International project management
Central management of large international studies
Major activities of International Project Management are:
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Briefing of national study units
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Feasibility questionnaires
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Production of documentation-material and logistics
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CRF handling instructions, annotated CRFs, trial guidelines, project-specific SOPs
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Interaction of third parties (central laboratories, randomization centers, logistic centers, local CROs)
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Kick-off meetings and training of national staff
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Documentation lists and tracking tools
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Check of milestones and deadlines
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Regular telephone conferences
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Conference minutes, newsletters and reports on study status, study-material logistics
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Early warning concept and risk management
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Query management
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Process optimization
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Logistics of interim analyses
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Science-review logistics
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Essential-study documents logistics
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Support of national units during study site close-down
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Management of trial master file
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Support of national units with audits and inspections