Investigator Meeting January 2010 Protocol Review and Refresher

Study close out Supplies Data EFIC Regulatory

Study close out - supplies Destroy Remaining Study Drug –Remove all study boxes from field –Waste and retire study drug in WebDCU Remaining Supplies –Return study boxes to CCC –Return SD cards to CCC

Study close out - data DCR Completion –Review all open DCRs –Update per request, save, and re-submit

Study close out - EFIC Public Disclosure Activities –Contact local IRB to determine if study close out can occur prior to completion of PD –Complete all remaining PD activities

Study close out - regulatory Study Termination Report –Submit to IRB –Upload Termination Report in WebDCU along with documentation of IRB acknowledgment of study close-out Document Retention –Study documents should be retained for a minimum period of 6 years

Study close out – monitoring visit Purpose is to ensure that… –all data have been collected, recorded, and submitted –all records are complete, accurate, and filed properly –all investigational product is accounted for –any unused product and supplies are returned or destroyed as appropriate –all outstanding issues are resolved –all guidelines and regulations have been followed