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Investigator Meeting January 2010

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

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Investigator Meeting January 2010

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  1. Investigator MeetingJanuary 2010 Protocol Review and Refresher

  2. Study close out • Supplies • Data • EFIC • Regulatory

  3. 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

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

  5. 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

  6. 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

  7. 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

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