Alliance Management and Resources
- Project Management and Clinical Trial Monitoring: The Project Management team coordinates protocol development, regulatory approval where applicable, study-specific training, study initiation, and study close-out. The team provides oversight of the study team with respect to managing timelines and tracking overall study progress. The team collaborates closely with the study investigators and staff to ensure that high quality standards are maintained. For clinical trials, the team helps to ensure adequacy of subject confidentiality, informed consent procedures, and adverse event reporting through clinical site monitoring. Additionally, the Clinical Management team is the primary point of communication to the Consortium Leadership team on study progress including helping to identify and develop solutions for study conduct concerns.
- Biostatistics: The Biostatistics team collaborates with study investigators on study design including determining appropriate study objectives, hypotheses, endpoints, analytic approaches, and sample size as well as designing and implementing treatment allocation schemes. The team also provides support to the study team and Consortium Leadership for centralized study monitoring, performing study analyses, participating in abstract and manuscript development, and reporting to the Data and Safety Monitoring Board (DSMB) and Food and Drug Administration (FDA) where applicable.
- Informatics: The Informatics team leads the development of study case report forms and has the primary responsibility for data quality. Studies are supported through the use of robust, secure electronic data entry and management systems that are implemented in a manner to ensure consistency across Consortium studies, as well as compliance with federal regulations, but also allow for flexibility to meet the specific needs of each study.
- Regulatory Affairs and Compound Development: The Regulatory Affairs and Compound Development team provides the main liaison with the FDA. The team works with each study to develop a regulatory and development plan that will support the rapid progression of any potentially beneficial compounds toward approval for clinical treatment of alcohol and substance use disorders (ASUD).
- Human Subjects Protection: The Human Subjects Protection team coordinates all aspect of Institutional Review Board (IRB) approvals and other forms of human subjects protection. The team works with each clinical site to obtain the necessary approvals and maintain records of the approvals.
- Site and Subject Recruiting: The Recruitment team is available to facilitate collaboration between applicants and military and Veteran medical centers. The Recruitment Core has many contacts at military treatment facilities (MTFs) across the nation and will assist in identifying and recruiting additional sites, particularly MTFs, for the conduct of clinical studies. The Alliance also has contacts at many VA medical centers (VAMCs) that can be used to establish VAMC collaborators and clinical sites to support clinical studies.
- Imaging Management: The Neuroimaging team is located at Baylor College of Medicine (BCM), and includes experts from the fields of neuroradiology, neuropsychology, magnetic resonance imaging (MRI) physics, information technology and computer programming, and statistics. For studies with imaging components, the team will facilitate sequence development and pulse programming; training and supervision of technologists and support personnel; and acquisition, transfer and storage of imaging data, quality assurance (QA), and conventional and advanced imaging analysis and interpretation.