(Clinical Core?Core 6) The Clinical Core (Core 6) facilitates translational research in CF human subjects and human samples. This P30 Core facility was established at the time of the last renewal due to the increasing need for organized biobanking of CF and non-CF control specimens and the increasing involvement of Center Members in clinical studies seeking to ask basic scientific questions in humans and compare these findings to the CF mouse, ferret and pig models. Major objectives of the core include assistance in recruiting and identifying patients suitable for various investigator-driven CF clinical trials and studies. This Core functions under the umbrella of the Institute for Clinical and Translational Science (ICTS) and will benefit from its resources and support for translational clinical research. The main goals of the Core are: 1. To sustain an umbrella biobank to archive biosamples collected during routine clinical visits and research-related visits, and to obtain consent from current and future CF patients for this biobank. 2. To acquire normal and CF specimens including DNA, bronchoalveolar lavage fluid (BALF), whole blood, plasma, feces, urine, and bacterial isolates. 3. To maintain databases of historical clinical samples and prospectively collected samples, including molecular typing of bacterial and other isolates when available. 4. To support a standardized process through which investigators can obtain de-identified or identified clinical information about archived clinical samples or prospectively obtained samples from routine clinical bloodwork (e.g. samples from oral glucose tolerance testing, or routine liver function monitoring) 5. To assist basic and translational researchers in obtaining specific biological samples that are not routinely banked (e.g. surgical discarded specimens such as the gallbladder following cholecystectomy). 6. To facilitate patient recruitment and enrollment in clinical trials and studies, particularly early phase trials of novel therapies and mechanistic or pathophysiology studies. 7. To assist investigators in conducting clinical trials and preparing IRB submissions, and to ensure that clinical research is conducted in accordance with the principles of Good Clinical Practice (GCP), and appropriate biostatistical analysis.
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