Clinical Sample Core

临床样本核心

• 批准号: 8516986
• 负责人: Thomas Denny
• 金额: $ 22.36万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-01 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8516986
• 关键词: Accreditation; American; B cell repertoire; Bone Marrow; Cell Count; Cells; Cessation of life; Clinical; Collection; Development; Freezing; Goals; Harvest; Infection; Influenza; Influenza A Virus, H1N1 Subtype; Instruction; Laboratories; Pathologist; Plasma; Public Health; Recovery; Research Design; Research Personnel; Saliva; Sampling; Site; Structure; Techniques; Vaccine Clinical Trial; Vaccines; Virus; Work; clinical material; college; experience; human subject; influenza virus vaccine; mortality; novel; pandemic disease

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已采集、收获和冷冻保存的高度表征的供体/临床材料（例如PBMC、血浆、骨髓、唾液等）的集合，以支持本申请中提出的项目。所有细胞材料均使用受控速率细胞冷冻技术冷冻保存，确保亚群的存活率为最初冷冻保存细胞数量的85%或更高。通常，这些临床 样本将作为正在进行的临床试验疫苗或其他类型研究的补充（例如，评估有症状或无症状感染）。临床样本管理核心监管和合规团队将确保所有人类受试者材料和MTA批准均已到位，以允许以去识别格式使用临床材料。该实验室在美国病理学家认证学院（CAP）下运作， 每年进行一次GCLP合规性审计。所有实验室活动将在GCLP后进行。 使用液氮2干燥运输箱将冻存材料从杜克临床样本管理中心运输至合作研究者实验室。