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Pre-study Phase
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Selection and recruiting of investigators
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Selection of other facilities such as study sites and laboratories
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Pre-study visits and facility check
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Investigator and study participant trainings
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Study initiation visits
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ATCs
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Clinical Part
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Monitoring: regular monitoring visits, reports and actions on on-site problems, recruitment speed, time frame etc.
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Regular telephone contacts with all study participants
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Regular sponsor updates (patient status, recruitment, monitoring activities etc.)
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Study File Management
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Data Query Handling
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Management of investigators and other study participant`s fees
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Logistics (national and multinational) for sample transport, drug and material supply
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Control of drug administration
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Contact to authorities
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Monitor QC
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Data entry
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Control of timelines
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Evaluation Phase
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Quality Control
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Control of timelines
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Statistical analysis
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Final report
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