Clinical Studies Core

临床研究核心 临床研究核心将参与任何需要患者同意的孢子研究， 标本采集和/或基于方案的治疗。核心将提供一个拱形结构。 在孢子和达纳-法伯/哈佛癌症中心内，将不再需要创建 每个临床机构都有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符合以下条件的患者的同意 包括在核心3所述的队列研究中。最后，临床研究核心将为 研究人员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： 协调审查、准备和激活孢子中所有临床研究 通过以下方式支持所有活跃的孢子临床研究： ？招募和同意患者参加临床研究 ？临床研究病人的管理和随访 ？应计和毒性监测、数据管理 ？就数据收集、组织和血液样本的储存以及重新联系的许可获得同意 用于乳腺癌女性和乳腺癌高危女性的队列研究

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