The Clinical Operations and Regulatory Affairs (CORA) Core provides the Weill Cornell four COPD SCCOR clinical projects the infrastructure and expertise to conduct clinical research projects that follow the regulations and guidelines of the Food and Drug Administration (FDA), National Institutes of Health (NIH), Institutional Review Board (IRB) and Office for Human Research protections (OHRP). Included in the CORA Core are four components: (1) Clinical Operations;(2) Regulatory Affairs;(3) Monitoring;and (4) Data Management and Analysis. The Clinical Operation component is the major interface of the CORA Core with the study participants and investigators, providing services to carry out the clinical study in compliance with all regulations and guidelines under established standard operating procedures. The Clinical Operation component is also the major interface between the investigators and the local oversight groups, including the IRB and the General Clinical Research Center (GCRC). The Monitoring component functions to verify that all functions of the CORA Core are appropriate. The Data Management and Analysis component processes collected and verified data, enters the data into databases, and analyzes the data using appropriate statistical methods. The Regulatory Affairs component is the interface of the CORA Core with federal agencies for oversight of clinical research studies. In addition the Regulatory Affairs component provides periodic reports to the Weill Cornell Data Safety and Monitoring Board to provide additional oversight to clinical studies. The CORA Core also participates in the Weill Cornell COPD SCCOR Clinical Research Skills Development Core (Core E), providing training in Clinical Operations/Regulatory Affairs. The CORA Core will play an important role in helping the investigators to implement and conduct the four clinical projects. Finally, the CORA Core will play a central role in assisting the investigators in preparing, submitting and getting all regulatory documents to the IRB and the Weill Cornell Data Safety Monitoring Board (DSMB) throughout the yr 01-05 study period.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Specialized Center (P50)
Project #
Application #
Study Section
Special Emphasis Panel (ZHL1)
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Weill Medical College of Cornell University
New York
United States
Zip Code
Strulovici-Barel, Yael; Staudt, Michelle R; Krause, Anja et al. (2016) Persistence of circulating endothelial microparticles in COPD despite smoking cessation. Thorax 71:1137-1144
Barjaktarevic, Igor Z; Crystal, Ronald G; Kaner, Robert J (2016) The Role of Interleukin-23 in the Early Development of Emphysema in HIV1(+) Smokers. J Immunol Res 2016:3463104
Harvey, Ben-Gary; Strulovici-Barel, Yael; Kaner, Robert J et al. (2015) Risk of COPD with obstruction in active smokers with normal spirometry and reduced diffusion capacity. Eur Respir J 46:1589-1597
Gomi, Kazunori; Arbelaez, Vanessa; Crystal, Ronald G et al. (2015) Activation of NOTCH1 or NOTCH3 signaling skews human airway basal cell differentiation toward a secretory pathway. PLoS One 10:e0116507
Wang, Guoqing; Wang, Rui; Strulovici-Barel, Yael et al. (2015) Persistence of smoking-induced dysregulation of miRNA expression in the small airway epithelium despite smoking cessation. PLoS One 10:e0120824
Walters, Matthew S; De, Bishnu P; Salit, Jacqueline et al. (2014) Smoking accelerates aging of the small airway epithelium. Respir Res 15:94
Hessel, Justina; Heldrich, Jonna; Fuller, Jennifer et al. (2014) Intraflagellar transport gene expression associated with short cilia in smoking and COPD. PLoS One 9:e85453
Shaykhiev, Renat; Crystal, Ronald G (2014) Early events in the pathogenesis of chronic obstructive pulmonary disease. Smoking-induced reprogramming of airway epithelial basal progenitor cells. Ann Am Thorac Soc 11 Suppl 5:S252-8
Brekman, Angelika; Walters, Matthew S; Tilley, Ann E et al. (2014) FOXJ1 prevents cilia growth inhibition by cigarette smoke in human airway epithelium in vitro. Am J Respir Cell Mol Biol 51:688-700
Gao, Chuan; Tignor, Nicole L; Salit, Jacqueline et al. (2014) HEFT: eQTL analysis of many thousands of expressed genes while simultaneously controlling for hidden factors. Bioinformatics 30:369-76

Showing the most recent 10 out of 75 publications