grant boilerplate language - PACCM @ Pitt

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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.
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