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中文摘要
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目标 本核心C的目标是制定和实施HIM管理方面的综合培训计划, 为泰国和柬埔寨的卫生专业人员开展临床研究方案。 具体目标 1.建立一个具有成人HIM护理、儿科HIM护理和临床试验实施专业知识的培训师队伍 2.招募和培训新的研究人员、护士和实验室科学家从事临床研究 3.提供临床试验的初始和持续培训,以达到良好临床试验的国际标准 参与本CIPRA计划的研究中心的GCP和GLP 4.为研究中心研究者、护士和实验室工作人员提供项目特定培训 5.建立和维护泰国/柬埔寨CIPRA网站,用于信息传播和交流 6.聘请临床研究助理(CRA) 7.聘请一名护士团队负责人/教育工作者致力于这项CIPRA计划 8.利用现有的高级艾滋病毒-NAT人员作为培训人员 9.制作培训材料 方法 培训师将使用HIM-NAT现有的培训资源和材料,包括GCP、HIM医学、临床试验 行为和实验室技术。这些培训资源将根据CIPRA项目的需要进行调整, 满足两个参与国的需求。该学院将由CIPRA项目协调员Dr 克里斯邓科姆和监督的核心领导人,Theshinee Chuenyam。核心领导人将招募和培训 新的人员,包括一名CRA,他将与CIPRA人员合作开发培训材料并实施 根据研究中心的需要进行GCP/GLP培训。该人员还将监督研究的监查。 现有实验室经理Sasiwimol Ubolyam将监督GLP培训。GCP/GLP和HIM经验 临床管理因研究中心而异。一些研究中心过去进行过临床试验, 如泰国的初级和二级保健医院以及柬埔寨的研究中心,将参与临床研究, 第一次审判。提出了两个单独的综合培训计划,一个针对泰国,另一个针对 柬埔寨.
英文摘要
Objectives The objective of this Core C is to develop and implement comprehensive training programs in HIM management and the conduct of clinical research protocols for health professionals in Thailand and Cambodia. Specific aims 1. to establish a faculty of trainers with expertise in adult HIM care, pediatric HIM care and the conduct of clinical trials 2. to recruit and train new investigators, nurses and laboratory scientists for careers in clinical research 3. to provide initial and ongoing training in the conduct of clinical trials to the international standards of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) for study sites participating in this CIPRA program 4. to provide project-specific training for site investigators, nurses and laboratory staff 5. to establish and maintain a Thailand/Cambodia CIPRA website for information dissemination and exchange 6. to employ a clinical research assistant (CRA) 7. to employ a nurse team leader/educator dedicated to this CIPRA program 8. to utililise existing senior HIV-NAT personnel as trainers 9. to produce training materials Methods The trainers will use existing training resources and material at HIM-NAT which cover GCP, HIM medicine, clinical trial conduct and laboratory techniques. These training resources will be adapted to the needs of the CIPRA projects and to the needs of the two participating countries. The faculty will be directed by the CIPRA Program Co-ordinator, Dr Chris Duncombe and supervised by the Core Leader, Theshinee Chuenyam. The Core Leader will recruit and train new personnel, including a CRA who will work with CIPRA personnel to develop training materials and implement GCP/GLP training according to the needs of the sites. This person will also supervise the monitoring of the studies. The existing laboratory manager, Sasiwimol Ubolyam, will supervise GLP training. Experience in GCP/GLP and HIM clinical management will vary between the sites. Some sites will have conducted clinical trials in the past and some, such as primary and secondary care hospitals in Thailand and the sites in Cambodia, will be participating in clinical trials for the first time. Two separate comprehensive training plans are presented, one for Thailand and one for Cambodia.
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Pediatric HIV Treatment Strategies
Data Management and Statistical Support
Pharmacy Support
Treatment of HIV/Tuberculosis Co-Disease
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