The CTNA places a high priority on maintaining an efficient flow of information in order to promote the safe and successful completion of proposed studies, to support the initiation of novel pilot studies, to facilitate the career development of trainees and junior faculty affiliated with the Center, and to promote the dissemination of research advances. The Administrative Core provides for the centralized organizational functions of the CTNA. The executive functions, budget functions and data management components are the heart of CTNA, serving as the focus of all activities.
Data Management & Biostatistical Component (DMBC)
The Administrative Core oversees centralized data management for all CTNA components. The Data Management and Biostatistics Component (DMBC) is directed by Dr. Ralitza Gueorguieva. Data are entered using a novel data management system via Teleforms managed by Elaine LaVelle. All members of the DMBC are experienced in study design, preparation of study forms, management of data, preparation of reports related to the progress of each study.
Data Safety Monitoring Board (DSMB)
CTNA puts the highest possible emphasis on the protection of subjects participating in its research activities. The establishment of the DSMB within this Center minimizes the exposure of research subjects to procedures that may carry risk. The DSMB is extrinsic to the CTNA infrastructure to provide an additional level of protection for subjects. This step is taken for two reasons, 1) Cutting-edge clinical neuroscience research as it is implemented in the CTNA may involve exposure to radiation (e.g., PET neuroreceptor imaging), drugs that may have unpleasant effects, or procedures that could conceivably worsen the course of alcoholism (e.g., ethanol self-administration in non-treatment-seeking alcoholics). The proposed studies are designed in accord with NIAAA guidelines for alcohol administration, NAMI recommendations regarding the ethical conduct of research, and related recommendations from the ACNP. The inclusion of these technologies in the CTNA followed careful consideration of the potential scientific merit of each study, the risk/benefit issues for research subjects and society, and approval by the Yale-affiliated IRBs (Yale, Columbia, Hartford Hospital and VACHS IRBs). The establishment of the DSMB insures that the clinical studies will not be continued long after the data collected has answered the proposed scientific aims or when it is unlikely to be concluded successfully, thus placing subjects at avoidable potential risk. 2) The collaboration with the Data Management and Biostatistics Component (DMBC) of the Clinical Core provides the Center with an infrastructure that is capable of preparing detailed reports on safety and efficacy for each clinical study every 6 months. This capacity, out of reach for most single-site studies, assures that the DSMB has the information necessary to perform its monitoring functions.
Scientific Advisory Board (SAB)
The SAB reviews all ongoing projects and planned pilot studies to assure that the transdisciplinary goals of the CTNA are maintained. Investigators present an update of each ongoing project to the SAB. Members of the SAB are asked to provide critical assessments and suggestions for continuation, enhancement, change, or closure of projects. The SAB reports to Dr. Krystal to provide guidance on the most appropriate conduct of the CTNA. Selection of SAB members was based on the need for a multidisciplinary group that could provide advice on all aspects of the CTNA.