Should a CRIS screen not be available, the CRIS downtime procedures will be followed. Samples will not be sent outside NIH without IRB notification and an executed MTA. 4.3.1 Samples sent to Clinical Services Program (CSP) 4.3.1.1 Storage 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. Samples will be tracked and managed by the Central Repository database. All samples will be stored in liquid nitrogen. These freezers are located at NCI Frederick Central Repository in Frederick, Maryland. A subcontractor manages the NCI Frederick Central Repositories under subcontract to Leidos Biomedical Research, Inc. NCI Frederick Central Repositories store, among other things, biological specimens in support of NIH clinical studies. All specimens are stored in secure, limited access facilities with sufficient security, back-up and emergency support capability and monitoring to ensure long-term integrity of the specimens for research. The subcontractor’s role is limited to clinical research databases and repositories containing patient specimens. It does not conduct nor has any vested interest in research on human subjects, 38 Short Title: Enzalutamide Vaccine in mCRPC Version Date: 03/29/2022 but does provide services and supports the efforts of its customers, many of which are involved in research on human subjects. It is the intent and purpose to accept only de-identified samples and sample information.