BEHAVIORAL/PHARMACOLOGIC TREATMENT OF ALCOHOLISM

说明：本提案的主要目标是建立一个 行为/药理学联合临床协调中心 酒精中毒患者的治疗（CBPTA）合作项目 研究协调中心（CSCC）在生物统计学系， 位于查佩尔山的北卡罗来纳州大学。 CSCC项目团队将合作开展研究 方案、操作手册和数据收集表，并提供 为他们的发展提供行政支持。我们将发挥领导作用 在制定收集、编辑、存储和 分析临床中心生成的数据。我们将开发 资格验证和随机化程序，使用 自动按键语音应答系统我们将提供培训， 临床中心工作人员参与研究程序，包括数据收集和 管理，通过书面手册和集中和 现场培训。我们将设计和实施质量控制计划， 诊断、干预实施、数据收集和中心实验室 决心。我们将为研究设计提供统计专业知识， 分析并进行所有数据分析。我们将在 编写科学出版物和介绍。我们将提供 向数据和安全性监查委员会（DSMB）提供所有必要的支持， 包括编制中期分析报告，并为下列活动提供行政支助： 指导委员会会议。我们将组织和提供行政 为指导委员会和小组委员会会议提供支助。我们将管理 研究药物的采购、包装和分发。我们将 管理任何必要IND批准的申请。我们将开发 样品和数据传输以及质量控制的适当程序， 中心实验室测定。

DESCRIPTION: The primary objective of this proposal is to establish a clinical Coordinating Center for the Combined Behavioral/Pharmacologic Treatment of Alcoholism Patients (CBPTA) project within the Collaborative Studies Coordinating Center (CSCC) in the Department of Biostatistics at the University of North Carolina at Chapel Hill. The CSCC project team will collaborate in the development of the study protocol, manual of operations, and data collection forms, and provide administrative support for their development. We will take a leadership role in developing procedures for collecting, editing, storing, and analyzing data generated by the clinical Centers. We will develop procedures for eligibility verification and randomization, using an automated touchtone, voice response system. We will provide training to clinical Center staff in study procedures, including data collection and management, through a combination of written manuals and centralized and on-site training. We will design and implement quality control programs for diagnosis, intervention delivery, data collection, and central laboratory determinations. We will provide statistical expertise for study design and analysis and perform all data analysis. We will collaborate in the preparation of scientific publications and presentations. We will provide all necessary support to the Data and Safety Monitoring Board (DSMB), including production of interim analyses, and administrative support for Steering Committee meetings. We will organize and provide administrative support for Steering Committee and subcommittee meetings. We will manage procurement, packaging, and distribution of study medications. We will manage application for any necessary IND approval(s). We will develop appropriate procedures for sample and data transfer and quality control for central laboratory determinations.