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Clinical Trials Office and Data & Safety Monitoring

Clinical Trials Office and Data & Safety Monitoring
临床试验办公室和数据
批准号:
9248289
负责人:
GUSTAVO WALTER LEONE
金额:
$18.47万
依托单位国家:
美国
项目类别:
财政年份:
2017
资助国家:
美国
项目状态:
已结题
起止时间:
2017-04-01 至 2019-03-31

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中文摘要
翻译
霍林斯癌症中心(HCC)临床试验办公室(CTO)为开展这项工作提供了一个中央办公室 在南卡罗来纳医科大学(MUSC)进行的癌症临床试验。首席技术官的目的是 提供有效和高效的基础设施,以支持HCC调查人员开发、实施、 并报道MUSC的所有癌症临床研究。 肝细胞癌首席技术官的主要职能是: ·作为中心临床研究信息库,促进中心范围内的交流, 科目应计费用跟踪,并监测从初始到最终的所有研究进展 出版。 ·协助癌症委员会调查人员及时启动和管理研究,包括准备工作 以及科学、伦理、财务和运营审查以及持续审查所需的沟通 支持年度监管审查。 ·协助临床医生筛选和招募患者参加临床研究研究。 ·协调并确保完成针对患者的研究要求。 ·为临床研究提供数据管理支持。 ·为内部和外部质量和合规审计准备医疗和研究记录。 ·提供与开展临床研究的最佳做法有关的培训和教育 以及CTO工作人员和新的调查人员。 ·向肝细胞癌医生、参考医生和公众通报临床研究的可用性。
英文摘要
The Hollings Cancer Center (HCC) Clinical Trials Office (CTO) provides a centralized office for the conduct of cancer clinical trials at the Medical University of South Carolina (MUSC). The purpose of the CTO is to provide an effective and efficient infrastructure to support HCC Investigators in developing, implementing, and reporting on all cancer clinical research studies at MUSC. The major functions of the HCC CTO are to: • Serve as a central clinical research information repository that facilitates Center-wide communications, subject accrual tracking, and monitoring of the progression for all studies from Inception to final publication. • Assist HCC investigators in the timely activation and administration of studies, including the preparations and communications required for scientific, ethical, financial, and operational reviews as well as ongoing support for annual regulatory reviews. • Assist clinicians in screening and enrolling patients for clinical research studies. • Coordinate and ensure the completion of patient-specific study requirements. • Provide data management support for clinical research studies. • Prepare medical and research records for internal and external quality and compliance audits. • Provide training and education pertaining to the best practices in conducting clinical studies to clinical and CTO staff and new investigators. • Communicate the availability of clinical studies to HCC physicians, referring physicians, and the public.
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