The Clinical Studies Core, staffed with experienced individuals who are experts in their respective fields, is an integral component of the Gaston P01 program, 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 assist investigators in accessing, selecting, recruiting, and retaining asthma subjects and healthy volunteers; to assist in planning, development, and execution of clinical projects according to good clinical practices; to manage IRB and regulatory submissions along with post-approval tasks; and to provide oversight and/or performance of tests, procedures, collection and processing of human specimens. Additionally, this core facilitates the translation of discoveries made by basic science investigators into clinical investigation, assists investigators by entering clinical study data into a team-accessible Part 11 compliant database, maintains a bank of data, tissues and samples collected from current and former patients/subjects, and finally, assists 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. From this support, investigators can generate hypotheses that are in turn returned to basic science laboratories for more detailed investigation.