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JCTO Trial close out process

JCTO Trial close out process. End of Trial as defined in protocol (or last patient, last visit). Early termination of trial. JCTO to send end of trial form to MHRA within required timelines (acknowledgment to be filed on receipt).

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JCTO Trial close out process

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  1. JCTO Trial close out process End of Trial as defined in protocol (or last patient, last visit) Early termination of trial JCTO to send end of trial form to MHRA within required timelines (acknowledgment to be filed on receipt) CI to send end of trial form to EC and R&D within required timelines (acknowledgment to be filed on receipt) CRA to update MATTs Ongoing monitoring activities Monitoring activities complete Book close-out visit • Close out visit • Resolve outstanding queries • Pharmacy visit (final IMP accountability, destruction/ return) • Final TMF and Sponsor file review Site communication and resolution of new or ongoing queries Resolution of critical issues Complete close out checklist and MVR Clinical study report to be sent within 1 year by CI Original Report to be filed in TMF. Copy to be filed in Sponsor File in JCTO and scanned into MATTS. Archiving Related documents; Close out MVR, End of Trial form, Archiving SOP Final v1.0 03/08/2009

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