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 临床研究核心将参与任何需要患者同意的孢子研究， 标本获取和/或基于方案的治疗。核心将提供一个过度的拱形结构 在孢子和达纳 - 法伯/哈佛癌中心内，将消除创造的需求 每个临床机构中的基于项目的研究团队。核心将提供直接支持 对于项目1、2、3和4。此外，临床研究核心将获得所有患者的同意 核心3中描述的队列研究中包括。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的是： �协调孢子中所有临床研究的审查，准备和激活 通过以下方式支持所有活跃的孢子临床研究： �招募和患者同意临床研究 „对临床研究的患者管理和随访 »监测准确性和毒性，数据管理 �获得数据收集，融入组织和血液标本的同意以及重新接触的允许 用于乳腺癌女性和那些患乳腺癌高风险的女性的队列研究