Clinical Sample Core

临床样本核心

• 批准号: 8893873
• 负责人: Thomas Denny
• 金额: $ 18.66万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8893873
• 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.

临床样品管理核心的目的是建立和维护高度特征的供体/临床材料（例如PBMC，血浆，血浆，骨髓，唾液等），这些材料已收集，收获和冷冻保存，以支持该应用程序中提出的项目。所有细胞材料均使用受控速率电池冷冻保存，以确保在最初冷冻保存的细胞数量的85％或以上的子集的生存恢复。通常，这些临床 样品将作为特定地点的嵌套研究获取，这些研究是正在进行的临床试验疫苗或其他类型的研究（例如，评估有症状或渐进性的无效）。临床样本管理核心监管和合规团队将确保所有人类主题材料和MTA批准都允许以DE确定格式使用临床材料。该实验室在美国病理学家学院认证（CAP）的领导下运营，是 每年审核GCLP合规性。 GCLP后将进行所有实验室激活。 冷冻保存的材料将从杜克临床样本管理核心运输到使用LN2干托运人的共同投资者的劳动力。