T/CAV 003-2023 Guidelines for the setting up of field visits for clinical research on preventative vaccines

Scope

Main technical content: 1. Basic qualification requirements. 2. Facility layout. 3. Functional zoning and corresponding configurations: setting up reception areas, informed consent rooms, screening number allocation rooms (zones), physical examination rooms (zones), consultation and screening rooms, study number allocation rooms (zones), biological sample collection rooms, vaccination rooms, emergency rooms, medical observation rooms (zones), vaccine storage rooms (warehouses), archives rooms, biological sample processing and storage rooms, supply rooms, case screening laboratories, and temporary storage sites for medical waste, etc. 4. On-site management: including emergency response plans, work systems, and standard operating procedures. 5. Information system configuration

Development Information

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