Human Subjects Protection ___ Yes ___ No ___N/A Training Documentation Principal Investigator Financial Disclosure ___ Yes ___ No ___N/A Form Sub-Investigator(s) CV (including list of all ___ Yes ___ No ___N/A active protocols) Sub-Investigator(s) Medical License ___ Yes ___ No ___N/A Sub-Investigator(s) Good Clinical Practice/Human Subjects Protection ___ Yes ___ No ___N/A Training Documentation Sub-Investigator(s) Financial Disclosure ___ Yes ___ No ___N/A Form Study Staff CVs ___ Yes ___ No ___N/A Study Staff Relevant Licensure ___ Yes ___ No ___N/A Study Staff Good Clinical Practice/Human ___ Yes ___ No ___N/A Subjects Protection Training Documentation Study Staff Financial Disclosure Forms ___ Yes ___ No ___N/A Study Staff Protocol Training Log(s) ___ Yes ___ No ___N/A
Step 5: Regulatory Review Locate, compile, organize, and review the documents listed below for accuracy and completeness. Please contact the JCTO Quality Assurance Unit if you have any questions regarding the documents listed below (). Document Confirm/Complete Comments/Action Principal Investigator CV (including list of all active protocols) ___ Yes ___ No ___N/A Principal Investigator Medical License ___ Yes ___ No ___N/A Principal Investigator Good Clinical Practice/Human Subjects Protection Training Documentation ___ Yes ___ No ___N/A Principal Investigator Financial Disclosure Form ___ Yes ___ No ___N/A Sub-Investigator(s) CV (including list of all active protocols) ___ Yes ___ No ___N/A Sub-Investigator(s) Medical License ___ Yes ___ No ___N/A Sub-Investigator(s) Good Clinical Practice/Human Subjects Protection Training Documentation ___ Yes ___ No ___N/A Sub-Investigator(s) Financial Disclosure Form ___ Yes ___ No ___N/A Study Staff CVs ___ Yes ___ No ___N/A Study Staff Relevant Licensure ___ Yes ___ No ___N/A Study Staff Good Clinical Practice/Human Subjects Protection Training Documentation ___ Yes ___ No ___N/A Study Staff Financial Disclosure Forms ___ Yes ___ No ___N/A Study Staff Protocol Training Log(s) ___ Yes ___ No ___N/A
step_by_step_guide_to_preparing_for_fda_inspections.docx