Nima Sharifi, of the Cleveland C linic Foundation, at the following address: Michael P. Berk Cleveland Clinic FoundationLerner Research InstituteCancer Biology, NB4-152111 East 96th StreetCleveland, OH 44106Tel. = 216.445.9752Email = berkm@ccf.org Version Date: 12/5/17 Abbreviated Title : Enzalutamide in non-met CSPC 374.2 S TORAGE AND TRACKING OF COLLECTED BLOOD SAMPLES All data associated with the patient samples is protected by using a secure database. All samples drawn at the NIH Clinical Center will be transported to the NCI Frederick Central Repository by couriers. Samples will be tracked and managed by Central Repository database. All samples will be stored in either a - Û&RU -Û&IUHH]HU7KHVHIUHH]HUVDUHORFDWHGDW1&,)UHGHULFN&HQW UDO Repository in Frederick, Maryland. American Type Culture Collection (ATCC) manages the NCI Frederick Central Repositories under subcontract to Leidos Biomedical Research , Inc., Frederick, Inc. NCI Frederick Central Repositories store, among other things, biological specimens in support of NIH clinical studies. All specimens are stored in secure, limited-acce ss facilities with sufficient security, backup, and emergency support capability and monitoring to ensure long-term integrity of the specimens for research. ATCC’s role is limited to clinical research databases and repositories containing patient specimens. ATCC does not c onduct or have any vested interest in research on human subjects, but does provide services and support the efforts of its customers, many of which are involved in research on human subjects. It is the intent and purpose of ATCC to acc ept only de-identified samples and sample information. To the limit of our ability, every effort will be made to ensure that protected information is not sent el ectronically or by hard copy or on vial labels. Sample data is stored in the BioSpecimen Inventory System II (BSI). This inventory tracking system is used to manage the storage and retrieval of specimens, as well as to maintain specimen data. BSI is designed for controlled, concurrent access. It provides a real-time, multi-user environment for tracking millions of specimens. The system controls how and in what order database updates and searches are performed. This control prevents deadlocks and race conditions. For security, BSI has user password acce ss, 3 types of user access levels, and 36 user permissions (levels of access) that can be set to control access to the system functions. BSI provides audit tracking for processes that are done to specimens including shipping, returning to inventory, aliquoting, thawing, additives, and other processes. BSI tracks the ancestry of specimens as they are aliquoted, as well as discrepancies and disc repancy resolution for specimens received by the repository. If a specimen goes out of the inventory, the system maintains data associated with the withdraw re quest. Vials are labeled with a unique BSI ID which is printed in both eye-readable and bar-co ded format. No patient-specific information is encoded in this ID. Investigators are granted view, input, and withdraw authority only for their specimens. They may not view specimen data or access specimens for which they have not been authorized. Access to specimen storage is confined to repository staff. Visitors to the repositories are escorted by repository staff at all times. Samples will be used for research analysis, including immunologic monitoring as outlined in section 4.1.3. All specimens for analysis will be requested from Leidos Biomedical Research, Version Date: 12/5/17 Abbreviated Title : Enzalutamide in non-met CSPC 38Inc. and will be delivered by Leidos Biomedical Research, Inc.