Biomedical Research Support Shared Resource

PROJECT SUMMARY – BIOMEDICAL RESEARCH SUPPORT SHARED RESOURCE New Cancer Center Support Grant Shared Resource The Biomedical Research Support Shared Resource (BRSSR) enables Cancer Center members to perform human subject research in the context of partnerships between Wistar investigators and clinical care providers. Introduced as a developmental core at the 2013 Cancer Center Support Grant (CCSG) renewal, the BRSSR has been launched as a full-service Cancer Center Shared Resource during the last CCSG budget cycle. By providing a centralized resource for human subject-based research at Wistar, the BRSSR makes available to Cancer Center investigators a comprehensive menu of services to (i) coordinate the procurement of human subject-derived biospecimens from clinical partners, volunteers (phlebotomy service) or commercial partners; (ii) provide expertise in fulfilling research compliance with ethical and regulatory mandates; (iii) assist investigators to ensure that biospecimen and data collection is conducted in compliance with Good Clinical Practice (GCP), regulatory mandates (e.g. 21 CFR Part 11, HIPAA etc.) and contractual obligations; (iv) provide access to tissue processing and advanced histotechnology techniques for specimens analysis; and (v) provide low-cost, customized solutions for centralized data storage and management that ensure the consistency, completeness and quality of the data received from clinical providers. Our collaborative partnership with the Helen F. Graham Cancer Center (HFGCC) at Christiana Care Health System (CCHS), a member Institution of the National Community Cancer Center Program (NCCCP), provides Wistar Cancer Center members with access to fresh biospecimens, including fine-needle aspirate, biopsies, surgical resections, and biological fluids from cancer patients, instrumental to fulfill the mission of the Cancer Center in translational and patient-focused cancer research. Substantial institutional investments have been made to develop and validate an electronic data management platform, CDETweb® Toolbox, to manage human subject data in the BRSSR. As fully deployed, the CDETweb® platform is customizable to meet specific data collection and sample tracking needs, supporting multiple data entry modes (e.g. keying and direct uploads), randomization, asymmetrical visit schedules, screening and entry criteria gatekeeping, and other custom-defined requirements. BRSSR services also support a phlebotomy service (protocol management, donor management, testing, etc.) and access to tissue microarray services (array design and customization, ordering and tracking). As a result, the BRSSR provides a robust infrastructure to support mechanistic, patient-oriented research by managing all aspects of procurement of human subject-derived biospecimens.