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Before the Clinical Phase
One Investigator Brochure and Receipt Forms
2 Signed Protocols and Amendments
5 Financial Agreements and Insurance Statements
6 Agreements between Involved Parties
7 Laboratory Documents
Sample Labels Handling Instructions and Shipment Documentation
9 Certification of Analysis and Decoding Procedures
Ethics Committee and Competent Authority Approvals
4 Cv of New Investigators
5 Laboratory Updates Laboratory Updates
6 Ongoing Product Analysis and Shipment Information
7 Monitoring Visit Reports Monitoring
Eight Communication Influencing Study Conduct
10 Completed Case Report Forms and Safety Reporting Completed
12 Subject Logs and Product Accountability Logs