Clinical Sample Core

临床样本核心

• 批准号: 8329281
• 负责人: Thomas Denny
• 金额: $ 27.46万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-01 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8329281
• 关键词: Accreditation; American; Antibodies; B cell repertoire; Bone Marrow; Cell Count; Cells; Cessation of life; Clinical; Clinical Trials; Collection; Development; Equipment and supply inventories; Exposure to; Freezing; Goals; Grant; Harvest; Immune response; Individual; Infection; Influenza; Influenza A Virus, H1N1 Subtype; Instruction; International; Laboratories; Mission; Pathologist; Peripheral Blood Mononuclear Cell; Plasma; Process; Public Health; Publications; Reagent; Recovery; Research Design; Research Personnel; Saliva; Sampling; Site; Structure; Techniques; Vaccine Clinical Trial; Vaccines; Virus; Wood material; Work; clinical material; college; experience; human subject; influenza virus vaccine; mortality; novel; pandemic disease; programs; repository; response

The goal of the clinical sample management core is to establish and maintain a collection of highly characterized donors/clinical material (e.g. PBMCs, plasma, bone marrow, saliva, etc) that have been collected, harvested and cryopreserved to support the projects proposed in this application. All cell material is cryopreserved using controlled rate cells freezing techniques that assure viable recovery of subsets at 85% or greater of the number of cells originally cryopreserved. Typically, these clinical samples will be acquired as site specific nested studies that are additions to ongoing clinical trials vaccine or other type of studies (e.g., assessing symptomatic or asymptomafic infecfion). The clinical sample management core regulatory and compliance team will assure that all human subject materials and MTA approvals are in place to permit use of the clinical material in a de identified format. The laboratory operates under College of American Pathologists Accreditation (CAP) and is audited annually for GCLP compliance. All laboratory activifies will be performed following GCLP. Cryopreserved materials will be transported from the Duke clinical sample management core to co-investigator laboratones using LN2 dry shippers.

临床样本管理核心的目标是建立和维护高度特征的供体/临床材料（如pbmc、血浆、骨髓、唾液等）的收集、收获和冷冻保存，以支持本申请中提出的项目。所有细胞材料都使用控制率细胞冷冻技术进行冷冻保存，以确保亚群的存活恢复率达到最初冷冻保存细胞数量的85%或更高。通常，这些临床