NIAID SPECIMEN REPOSITORY

NIAID 样本库

• 批准号: 9988296
• 负责人: DEBORAH PHIPPARD
• 金额: $ 359.22万
• 依托单位: PRECISION BIOSERVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-30 至 2020-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9988296
• 关键词: AIDS Treatment Research; AIDS Vaccines; AIDS clinical trial group; Acquired Immunodeficiency Syndrome; Adult; Aliquot; Biological; Catalogs; Childhood; Clinical; Cohort Studies; Contracts; Cryopreservation; Database Management Systems; Ensure; Epidemiology; Equipment and supply inventories; Freezing; Future; HIV; HIV Vaccine Trials Network; HIV prevention trials network; Heterosexuals; Human; Human Resources; National Institute of Allergy and Infectious Disease; Procedures; Process; Quality Control; Secure; Services; Shipping; Ships; Specimen; Support System; Technology; The Multicenter AIDS Cohort Study; Women’s Interagency HIV Study; computerized; novel; operation; programs; quality assurance; repository; transmission process; vaccine evaluation

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).

该合同将提供与NIAID标本库（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、储存和分发来自参与艾滋病司（DAIDS）赞助的队列研究和临床网络的受试者的人类生物标本（2）提供足够的冷藏设施，（3）保持最新的临床标本优化储存新程序，并能够使用最先进的技术，以确保从接收到储存在冰柜中以及从冰柜到装运容器的完整性，以便进行装运，（4）提供（或利用当前的）支持储存库功能的计算机化样本库存数据库管理系统（SIDMS），以及（5）开发、执行、并根据所有适用的联邦、州和地方法规要求，维护NSR设施、操作、储存生物标本、运输材料和人员的质量保证（QA）/质量控制（QC）计划。NSR将支持以下正在进行的NIAID研究小组，按储存标本数量从多到少的顺序排列：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）;和艾滋病毒预防试验网络（HPTN）。NSR还将保存来自其他NIAID赞助的研究的标本，这些研究要么已经完成，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）;艾滋病治疗研究倡议部（DATRI），或来自目前将新生成的标本送到另一个储存库的研究小组，例如成人和儿童艾滋病临床试验组（AACTG）。