Severe Asthma Clinical Studies Core

PROJECT SUMMARY/ABSTRACT Core C The Clinical Studies Core is an integral component of the PPG as it is designed to facilitate the conduct of clinical trials outlined in the three individual projects through economy of scale and coordinated resources. Specific objectives of the Clinical Studies Core are to 1) Assist investigators in accessing, selecting, recruiting, and

retaining asthma subjects and healthy volunteers, 2) Assist investigators in planning, developing, and execution of clinical projects and ensuring that all clinical trials meet good clinical practices, 3) Manage IRB and regulatory submissions along with post-approval filings and compliance, 4) Provide oversight and/or performance of tests

and procedures, 5) Provide oversight to the collection and processing of human specimens, 6) Facilitate the translation of discoveries made by basic science investigators into clinical investigation, 7) Assist investigators by entering clinical study data into a Part 11 compliant database, 8) Maintain a bank of data, tissues and samples

collected from current and former patients/subjects, 9) Provide access to databases to all investigators, and 10) Assist investigators in data analyses and manuscript preparation. This Core makes available our well- characterized asthma populations in both Indianapolis and Cleveland for clinical studies and facilitates the bench

to bedside translation of ideas from our basic science laboratories. The Core-supported clinical projects also generate hypotheses that are in turn returned to basic science laboratories for more detailed investigation. The Clinical Studies Core is staffed with experienced individuals who are experts in their respective fields.