SITE MANAGEMENT ORGANIZATION​​

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Feasibility Activities and Site Selection:
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Study and Research Planning on Patient Population
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Qualification Visit
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Planning Functions and Responsibilities
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Communication Documentation
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Investigator Recruitment:
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Investigator Meeting Organizations
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Meeting Location Selection and Organization
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Institution & Investigator Fee Payments Organization
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Patient Recruitment:
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Subject Recruitment Retention
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Travel Organization for Participants
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Preparation of Meeting and Training Materials
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Subject Data Protection
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Materials Management
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Source Documentation​
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Site Initiation, Monitoring, and Close-Out Activities:
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Site Staff Training, Including Electronic Data Capture (EDC)
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Safety Reporting
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Informed Consent Form
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Study Drug Device Management
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Subject Visit Management
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Onsite Study File Management
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Pharmacovigilance
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Unblinding Process
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Case Report Form Completion
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Study Closure and Document Archiving
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Audits & Inspections
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