CORA Project - Gene Therapy for Metachromatic Leukodystrophy

CORA 项目 - 异染性脑白质营养不良的基因治疗

• 批准号: 8382192
• 负责人: CHARLEEN HOLLMANN
• 金额: $ 9.18万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8382192
• 关键词: Advisory Committees; Clinical; Clinical Protocols; Clinical Trials Cooperative Group; Collection; Complex; Conduct Clinical Trials; Consultations; Data; Data Analyses; Data Collection; Development; Development Plans; Electronics; Eligibility Determination; Ensure; Ethics; Funding; Gene Transfer; Grant; Human; Individual; Institution; Institutional Review Boards; Investigational New Drug Application; Metachromatic Leukodystrophy; Monitor; National Institute of Neurological Disorders and Stroke; Patients; Preparation; Process; Recombinants; Regulatory Affairs; Reporting; Research Subjects; Series; System; Time; Training; United States Food and Drug Administration; United States National Institutes of Health; computerized data processing; data management; design; experience; gene therapy; human study; institutional biosafety committee; operation; protocol development; quality assurance; statistics

Team 4 - Clinical Operations/Regulatory Affairs (CORA; development of the clinical protocol, preparation, submission and obtaining approval from the IRB, IBC, NIH OBA/RAC and FDA, and preparation of SOPs and collection of documents)

团队4 -临床运营/法规事务（CORA;制定临床方案，准备、提交并获得IRB、IBC、NIH OBA/RAC和FDA的批准，以及准备SOP和收集文件）