Cooperative Human Tissue Network Eastern Division

描述（由申请人提供）：本申请的广泛、长期目标是继续参与宾夕法尼亚大学作为合作人体组织网络（CHTN）的东部分部（艾德），该网络通过促进合作努力收集和分发人体生物标本并促进利用这些标本的研究来为公众利益服务。预计这些活动将鼓励在癌症研究的许多领域，包括分子生物学，免疫学和遗传学的基础和发展研究。艾德支持CHTN和科学界的目标将包括：提供大量的、具有良好特征的恶性、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;通过营销努力和患者倡导者的整合，提高对CHTN的认识;与CHTN成员合作进行与组织质量相关的研究和努力;在CHTN协调委员会及其小组委员会任职，以改善网络并受其决定的约束;通过整合的质量管理体系（QMS）确保组织和服务的质量，该体系使当地程序与CHTN操作手册（MOO）保持一致和国家癌症研究所生物标本资源最佳实践（NCIBP），解决从申请到组织处理到运输和计费的每个步骤;提供一个综合信息学计划，将参与CHTN小组的发展活动与分享当地信息学工具和与更广泛的信息学工具相结合，通过与癌症生物医学信息网格（caBIG）的合作和认证，为社区提供基于网络的解决方案，以允许在所有CHTN部门之间共享QC数据和分析QC结果，包括根据caBIG的要求提供应用程序编程接口（API）;并在知情同意不可行的情况下切断与捐赠者的联系，以保护其组织和/或数据可能被利用的患者的权利和隐私。方法将包括组织学和分子质量控制;使用标准操作规程（SOP）;员工培训计划和自愿认证（如可用）;满意度监测;以及使用受控词汇表、通用数据元素和分级权限。这些方法是基于艾德的专业知识honed艾德在20年的参与CHTN告知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.