On-site management of investigational products and drug delivery systems in conformity with Good Clinical Practices (GCPs)
On-site management of investigational products and drug delivery systems in conformity with Good Clinical Practices (GCPs)
复制标题
根据良好临床实践 (GCP) 对研究产品和给药系统进行现场管理
DOI：
10.1177/1740774511431280
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发表时间：
2012
期刊：
影响因子：
2.7
通讯作者：
D. Gaudet
中科院分区：
文献类型：
--
作者：
J. Méthot;D. Brisson;D. Gaudet
背景参与临床试验的研究者和研究团队必须处理复杂的研究产品、研究设计和研究环境。新的药物输送系统和研究产品的出现结合了一种以上的药物和生物药物的发展，如单克隆抗体，肽，siRNA和基因治疗，以治疗孤儿或常见疾病构成了一个新的挑战，研究人员和临床研究中心。目的我们描述了药物管理的要求和挑战，符合良好的临床实践（GCP）的研究者和参与临床试验的网站。审查在所有参与临床试验的研究中心，都需要涵盖药物和药物输送系统管理关键路径的标准操作规程（SOP）。所有步骤都应可审计，包括研究产品的接收、验证、储存、获取、制备、分发、管理技术、使用、返还和销毁。生物药物需要可追溯性和管理潜在免疫反应的具体SOP。试验用药品必须在标准可稽查条件下储存。储存条件（包括温度）的可追溯性要求持续监测这些条件。专用空间（仅限授权合格人员进入）便于监测。结论制定标准化的、可审核的环境，并应用专门的、针对研究中心的SOP来管理试验用产品和给药系统，有助于保证符合GCP要求。
Background Investigators and research teams participating in clinical trials have to deal with complex investigational products, study designs, and research environments. The emergence of new drug delivery systems and investigational products combining more than one drug and the development of biodrugs such as monoclonal antibodies, peptides, siRNA, and gene therapy to treat orphan or common diseases constitute a new challenge for investigators and clinical sites. Purpose We describe the requirements and challenges of drug management in conformity with Good Clinical Practices (GCPs) for investigators and sites participating in clinical trials. Review At all sites participating in clinical trials, standard operating procedures (SOPs) covering the critical path of drug and drug delivery systems management are required. All steps should be auditable, including reception, validation, storage, access, preparation, distribution, techniques of administration, use, return, and destruction of research products. Biodrugs require traceability and specific SOPs on the management of potential immune reactions. Investigational products must be stored under standard auditable conditions. The traceability of storage conditions (including temperature) requires these conditions to be monitored on a continuous basis. A dedicated space with restricted access limited to authorized qualified personnel facilitates the monitoring. Conclusions The development of standardized, auditable settings and the application of dedicated, site-specific SOPs for the management of investigational products and drug delivery systems contribute to guarantee the compliance to GCP requirements.