Clinical Studies Core

临床研究核心

• 批准号: 7729491
• 负责人: ERIC P WINER
• 金额: $ 23.92万
• 依托单位: DANA-FARBER CANCER INST
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-01 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7729491
• 关键词: Authorization documentation; Blood specimen; Cancer Center; Clinical; Clinical Protocols; Clinical Research; Cohort Studies; Consent; Data Collection; Development; High Risk Woman; Individual; Institution; Monitor; Patients; Preparation; Protocols documentation; Recontacts; Reproduction spores; Research Personnel; Specimen; Structure; Tissue Banking; Toxic effect; Woman; base; data management; follow-up; malignant breast neoplasm

Clinical Studies Core The Clinical Studies Core will be involved in any SPORE study that requires patient consent, specimen acquisition, and/or protocol-based treatment. The core will provide an over arching structure within the SPORE and the Dana-Farber/Harvard Cancer Center that will eliminate the need to create individual project-based study teams in each of the clinical institutions. The Core will supply direct support to Projects 1, 2, 3, and 4. In addition, the Clinical Studies Core will obtain consent from all patients who are included in the cohort studies described in Core 3. Finally, the Clinical Studies Core will provide support to investigators to expedite the development, review, and activation of all clinical protocols. The specific aims of the Clinical Studies Core are: ¿ To coordinate the review, preparation, and activation of all clinical studies in the SPORE ¿ To support all active SPORE clinical studies through: ¿ Recruitment and consent of patients to clinical studies ¿ Management and follow-up of patients on clinical studies ¿ Monitoring of accrual and toxicity, data management ¿ To obtain consent for data collection, banking of tissue and blood specimens, and permission to recontact for cohort studies in women with breast cancer and those women at high risk of developing breast cancer

临床研究核心 临床研究中心将参与任何需要患者同意的SPORE研究， 标本采集和/或基于方案的治疗。核心将提供一个覆盖结构 在SPORE和Dana-Farber/哈佛癌症中心内， 在每个临床机构中建立单独的基于项目的研究团队。核心将提供直接支持 项目1、2、3和4。此外，临床研究核心将获得所有患者的同意， 纳入核心3中描述的队列研究。最后，临床研究核心将提供支持， 研究者加快所有临床方案的开发、审查和激活。 临床研究核心的具体目标是： 协调SPORE中所有临床研究的审查、准备和启动 通过以下方式支持所有正在进行的SPORE临床研究： 患者的招募和同意临床研究 â临床研究患者的管理和随访 监测累积和毒性，数据管理 获取数据收集、组织和血液样本库的同意，以及重新联系的许可 用于乳腺癌女性和乳腺癌高危女性的队列研究