Providing a resource (Clinical Study Coordinator) with particular expertise in effectively addressing NIH, IRB and HIPAA policies and reporting requirements concerning confidentiality, inclusion of women, children and ethnic/minority participation in clinical studies, data and safety monitoring requirements; and educational requirements for the protection of human research participants. As recognized recently, perhaps the least appreciated (but most important) barrier to translational and clinical research is the limited availability of administrative support for translation at most academic medical Centers [1; 2]. With the increasing regulatory requirements for translational and clinical research, worthwhile studies are currently being abandoned simply because of the burden of regulatory compliance [1]. The main objective of the clinical component of the Yale Liver Center is to alleviate this regulatory burden by providing this resource. This resource is of particular importance for Yale investigators since patients for clinical trials are recruited from both Yale-New Haven Medical Center and from the CT-VA Healthcare System, and each of them have separate IRBs and separate regulatory requirements. Additionally, this resource will maintain a patient, serum and DNA data and aid in the identification (through the clinical and sample databases) and recruitment of subjects for translational and clinical studies. This resource will constitute a bridge between Center basic science investigators and clinical investigators and among clinical investigators. b) Providing a resource (Biostatistician) that provides assistance to basic researchers with clinical study design, particularly for small pilot projects that are the initial step in the translational process. For established clinical investigators using the clinical component, this resource will provide consultation for clinical study/trial development particularly in establishing sample size calculations and advise regarding the most appropriate study design. c) Providing the opportunity for Center members to obtain patient data and clinical (serum, liver, DNA) samples needed for their research, including data regarding the number of patients available to evaluate study feasibility and estimated times for patient recruitment into clinical trials. This service will be provided through the Patient Database and the Serum, Liver Biopsy and DNA banks that will be maintained by the Clinical Study Coordinator.
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