GRANT BOILERPLATE LANGUAGE FACILITIES AND RESOURCES Pulmonary Translational Research Core (PTRC) The mission of the PTRC is to foster excellence in research from the lab bench to patient bedside to clinical practice and to advance patient care and health outcomes in the field of pulmonary medicine. The PTRC aims to provide the resources, services, operations, and training to support and promote the planning and implementation of translational and clinical research in the Division of Pulmonary, Allergy, and Critical Care Medicine (PACCM) at the University of Pittsburgh. PTRC offers a broad range of consultations and key regulatory supports at all stages throughout the research project life cycle from grant writing, developing a protocol, through recruiting participants to closing the research project and analyzing the results. Translational Core: The PTRC Translational Core provides centralized resources with well-controlled, highquality human biological specimens annotated with essential clinical data for broad investigational use, facilitating biospecimen science studies that form the basis of evidence-based practices to guide clinical pulmonary research in the Division of PACCM. Collaborating with the Division’s Core Laboratory Facilities (eg: Nitric Oxide Metabolomics Facility, Translational Research Core Laboratory, Immunology and Flow Cytometry Core Laboratory) the PTRC Translation Core supports resources for both clinical and translational research and promotes collaborative research and partnerships. Biometrics Core: The PTRC Biometrics Core serves as a central resource providing biostatistical expertise to improve the conception, design, and analysis of pulmonary research studies. The Biometrics Core offers researchers with the consultation with the Core biostatistician for assistance with study planning and helps to design high-impact and scientifically sound research studies. The PTRC Biometrics Core provides assistance in sample size and power calculations, development of analytical plans, data management, and statistical analysis. Regulatory Core: The PTRC Regulatory Core aims to help investigators and their study team in the Division of PACCM with translational and clinical research projects in dealing with the complexities of research regulatory compliance in order to minimize their efforts and facilitate success throughout the lifetime of their research projects. A major emphasis of the PTRC Regulatory Core is to enrich the capabilities of investigators and the study team, and provide them with insight and skills pertinent to regulatory aspects of clinical and translational research. The consultations and activities offered aimed to help ensure compliance with FDA, federal, state, local and industry guidelines and regulations. Clinical Research Core: The mission of the PTRC Clinical Research Core is to serve as a Division resource to provide infrastructure and services including nursing support and specimen collection and processing for investigators who conduct human research studies. The PTRC offers experienced and dedicated research staff to work with investigators throughout the study to optimize and facilitate the research protocols. All PTRC research staff are highly trained in 15 conducting clinical trials that comply with all Federal, State and GCP/ICH guidelines, thus ensuring the collection of exceptional quality data, safety of volunteer subjects and superior care. In collaborating with the Clinical and Translational Science Institute (CTSI) at the University of Pittsburgh, the PTRC Clinical Research Core supports and facilities the conduct of a variety of inpatient and outpatient clinical research studies in pulmonary hypertension, HIV lung research, vascular biology, transplantation immunology, acute lung injury, interstitial lung disease, sleep medicine, cystic fibrosis and host defense, emphysema, asthma and allergy.