药物临床试验用药品管理山东专家共识

doi:10.6040/j.issn.1671-7554.0.2025.1094

摘要/Abstract

摘要： 试验用药品指用于临床试验的试验药物与对照药品,其安全性和有效性尚未得到充分验证。若管理不当,不仅可能直接危害受试者安全,也可能影响试验数据的真实性和可靠性。目前,山东省内各临床试验机构在试验用药品的管理流程、温控合规性及责任界定等方面存在差异,亟需建立统一、规范的管理标准。为此,山东省药学会组织相关领域专家,依据国家《药物临床试验质量管理规范》法规要求,结合本省实践,制定了本共识。经过两轮专家研讨论证,共识以96.77%的赞同率获得通过。内容涵盖试验用药品管理的职责分工与全流程操作规范,旨在为省内各临床试验机构提供科学、可行的标准化指引,进一步提升全省药物临床试验的质量与安全管理水平。

关键词: 药物临床试验, 试验用药品管理, 山东共识, 全流程管理, 职责分工

Abstract: “Investigational medicinal products” refer to drugs used in clinical trials, including experimental drugs and control drugs, the safety and effectiveness of which have not been fully verified. Improper management of these drugs may not only directly endanger the safety of subjects, but also affect the authenticity and reliability of test data. At present, there are differences in the management process, temperature control compliance and responsibility determination of the test drugs among the clinical trial institutions in Shandong Province, and there is an urgent need to establish unified and standardized management standards. In this regard, the Shandong Pharmaceutical Association has organized experts in related fields and formulated this consensus based on the requirements of the national “Good Clinical Practice for Drug Clinical Trials” and the practice of the province. After two rounds of expert discussion and demonstration, the consensus was passed with a 97% approval rate. The content covers the division of responsibilities and the whole process operation specification of the management of the test drugs, aiming to provide scientific and feasible standardization guidance for the clinical trial institutions in the province, and further improve the quality and safety management level of the drug clinical trials in the whole province.

Key words: Drug clinical trials, Investigational medicinal products management, Shandong consensus, End-to-end management, Delineation of roles and responsibilities

中图分类号:

R954

山东省药学会. 药物临床试验用药品管理山东专家共识[J]. 山东大学学报 (医学版), 2026, 64(4): 8-13.

Shandong Pharmaceutical Association. Shandong Provincial expert consensus on investigational product management in drug clinical trials[J]. Journal of Shandong University (Health Sciences), 2026, 64(4): 8-13.

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