1. The IndianaCTSI Biorepository is committed to serving the repository needs for CTSI investigators. The core will tailor specimen management to the needs of each investigator. Whenever possible, it will facilitate broad use specimen distribution and data sharing. Support is provided through the CTSI to minimize use fees, insure sample integrity and security, and promote compliance with national and international standards. The IndianaCTSI Biorepository supports collection, processing, storage and distribution of biologic specimens and associated data for investigators throughout Indiana: Protocol specific specimen collection packet preparation Protocol specific sample processing Sample storage (Investigator directed or broad use) CaTissue sample management and distribution CaTissue protocol management Consultation for sample collection, processing and storage Coordination with the National Virtual Biorepository Lilith Reeves Chief Scientific Officer, IndianaCTSI 317-278-6930 lreeves@iupui.edu George E. Sandusky, Jr., D.V.M., Ph.D. Associate Director, IU Simon Cancer Center Tissue Procurement & Distribution 317-278-2304 gsandusk@iupui.edu The IndianaCTSI Biorepository is committed to assuring sample quality, integrity and management via: Formal Quality Management Plan Comprehensive oversight committee SOP driven practices Sample Quality Control SOP driven practices Committed QA oversight Storage facility with continual dual alarming system and back-up storage capacity Samples are to be processed and stored in a newly constructed biorepository facility funded in part through an NCRR/NCI construction grant and operated by the IndianaCTSI. Key facility systems include an electronic card access system, back-up power and continual monitoring of freezer equipment through both a direct alarm line to central facilities and a separate dial-out system to facility personnel. The facility provides reserve freezer capacity to accommodate specimens in the event of mechanical failure of a unit. Liquid nitrogen room is supplied via UPS controlled direct fill vacuum insulated piping and the space is monitored with a low oxygen monitor and external observation capability. The processing laboratory, “special handling” laboratory with a monitored negative air pressure differential, and sample receipt area are equipped with BSC’s and standard sample processing equipment. Support areas, offices and technician workspace are included. The Operations Oversight Committee is established to provide guidance from perspectives of bioethical/legal, sample management, clinical, basic science and groups with established biorepository efforts such as IU Simon Cancer Center, Susan G. Komen for the Cure Tissue Bank, and the National Cell Repository for Alzheimer's Disease operated through the Division of Hereditary Genomics. OVERVIEW RESOURCES Resources (Continued)LIST OF SERVICES QUALITY CONTROL AND ASSURANCES CONTACT INFORMATION IndianaCTSI Biorepository Core RESEARCH CONTRIBUTION The IndianaCTSI Biorepository operates in conjunction with the IndianaCTSI ICRC (Indiana Clinical Research Center). Each ICRC protocol is reviewed for sample storage needs and recommendations are made for optimal, cost effective storage practices. Current ICRC biorepository efforts support 27 protocols in 13 divisions. In support of the Susan G. Komen for the Cure tissue banking efforts, blood is stored, DNA is extracted and banked for release for breast cancer research. The IndianaBRC is preparing to provide support for similar biobanking efforts in pediatrics, cardiology, and obstetrics. The Biorepository Core Facility is funded by a construction grant from the NCRR/NIH and by the Indiana University School of Medicine. 1702 sq ft controlled environment freezer room - 66 unit capacity 963 sq ft liquid nitrogen freezer room – 300,000 specimen immediate capacity and expandable to 1,000,000 specimen capacity 1743 sq ft processing lab with BSC’s and sample processing equipment 157 sq ft “Special Handling” lab with negative differential pressure and equipment and procedures compliant with BL3 practices 294 sq ft of technician work space 94 sq ft specimen receiving laboratory 196 sq ft laboratory support room with autoclave and dry/wet ice storage 2 offices