Inspection and evaluation conditions, scoring standards and result evaluation; On-site inspection content and evaluation standards for centralized management of clinical investigational drugs: 1. Space conditions 2. Hardware equipment and facilities 3. Personnel requirements and qualifications 4. Management system and standard operating procedures 5. Research drug management process and general requirements 6. Drug record and file management 7. Management of special drugs 8. Management information system research drug satellite pharmacy management;
T/CGCPU 002-2016 history
2023T/CGCPU 002-2023 Evaluation standard of centralized management of clinical investigational product
2016T/CGCPU 002-2016 The standard of on-site inspection for clinical investigational drug centralized management