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.
Showing the most recent 10 out of 17 publications
