NIAID SPECIMEN REPOSITORY

该合同将提供与 NIAID 样本库 (NSR) 运营相关的急需的综合服务，并将继续帮助 (1) 保护、接收、编目、处理、等分、存储和分配来自参与艾滋病司 (DAIDS) 赞助的队列研究和临床网络的受试者的人类生物样本 (2) 提供足够的冷藏设施，(3) 保持最新的临床样本优化存储程序，并能够使用最先进的技术来确保样本完整性接收到冷冻柜中的储存以及从冷冻柜到装运集装箱以进行发货，(4) 提供（或使用当前的）支持存储库功能的计算机化样本库存数据库管理系统 (SIDMS)，以及 (5) 根据所有适用的联邦、州和地方法规要求，为 NSR 设施、运营、存储的生物样本、运输材料和人员制定、执行和维护质量保证 (QA)/质量控制 (QC) 计划。 NSR 将支持以下正在进行的 NIAID 研究小组，按存储样本数量从大到少的顺序排列： 妇女机构间艾滋病毒研究 (WIHS)；多中心艾滋病队列研究（MACS）； HIV 疫苗试验网络 (HVTN)；和艾滋病毒预防试验网络（HPTN）。 NSR 还将保留 NIAID 资助的其他已完成研究的样本，例如：艾滋病疫苗评估小组（AVEG）；艾滋病毒传播网络（HIVNET）；快速启动项目；异性恋艾滋病毒传播研究（HATS）；艾滋病治疗研究计划 (DATRI) 部门，或目前将新生成的样本发送到另一个存储库的研究小组，例如成人和儿童艾滋病临床试验小组 (AACTG)。

This contract will provide critically needed comprehensive services related to operation of the NIAID Specimen Repository (NSR), and it will continue to help (1) secure, receive, catalog, process, aliquot, store, and disburse human biological specimens from subjects participating in Division of AIDS (DAIDS)-sponsored cohort studies and clinical networks (2) provide adequate cold storage facilities, (3) remain current on novel procedures for optimized storage of clinical specimens and be able to use state of the art technology to ensure specimen integrity from receipt to storage in the freezers and from freezers to shipment containers for outgoing shipments, (4) provide (or utilize the current) computerized Specimen Inventory Database Management System (SIDMS) that supports the repository's functions, and (5) develop, perform, and maintain Quality Assurance (QA)/Quality Control (QC) Program for the NSR facility, operations, stored biospecimens, shipping materials, and personnel in accordance with all applicable Federal, State, and local regulatory requirements. The NSR will support the following ongoing NIAID study groups, noted in order of greatest to least numbers of stored specimens: The Women's Interagency HIV Study (WIHS); The Multicenter AIDS Cohort Study (MACS); the HIV Vaccine Trials Network (HVTN); and the HIV Prevention Trials Network (HPTN). The NSR also will maintain specimens from other NIAID-sponsored studies that either have been completed, such as; the AIDS Vaccine Evaluation Group (AVEG); the HIV Transmission Network (HIVNET); the Jump Start Project; the heterosexual HIV Transmission Study (HATS); the Division Of AIDS Treatment Research Initiative (DATRI), or from study groups that currently send newly-generated specimens to another repository, such as the Adult and Pediatric AIDS Clinical Trials Group (AACTG).