Administrative Core

行政核心

• 批准号: 7728797
• 负责人: ALAN N. HOUGHTON
• 金额: $ 24.07万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-07-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7728797
• 关键词: Biometry; Cancer Vaccines; Clinic; Clinical Research; Clinical Trials; Data; Discipline of Nursing; Grant; Immunology; Maintenance; Memorial Sloan-Kettering Cancer Center; Nurses; Nursing Research; Patient Monitoring; Patients; Pharmacists; Pharmacy facility; Play; Protocols documentation; Records; Regulatory Affairs; Research; Role; Structure; Toxic effect; United States Food and Drug Administration; Vaccines; data management; design; experience; follow-up; novel; pre-clinical; programs; quality assurance; research study

The Administrative Core includes biostatistics, clinical trials management, nursing, and pharmacy. This core plays an integral part in all projects, providing a closely interactive biostatistics group that is integrated into each Project, nursing, data management and pharmacy support for all clinical trials throughout Projects 1-3. The role of the biostatistics group for this project is to contribute to the design, conduct and analysis of the clinical trials, and preclinical experiments. The Administrative Core supports data management through the Office of Clinical Research at MSKCC. This office is responsible for patient registration, data management support, quality assurance/control, regulatory affairs and interfacing with the FDA, protocol oversight, and assisting protocol review. The data managers on this program attend meetings weekly and participate in clinic sessions where patients are treated. The Immunology Research Nurses are experienced nurses who deliver therapies including mAb and vaccines, perform patient monitoring, and record data of toxicity. Finally the research pharmacist handles and stores vaccines, and prepares them for treatment, with maintenance of appropriate records.

行政核心包括生物统计学，临床试验管理，护理和药学。这一核心 在所有项目中起着不可或缺的作用，提供了一个紧密互动的生物统计组， 每个项目，护理，数据管理和药房支持整个项目1-3的所有临床试验。 本项目生物统计组的作用是为设计、实施和分析 临床试验和临床前实验。管理核心通过 MSKCC临床研究办公室。这个办公室负责病人登记，数据管理 支持、质量保证/控制、法规事务和与FDA的接口、方案监督，以及 协助方案审查。此计划中的数据管理员每周参加会议， 病人接受治疗的诊所。免疫学研究护士是经验丰富的护士， 提供包括mAb和疫苗在内的治疗，进行患者监测，并记录毒性数据。最后 研究药剂师处理和储存疫苗，并为治疗做好准备， 适当的记录。