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中文摘要
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目标 核心A的目的是提供额外的药房设施,使药物供应和分销得以顺利进行。 根据药物临床试验质量管理规范(GCP)的要求,为CIPRA项目中的所有项目提供药物。 具体目标 1、聘请一名全职的、合格的药剂师和一名药房助理,在艾滋病毒-NAT工作,并监督 所有项目地点的药房活动 2.使用现有的NIH批准的药物管理计划 3.扩大药房容量和储存设施,包括适当的药物标签区 4.为药物储存提供气候控制 5.使用需要在受控室温(< 30摄氏度)下储存的抗逆转录病毒药物 6.为HIV-NAT的药房提供备用发电机 7.提供计算机和“Office”软件,用于药物供应的会计 8.管理向项目地点分发药物 方法 这将通过雇用一名全职的合格药剂师和扩大药房储存和工作来实现 新装修的约70平方米的房间,包括一个适当的药物标签区, 符合GCP。新药房将配备温控空调(24小时)和 备用发电机配备数据库软件的专用计算机将有助于适当的库存控制, 药品问责制和传真将使供应商和远程项目现场的有效沟通。新 将在所有研究中心提供文件和药物储存。
英文摘要
Objectives The objective of this Core A is to provide additional pharmacy facilities to enable the smooth supply and distribution of drugs for all projects in this CIPRA program in accordance with the requirements of Good Clinical Practice (GCP). Specific aims 1, to employ a full-time, qualified pharmacist and a pharmacy assistant to be located at HIV-NAT and to supervise pharmacy activity at all project sites 2. to employ an existing NIH approved drug management plan 3. to expand pharmacy capacity and storage facilities, including an appropriate area for drug labelling 4. to provide climate control for drug storage 5. to use antiretroviral drugs which require storage at controlled room temperature (< 30 deg C) 6. to provide a back-up power generator for the pharmacy at HIV-NAT 7. to provide a computer and 'Office' software for accounting of pharmaceutical supplies 8. to manage the distribution of drug to project sites Methods This will be achieved by employing a full-time, qualified pharmacist and by expanding pharmacy storage and working areas into a newly refurbished room of approximately 70 m 2, including an appropriate area for drug labelling in accordance with GCP. The new pharmacy will be supplied with temperature-controlled air-conditioning (24-hours) and a back-up power generator. A dedicated computer with database software will facilitate proper stock control and accountability of drugs and a facsimile will enable efficient communication with suppliers and remote project sites. New document and drug storage will be provided at all sites.
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Pediatric HIV Treatment Strategies
Data Management and Statistical Support
Training Support
Treatment of HIV/Tuberculosis Co-Disease
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