Establishment of an H3Africa Biorepository at Contract Laboratory Services

在合同实验室服务处建立 H3Africa 生物样本库

• 批准号: 9335980
• 负责人: Elizabeth Mayne
• 金额: $ 59.7万
• 依托单位: WITS HEALTH CONSORTIUM (PTY), LTD
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-25 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9335980
• 关键词: AIDS clinical trial group; AIDS prevention; Accreditation; Achievement; Address; Adopted; Adult; Africa; African; Air; Bioinformatics; British; Caring; Certification; Clinical Distribution; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Communicable Diseases; Communities; Computer Hardware; Computer software; Contracts; Country; Database Management Systems; Developing Countries; Development; Diagnostic; Diagnostics Research; Disease; Ensure; Environment; Evaluation; Feasibility Studies; Freezing; Funding; Genetic Research; Genomics; Goals; HIV vaccine; Health; Household; Human; Human Resources; IMPAACT; Immunology; Individual; International; Knowledge; Label; Laboratories; Laboratory Research; Link; Liquid substance; Malignant Neoplasms; Medical Research; Microbicide Trials Network; Mission; Monitor; Nitrogen; Phase; Prevalence Study; Prevention; Process; Proteomics; Recording of previous events; Reporting; Research; Research Infrastructure; Research Project Grants; Research Support; Retrieval; Robotics; Safety; Sampling; Scientist; Secure; Services; Site; South Africa; South African; Specific qualifier value; System; Technology; Training; Training Support; United States; United States National Institutes of Health; Universities; Vaccine Clinical Trial; Wit; Work; base; biobank; clinical practice; cost efficient; data management; data sharing; epidemiology study; experience; high standard; improved; operation; pediatric AIDS; public health relevance; quality assurance; radio frequency; repository; research study; tool; trend analysis

DESCRIPTION (provided by applicant): This H3Africa biorepository project covers the extension and improvement of the biorepository capacity at the Contract Laboratory Services (CLS), which is subsidiary of the University of the Witwatersrand. Established in 2000, CLS is a focused organization providing diagnostic laboratory services, including sample storage facilities for clinical trials and research studies. It already manages a large repository (>700,000 samples) of human samples on behalf of a number of collaborating clinical trial networks including NIH funded CIPRA project "Safeguard the household" (2002-2008), Central HIV Aids Vaccine Immunology (CHAVI), the International HIV/AIDS Vaccine Initiative (IAVI), the Adult and Pediatric AIDS Clinical Trials Group (ACTG/PACTG/IMPAACT), Partners in Prevention (PIP and PreP), Microbicide Trial Network (MTN), and acts as the central repository for the South African Cancer Epidemiological Research Group. Due to our experience in clinical trials and laboratory support work in Africa, we value capacity building in this environment to address and support health needs as critical. In order to be a key stakeholder in the H3Africa mission, the project funding will be used to expand and optimize CLS' sample storage infrastructure in order to accommodate samples from H3Africa in a dedicated state of the art facility. The project will also assist with the implementation of several important CLS activities in order to better serve the needs of the H3Africa initiative, including the upgrading of its laboratory and sample management software, the use of radio frequency identification tags to reduce human error and sample degradation, and the further training of its staff in quality assurance, and repository management tools and standards. In the first phase of the project (UH2), CLS will undertake a more detailed assessment and feasibility analysis of trends in biorepository technology and the needs of H3Africa, particularly in respect of sample tracking, analysis, storage, retrieval and distribution. It will also use this period to build further links with all the H3Africa /genomic research centers in order to align CLS biorepository capacity building with the needs of our collaborators and prepare detailed specifications for the second phase (UH3) activities. In the second phase (UH3), CLS will activate a dedicated H3Africa biorepository, collecting, storing and distributing samples from and to all over Africa as specified in the scoping studies of UH2. It will also implement several state-of-the-art repository practices in order to ensure the highest care and management of H3Africa samples. In all stages specific care will be taken to maintain the high standards of sample protection, as required by CLS' clinical trial partners. We note that CLS already has the following achievements in this regard: "ISO 15189 accreditation for all its laboratories (and excellent inspection reports) through the South African National Accreditation System (SANAS) since 1999" accreditation for the CLS laboratory through the British Quality Group "DAIDS approved through PPD and FHI monitoring" IATA and LDMS certification of its repository. CLS has a proven track history of managing and growing its biorepository over the last 10 years in a highly cost-efficient manner; this project will further support expansion and continuous improvement of these services.

描述（由申请人提供）：该H3AFRICA生物座项目项目涵盖了合同实验室服务（CLS）的生物座位能力的扩展和改善，该公司是Witwatersrand大学的子公司。 CLS成立于2000年，是一个专注的组织，提供诊断实验室服务，包括用于临床试验和研究的样本存储设施。它已经代表许多合作的临床试验网络管理了大量的人类样本（> 700,000个样本）样本，包括NIH资助的CIPRA项目“保障家庭”（2002-2008）（2002-2008），中央HIV HIV AIDS艾滋病疫苗疫苗疫苗免疫学（CHAVI），国际艾滋病毒/艾滋病毒/艾滋病疫苗临床临床（IAVI），成人和PEDIACIAN，IAVI和PEDIACIAICIAN，IAVI和PEDIACIAD） （ACTG/PACTG/INCACT），预防（PIP和PREP），菌心试验网络（MTN）的合作伙伴，并充当南非癌症流行病学研究小组的中央存储库。由于我们在非洲的临床试验和实验室支持工作方面的经验，我们在这种环境中重视能力建设，以满足和支持健康需求至关重要。为了成为H3africa任务的关键利益相关者，该项目资金将用于扩展和优化CLS的样本存储基础架构，以便在专用状态的H3africa中容纳H3africa的样本。该项目还将有助于实施几项重要的CLS活动，以更好地满足H3africa计划的需求，包括升级其实验室和样本管理软件，使用射频识别标签来减少人体错误和样本降级，以及对员工在质量保证方面的进一步培训，以及质量保证，以及重新库的工具和标准。 在项目的第一阶段（UH2）中，CLS将对生物座位技术的趋势和H3africa的需求进行更详细的评估和可行性分析，尤其是在样本跟踪，分析，存储，存储，检索和分布方面。它还将利用这一时期与所有H3AFRICA /基因组研究中心建立进一步的联系，以使CLS BiorePository的能力构建与我们的合作者的需求保持一致，并为第二阶段（UH3）活动准备详细的规格。在第二阶段（UH3）中，CLS将激活专用的H3africa生物座席，按照UH2的范围研究中指定的从非洲收集，存储和分发样品。它 还将实施几种最先进的存储库实践，以确保对H3africa样本的最高护理和管理。根据CLS的临床试验伙伴的要求，将在所有阶段进行特定的护理以保持样本保护的高标准。我们注意到，CLS在这方面已经取得了以下成就：“ ISO 15189自1999年以来通过南非国家认证系统（SANAS）对其所有实验室（以及出色的检查报告）的认证”“通过PPD和FHI Monitoring“ IATA和FHI Monitoring”重复证明了CLS实验室的认证。 CLS在过去10年中以高度成本效益的方式管理和发展其生物座席的历史有了悠久的历史；该项目将进一步支持这些服务的扩展和持续改进。