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首页> 美国卫生研究院文献>Biopreservation and Biobanking >The Establishment of an ISO Compliant Cancer Biobank for Jordan and its Neighboring Countries Through Knowledge Transfer and Training
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The Establishment of an ISO Compliant Cancer Biobank for Jordan and its Neighboring Countries Through Knowledge Transfer and Training

机译：通过知识转移和培训为约旦及其邻国建立符合ISO标准的癌症生物库

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Research studies aimed at advancing cancer prevention, diagnosis, and treatment depend on a number of key resources, including a ready supply of high-quality annotated biospecimens from diverse ethnic populations that can be used to test new drugs, assess the validity of prognostic biomarkers, and develop tailor-made therapies. In November 2011, KHCCBIO was established at the King Hussein Cancer Center (KHCC) with the support of Seventh Framework Programme (FP7) funding from the European Union (khccbio.khcc.jo). KHCCBIO was developed for the purpose of achieving an ISO accredited cancer biobank through the collection, processing, and preservation of high-quality, clinically annotated biospecimens from consenting cancer patients, making it the first cancer biobank of its kind in Jordan. The establishment of a state-of-the-art, standardized biospecimen repository of matched normal and lung tumor tissue, in addition to blood components such as serum, plasma, and white blood cells, was achieved through the support and experience of its European partners, Trinity College Dublin, Biostór Ireland, and accelopment AG. To date, KHCCBIO along with its partners, have worked closely in establishing an ISO Quality Management System (QMS) under which the biobank will operate. A Quality Policy Manual, Validation, and Training plan have been developed in addition to the development of standard operating procedures (SOPs) for consenting policies on ethical issues, data privacy, confidentiality, and biobanking bylaws. SOPs have also been drafted according to best international practices and implemented for the donation, procurement, processing, testing, preservation, storage, and distribution of tissues and blood samples from lung cancer patients, which will form the basis for the procurement of other cancer types. KHCCBIO will be the first ISO accredited cancer biobank from a diverse ethnic Middle Eastern and North African population. It will provide a unique and valuable resource of high-quality human biospecimens and anonymized clinicopathological data to the cancer research communities world-wide.
机译：旨在促进癌症预防，诊断和治疗的研究取决于许多关键资源，包括现成的，来自不同种族人群的高质量带注释生物标本，这些标本可以用于测试新药，评估预后生物标志物的有效性，并开发量身定制的疗法。 2011年11月，在欧盟第七框架计划（FP7）的资助（khccbio.khcc.jo）的支持下，侯赛因国王癌症中心（KHCC）成立了KHCCBIO。开发KHCCBIO的目的是，通过收集，加工和保存同意的癌症患者的高质量，带有临床注释的生物标本，从而获得ISO认可的癌症生物库，使其成为约旦首个此类癌症生物库。通过其欧洲合作伙伴的支持和经验，除了血液成分（例如血清，血浆和白血球）外，还建立了匹配的正常和肺肿瘤组织的最新，标准化的生物样本库，都柏林三一学院，爱尔兰Biostór和accelopment AG。迄今为止，KHCCBIO及其合作伙伴已经在建立ISO质量管理体系（QMS）方面进行了密切合作，该生物库将在该质量管理体系下运行。除了制定标准操作程序（SOP）以外，还制定了质量政策手册，验证和培训计划，以就道德问题，数据隐私，机密性和生物银行章程达成一致。还根据国际最佳实践起草了标准操作程序，并用于捐赠，采购，加工，测试，保存，存储和分配肺癌患者的组织和血液样本，这将成为采购其他类型癌症的基础。 KHCCBIO将成为中东和北非不同种族中首家获得ISO认证的癌症生物库。它将为全世界的癌症研究社区提供高质量的人类生物标本和匿名临床病理数据的独特而宝贵的资源。

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