Polaris

SOP# IRB-004.0CompanyEffective Date: DD/MMM/YYIII.ProceduresA. ResponsibilityThe IRB files will be maintained by the IRB Secretary at .B. IdentificationIRB records will include the following:1. IRB members’ recordsa. Curriculum vitae for each board memberb. Training records for each IRB memberc. Documentation of training sessions attended by board members, includingsigned attendance sheets and a copy of the handouts and slidesd. Documentation of resignation/termination2. IRB membership roster3. IRB meeting minutes4. Materials provided to board members for review (including, but not limited to,investigator brochures, protocols, amendments, consent forms, IND SafetyReports, progress reports)5. Correspondence with the Investigators6. Documentation of expedited review and approval7. Statements of new findings provided to subjects8. Standard Operating ProceduresC. Retention and AccessibilityAll IRB records will be retained for at least three (3) years after the completion of theresearch.IRB records will be made available for inspection and copying by authorizedrepresentatives of DHHS, FDA, and other regulatory authorities after receiving therequest in writing.D. IRB Minutes1. The minutes of the IRB meetings will be in sufficient detail to show the followingfor each research protocol:a. Attendance at the meetingb. A summary of the discussion and the resolution of controversial issuesc. Actions taken by the boardIRB-004.0.doc© 2004 by CRC Press LLC