There are 4 major functions the Cystic Fibrosis Clinical Core serves:
- Banking Biological Samples. The clinical core was established to facilitate translational research in cystic fibrosis (CF) human subjects and to create a biological repository (a.k.a biobank) of human CF and non-CF samples. One of the key major activities of this core was to create an umbrella biobank to archive biosamples collected during routine clinical visits and research-related visits, and to consent current and future CF patients for this biobank. While the current needs are mainly for serum and bronchoalvelolar lavage fluid (BALF), we also are approved to bank other types of samples, including: DNA; whole blood; feces; urine; and bacterial isolates. We continue to maintain databases of historical clinical samples and prospectively collected samples, including molecular typing of bacterial isolates when available. As part of the IRB submission, we have created a portal through which investigators can request de-identified clinical information about archived clinical samples (e.g. first-time isolate of Pseudomonas aeruginosa, isolates of chronic Pseudomonas, or isolates of mucoid Pseudomonas).
- Sharing samples. A second major function of this Core is to assist basic and translational researchers in obtaining specific biological samples and/or de-identified clinical information.
- Facilitating clinical research. A third major function of the Core is to facilitate clinical research by other researchers. The first direction in this activity is assistance in patient recruitment and enrollment in clinical trials, particularly early phase trials of novel therapies. The other direction is in preparing IRB submissions, and to ensure that clinical research is conducted in accordance with the principles of Good Clinical Practice (GCP).
- Study Design and Biostatistical Analysis. A final major function of the Core is to assist researchers in study design, protocol development and biostatistical analysis of study data.