Cooperative Human Tissue Network Eastern Division

描述（由申请人提供）：本申请的广泛、长期目标是继续宾夕法尼亚大学作为合作人体组织网络（CHTN）东部分部（ED）的参与，通过促进合作努力收集和分发人类生物标本，并促进利用这些标本的研究，为公共利益服务。预计这些活动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。为支持CHTN和科学界，ED的目标将包括提供大量和多样化的特征明确的恶性、正常和良性人体组织样本，这些样本是按照研究者的规格制备的；通过营销努力和整合患者倡导者，提高对CHTN的认识；与CHTN成员合作开展与组织质量有关的研究和工作；在中国卫生网络协调委员会及其小组委员会任职，以改善该网络，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，该系统与CHTN操作手册（MOO）和国家癌症研究所生物标本资源最佳实践（NCIBP）的本地程序相协调，解决从申请到组织处理到运输和计费的每个步骤；提供综合信息学计划，将参与CHTN集团发展活动与分享当地信息学工具结合起来，并通过与癌症生物医学信息学网格（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所有部门之间共享质量控制数据和分析质量控制结果，包括按caBIG要求提供应用程序编程接口（API）；在无法获得知情同意的情况下，通过切断与捐赠者的联系，保护患者的组织和/或数据可能被利用的权利和隐私。方法包括组织学和分子质量控制；使用标准操作程序（SOP）；提供员工培训计划和自愿认证；满意度监测;以及使用受控词汇表、公共数据元素和分层权限。这些方法是基于ED在20年参与CHTN过程中积累的专业知识，并结合最新的最佳实践和行业标准。

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.