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.
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