Cooperative Human Tissue Network Eastern Division

描述(由申请人提供)：这项申请的广泛、长期目标是继续让宾夕法尼亚大学作为合作人体组织网络(CHTN)的东部分部(ED)参与，该组织通过鼓励合作努力收集和分发人类生物标本来服务于公共利益，并促进利用这些标本的研究。这些活动预计将鼓励在许多癌症研究领域进行基础和发展研究，包括分子生物学、免疫学和遗传学。教育署支持该中心和科学界的目标将包括提供大量和多样化的符合研究人员规格的具有良好特征的恶性、正常和良性人体组织样本；通过营销努力和患者权益倡导者的整合提高对该组织的认识；与该中心的成员合作进行与组织质量有关的研究和努力；为该中心协调委员会及其小组委员会服务，以改善网络并受其决定的约束；通过综合质量管理系统(QMS)确保组织和服务的质量，该系统将当地程序与CHTN操作手册(MOO)和国家癌症研究所生物样品资源最佳做法(NCIBP)协调起来，处理从应用程序接收到组织加工到发货和计费的每个步骤；提供综合信息学计划，将参与CHTN小组发展活动与共享当地信息学工具相结合，并通过与癌症生物医学信息网格(CaBIG)的合作和认证与更广泛的社区整合；提供基于网络的解决方案，以便在CHTN的所有部门之间共享QC数据和分析QC结果，包括按照caBIG的要求提供应用程序编程接口(API)；并保护患者的权利和隐私，在知情同意不可行的情况下，通过切断与捐赠者的链接来利用患者的组织和/或数据。方法将包括组织和分子质量控制；使用标准操作程序(SOP)；工作人员培训计划和可用的自愿认证；满意度监测；以及受控词汇、公共数据元素和分级权限的使用。这些方法的基础是教育部门在参与CHTN的20年中磨练出的专门知识，并了解了最新的最佳做法和行业标准。

DESCRIPTION (provided by applicant): The broad, long-term objective of this application is to continue the participation of the University of Pennsylvania as the Eastern Division (ED) of the Cooperative Human Tissue Network (CHTN), which serves the public good by stimulating cooperative efforts to collect and distribute human biospecimens and to facilitate research utilizing those specimens. These activities are expected to encourage basic and developmental studies in many areas of cancer research, including molecular biology, immunology and genetics. The ED's aims in support of the CHTN and the scientific community will include providing high volumes and diversities of well-characterized malignant, normal, and benign human tissue samples prepared to investigator specifications; increasing awareness of the CHTN through marketing efforts and integration of patient advocates; working with CHTN members on studies and efforts related to tissue quality; serving on the CHTN Coordinating Committee and its subcommittees to improve the network and be bound by its decisions; ensuring quality of tissue and services through an integrated Quality Management System (QMS) that harmonizes local procedures with the CHTN Manual of Operations (MOO) and National Cancer Institute Best Practices for Biospecimen Resources (NCIBP), addressing each step of the process from application intake to tissue processing to shipment and billing; offering an integrated informatics program that combines participation in CHTN group development activities with sharing of local informatics tools and integration with the broader community through cooperation and certification with the cancer Biomedical Informatics Grid (caBIG); to provide a web-based solution to allow sharing of QC data and analysis of QC results among all CHTN divisions, including the provision of application programming interfaces (API's) as required by caBIG; and to protect the rights and privacy of patients whose tissue and/or data may be utilized by severing links to the donor in cases for which informed consent is not practicable. Methods will include histological and molecular quality control; use of standard operating procedures (SOP's); staff training programs and voluntary certifications as available; satisfaction monitoring; and use of controlled vocabularies, common data elements, and hierarchical permissions. These approaches are based on ED expertise honed in 20 years of participation in the CHTN informed by the latest best practices and industry standards.