Clinical Sample Core

临床样本管理核心的目标是建立和维护高度特征化的捐赠者/临床材料(例如，PBMC、血浆、骨髓、唾液等)的集合，这些材料已被收集、采集和冷冻保存，以支持本申请中提出的项目。所有细胞材料都使用受控速率的细胞冷冻技术进行冷冻保存，确保亚群的可行恢复，达到原始冷冻保存细胞数量的85%或更多。通常情况下，这些临床 样本将作为现场特定嵌套研究获得，作为正在进行的临床试验、疫苗或其他类型研究(例如，评估有症状或无症状感染)的补充。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批准到位，以允许以特定的格式使用临床材料。该实验室在美国病理学家学会认证(CAP)下运作，是 每年对GCLP合规性进行审计。所有实验室活动将在GCLP之后进行。 冷冻保存的材料将使用LN2干运输船从杜克大学临床样本管理核心运送到协查实验室。

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.