T/CGCPU 014-2020 The management specifications for clinical trial chemical drugs within clinical trial institutions

Scope

Scope: This standard specifies the operational and management norms for the internal circulation of clinical trial drugs in clinical trial institutions. This standard applies to pharmaceutical manufacturers, enterprises with logistics qualifications for clinical trial drugs, and clinical trial institutions participating in drug clinical trials in China. The standard stipulates the operational norms for multiple links in the internal circulation chain of clinical trial drugs in clinical trial institutions, including the receipt, storage, distribution, recovery, return, recall, and destruction of clinical trial drugs, as well as the information recording of clinical trial drugs. Pharmaceutical companies and medical institutions participating in drug clinical trials may refer to and implement it accordingly. If there are inconsistencies between the content of this standard and the competent authorities, or if new regulations are issued by the higher-level competent authorities, the provisions of the higher-level competent authorities shall prevail. Main technical content: 1. Scope 2. Normative reference documents 3. Terms and definitions 3.1 Investigational product 3.2 Comparator product 3.3 Quality assurance 3.4 Quality control 3.5 Inner packing 3.6 Outer packing 4. Supply of clinical trial drugs 5. Storage of clinical trial drugs in clinical trial institutions 5.1 Spatial conditions 5.2 Hardware equipment and facilities 5.3 Personnel requirements and qualifications 5.4 Management and inventory replenishment of investigational products 5.5 Other requirements 6. Distribution of clinical trial drugs 7. Use of clinical trial drugs 8. Recovery of clinical trial drugs 9. Return of clinical trial drugs 10. Recall of clinical trial drugs 11. Destruction of clinical trial drugs 12. Information recording of clinical trial drugs

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