NIAID SPECIMEN REPOSITORY

该合同将提供与NIAID标本储存库(NSR)运营相关的迫切需要的全面服务，并将继续帮助(1)保护、接收、编目、处理、等量、存储和支付来自艾滋病(DAIDS)赞助的队列研究和临床网络的受试者的人体生物标本(2)提供足够的冷藏设施，(3)保持最新的临床标本存储的新程序，并能够使用最先进的技术来确保标本从接收到存储在冷冻箱中以及从冷冻箱到出货集装箱的完整性，(4)提供(或利用最新的)计算机标本库存数据库管理系统(SIDMS)来支持存储库的功能，以及(5)根据所有适用的联邦、州和地方法规要求，为NSR设施、操作、储存的生物样品、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，按储存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)；艾滋病毒疫苗试验网络(HVTN)；以及艾滋病毒预防试验网络(HPTN)。NSR还将保存来自NIAID赞助的其他研究的样本，这些研究要么已经完成，要么来自艾滋病疫苗评估小组(AVEG)；艾滋病毒传播网络(HIVNET)；Jump Start项目；异性艾滋病毒传播研究(HATS)；艾滋病治疗研究行动司(DATRI)；或者来自目前将新产生的样本发送到另一个储存库的研究小组，如成人和儿童艾滋病临床试验小组(ACTG)。

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).