Clinical Research Core

M. D.安德森癌症中心淋巴瘤孢子临床研究的核心是 通过1）协调临床试验的发展， 2)协助患者招募，3）向适当机构报告不良事件，以及4）提供质量 控制临床试验数据。临床研究核心提供了临床研究和 具体项目和核心。临床研究核心由Anas Younes，MD和Peter共同指导 McLaughlin，MD.临床研究核心的其他关键成员是研究护士经理， 法规合规协调员、数据分析师/审计员和高级执业护士/研究 护士研究护士经理将负责监督核心研究中心的所有研究护士， 确保他们得到适当的训练。监管合规协调员将负责所有 方案提交、批准、修订以及与机构沟通的监管方面 审查委员会（IRB）和申办者。数据分析员/稽查员将对方案进行定期稽查， 高级实践护士将负责研究人员的继续教育。的 临床研究中心将为所有项目和参与项目的研究者提供支持。临床 研究核心将与生物统计核心互动，进行临床试验的统计设计，并将 向生物统计核心提供基于临床的患者数据。它还将与生物标本核心相互作用 获取和运输人体标本，以及提供与标本相关的临床数据。 该核心还将与行政核心互动，协调研究和沟通， NCI和其他淋巴瘤SPORE计划。 相关性（参见说明）： 临床研究核心将协调本SPORE中提出的临床研究的所有方面 申请，包括在MDACC和UNMC进行的临床试验。本申请有4个IRB- 在本提案的第一年批准招募患者的研究。

The primary goal of the M. D. Anderson Cancer Center Lymphoma SPORE Clinical Research Core is to bridge the translational research with clinical research by 1) coordinating the development of clinical trials, 2) assisting in patient accrual, 3) reporting adverse events to appropriate agencies, and 4) providing quality control on clinical trial data. The Clinical Research Core provides a critical link between clinical research and the specific projects and cores. The Clinical Research Core is co-directed by Anas Younes, MD, and Peter McLaughlin, MD. Other key members of the Clinical Research Core are the Research Nurse Manager, Coordinator of Regulatory Compliance, Data Analyst/Auditor, and Advanced Nurse Practitioner/Research Nurse. The Research Nurse Manager will be responsible for supervising all research nurses in the core and ensuring their proper training. The Coordinator of Regulatory Compliance will be responsible for all regulatory aspects of protocol submission, approval, amendments, and communication with the Institutional Review Board (IRB) and the sponsor. The data analyst/auditor will perform periodic audits on protocols, and the Advanced Practice Nurse will be responsible for continuing education for the research staff. The Clinical Research Core will provide support to all projects and investigators involved in Projects. The Clinical Research Core will interact with the Biostatistics Core for the statistical design of clinical trials and will provide clinically-based patient data to the Biostatistics Core. It will also interact with the Biospecimens Core by procuring and transporting human specimens and by providing clinical data related to the specimens. The Core will also interact with the Administrative core to coordinate studies and communication with the NCI and other lymphoma SPORE programs. RELEVANCE (See instructions): The Clinical Research Core will coordinate all aspects of clinical research proposed in this SPORE application, including clinical trials conducted at MDACC and the UNMC. This application has 4 IRB- approved studies enrolling patients in the first year of this proposal.