Biorepository core

摘要 I-HAB将支持多个H3 Africa研究人员，这些研究人员构成了SickleGenAfrica U 54中心的赠款， 在多个非洲国家开展镰状细胞病的高质量基因组学和转化研究 使用经过良好加工、保存和质量控制并得到充分保护的人类生物制品的国家 H3 Africa和更大的研究社区可以获得的样本。为实现这一目标，I-HAB的目标是5 具体目标：目标1：建立一个高质量的原始人类生物样本和遗传学样本的生物储存库。 材料符合GLP和ISBER指南。目标2：实施、管理和支持强大的云 基于计算的生物信息学工具，也可用于SickcleGenAfrica项目和临床研究中心， 自动化样品管理，以保护它们，同时提供高效的存储、检索和 监管信息，以满足GLP和ISBER指南。目标3：建立质量保证/质量控制 (QA/QC）程序，以确保科学过程和生物储存库的完整性。目标4： 对SickcleGenAfrica员工进行短期和中期、本地和国际培训和指导， 生物储藏科学，以确保H3非洲生物储藏库的持续高质量功能。目标5： 将生物贮藏库伦理方面的最佳做法纳入生物贮藏库的职能，以确保符合文化的伦理 非洲基因组学研究的生物库规范和实践。IHVN的H3非洲生物储存库 根据其过去在西非地区支持其他H3 Africa项目的经验， 实施高质量的生物储存服务，以支持SickleGenAfrica及其临床研究中心。核心 领导人提供了宝贵的见解，以管理和互动之间的镰刀基因非洲 领导团队以实现最佳协同和协调。I-HAB将提供可靠的样品处理支持， 安全运输、快速获取和记录样本质量、可获得的临床和 流行病学数据和样本的数量和质量，可靠的检索和积极促进 合作以实现最佳科学和可持续的实践和资金。持续质量改进 可靠的存储库功能和来自最终用户的持续反馈促进了对服务交付的信任， 产品质量

Abstract I-HAB will support multiple H3Africa investigators that make up the SickleGenAfrica U54 center grant to conduct high quality genomics and translational research in sickle cell disease across multiple African countries using well processed, preserved and quality controlled and redundantly protected human biological samples accessible to the H3Africa and larger research community. To achieve this goal the I-HAB targets 5 Specific Aims: Aim 1: Implement a high quality biorepository of primary human biologic samples and genetic materials in compliance with GLP and ISBER guidelines. Aim 2: Implement, manage and support robust cloud computing based bioinformatics tool that is also accessible to SickcleGenAfrica project and clinical sites to automate management of samples to protect them while providing efficient storage, retrieval, and chain of custody information to meet GLP and ISBER guidelines. Aim 3: Establish Quality Assurance/Quality Control (QA/QC) procedures to ensure the integrity of scientific process and biorespository sustainably. Aim 4: Conduct short and medium, local and international training and mentoring of SickcleGenAfrica staff on Biorepository Sciences to ensure continued high quality functions of the H3Africa Biorepository. Aim 5: Integrate best practices in biorepository ethics into biorepository functions to ensure culturally relevant ethical norms and practices around biobanking for genomics research in Africa. IHVN's H3Africa Biorepository builds on its past experience from supporting other H3Africa projects in the West African region to ensure that quality biorespository service implementation to support the SickleGenAfrica and its clinical sites. The core leader provides valuable insights to the administration and interaction between the SickleGenAfrica leadership team for optimal synergism and coordination. I-HAB will provide reliable sample processing support, secure shipping, rapid accession and documentation of sample quality, accessible information on clinical and epidemiological data and sample quantity and quality, reliable retrieval and proactive facilitation of collaboration to achieve best science and sustainable practice and funding. Continuous quality improvement for reliable repository function and ongoing feedback from end users fosters trust in service delivery and product quality.