Liste de Procédures Internationales

Quality Assurance Procedures

• SOP of SOP
• Management of CVs
• Documentation Management
• Audits
• Inspections
• Fraud

Operational Procedures

• Development Plan
• Investigator Brochure
• Clinical Study Synopsis
• Study Protocol and amendments
• Case Report Form
• Clinical Study Quality Plan
• Insurance Certificate
• Ethics Committee
• Standardized Study File
• Ordering Clinical Drugs
• Providing Investigational Centres with Clinical Drugs
• Randomization and Blind Devices
• Selection of Investigators
• Data Protection
• Notification to Health Authorities
• Hospital Directions
• Hospital Pharmacies
• Investigators Meetings
• Set-up Monitoring
• Follow-up Monitoring
• Close-up Monitoring
• Monitoring Clinical Drugs in the Investigational Centres
• Sending back Clinical Drugs
• Selection and management of Contract Reserach Organizations
• Financial Contracts with Investigators
• Serious Adverse Events related to Clinical Trials
• Case Report Forms Flow
• Data entry
• Data management
• Data Blind Review
• Database Freeze
• Statistical Analysis
• Clinical Study Report
• Investigator Documentation

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