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Minimum Biobanking Requirements:Issues in a Comprehensive Cancer Center Biobank

机译:最低生物库要求:综合癌症中心生物库中的问题

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摘要

Cancer biobanks, when located within a comprehensive cancer center, are characterized by management and organizational peculiarities mainly related to the multidisciplinary information available of such specialized centers and the continuous collection stream of quality-assessed biospecimens. The present study summarizes the main characteristics of comprehensive cancer center biobanks and, more in detail, procedures addressed in order to maintain full control over interlacement issues that occur at every level, from patient enrolment eligibility and consenting to dissemination and utilization of specimens and associated data. Dedicated personnel, appropriate storage facilities, as well as ethical, legal, and technical requirements are among the most relevant aspects strongly conditioning the quality of these structures. Because of its location and the need to be directly connected with clinical units, such as pathology, oncology, surgery, etc., ad hoc information technology tools are crucial to support all aspects of biorepository operations, including (but not limited to) patient enrolment and consent; biospecimen collection, processing, storage, and distribution; quality assurance and quality control; collection of patient data; validation documentation; and management reporting functions.
机译:癌症生物库位于综合癌症中心内时,其特点是管理和组织方面的特点,主要与此类专业中心的多学科信息以及质量评估的生物标本的连续收集流有关。本研究总结了综合癌症中心生物库的主要特征,并更详细地介绍了解决程序,以保持对从患者入选资格和同意到标本的传播和利用以及相关数据的各个层面发生的隔行扫描问题的完全控制。最相关的方面包括专门的人员,适当的存储设施以及道德,法律和技术要求,这些条件在很大程度上决定着这些结构的质量。由于其位置以及与病理学,肿瘤学,手术等临床部门直接联系的需要,临时信息技术工具对于支持生物存储库操作的各个方面(包括(但不限于)患者入组)至关重要和同意;生物样本的收集,加工,存储和分配;质量保证和质量控制;收集患者数据;确认文件;和管理报告功能。

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