The Human Subjects and Data Intergration Core will provide a core resource for the recruitment of human participants for clinical studies of mucus pathology in CF and asthma and for intergrating data from multiple program sources to facilitate communication and promote the translation plan. Recruiting human subjects for mechanism-oriented clinical research protocols requires well-developed systems to ensure successful subject recruitment and the collection of high quality biospecimens from well-characterized human subjects. Dr. Stephen Lazarus - a highly experienced clinical researcher - currently PI of UCSF AsthmaNet and UCSF COPD CCRN - will direct the core, which will have two Aims. His Core B team will include personnel with experience in pulmonary medicine, administration of clinical research, clinical coordination, biostatistics and data management. The core will have two specific Aims:
Aim 1 will recruit and enroll human subjects for clinical research protocols to support the three tPPG projects. Specifically, to fulfill the clinical aims of Projects 1, 2, and 3, the core will be responsible for recruiting and enrolling participants with asthma, CF, and healthy controls and in providing support for a Phase 1a study to be performed by a specialist CRO.
Aim 2 will develop and maintain an integrated data management and integration systems for the tPPG. Specifically, Aim 2 will develop a data integration platform that will enable efficient real-time data sharing across partner institutions and ensure that physical distances between partner projects and institutions are not a limiting factor in the success of this tPPG.
Core B will provide a core resource for the recruitment of human participants for clinical studies of mucus pathology in CF and asthma and for integration of data from multiple sources in the program. The core is essential to the translational goals of the tPPG and will be a key component of the overall program.
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