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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
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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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Leaders of Scientific Research Programs
CELL EVALUATION & THERAPY
Administration
BIOREPOSITORY & TISSUE ANALYSIS
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