Nursing and Biomedical Engineering Transdisciplinary Clinical Trials Collaboration

2.50
Hdl Handle:
http://hdl.handle.net/10755/149076
Type:
Presentation
Title:
Nursing and Biomedical Engineering Transdisciplinary Clinical Trials Collaboration
Abstract:
Nursing and Biomedical Engineering Transdisciplinary Clinical Trials Collaboration
Conference Sponsor:Sigma Theta Tau International
Conference Year:2003
Author:Mick, Diane J., PhD, RN, CCNS, GNP
P.I. Institution Name:University of Rochester
Title:Assistant Professor of Nursing, Co-Director, Center for Clinical Trials and Medical Device Evaluation
Co-Authors:Michael H. Ackerman, DNS, RN-CS, FCCM, FNAP
The dual goals of clinical trials research are to determine the effectiveness of medical device and/or pharmaceutical interventions and to identify additional explanatory factors related to mechanisms of disease processes. For nurses, at both staff and advanced practice levels, involvement in clinical trials research can be an exciting opportunity to improve health care by moving medical devices and pharmaceuticals from the laboratory to those patients who need them. For biomedical engineering students, participation in medical device start-up design and improvement can be a professionally stimulating point of entry into the world of patient clinical transactions. In this presentation, the directors of the first School of Nursing-based Center for Clinical Trials and Medical Device Evaluation in the United States will articulate nursing's essential contribution to clinical trials research. A description of an innovative transdisciplinary academic relationship between the School of Nursing and the Department of Biomedical Engineering will be used to illustrate the importance of collaboration in the emerging field of clinical trials research, and to demonstrate specialized development opportunities open to health care professionals who are willing to transcend the mold of traditional roles. Via an anecdotal/case study format, foundational elements of clinical trials research, qualifications of investigators and study staff, the role of Institutional Review Boards, study design and logistics, budgets, subject selection, informed consent, subject compliance, and quality improvements and quality control will be described. FDA definitions of pharmaceuticals and medical devices will be provided, and cGMPs (Current Good Manufacturing Practices) will be discussed. Descriptions of research roles for nurses at all levels of practice, as well as portrayals of opportunities for scholarly collaboration with related academic disciplines, will be integrated throughout this discussion. Via examination of the research processes that underlie health improvement, novel career opportunities for provision of high-quality patient care will be identified and explored.
Repository Posting Date:
26-Oct-2011
Date of Publication:
17-Oct-2011
Sponsors:
Sigma Theta Tau International

Full metadata record

DC FieldValue Language
dc.typePresentationen_GB
dc.titleNursing and Biomedical Engineering Transdisciplinary Clinical Trials Collaborationen_GB
dc.identifier.urihttp://hdl.handle.net/10755/149076-
dc.description.abstract<table><tr><td colspan="2" class="item-title">Nursing and Biomedical Engineering Transdisciplinary Clinical Trials Collaboration</td></tr><tr class="item-sponsor"><td class="label">Conference Sponsor:</td><td class="value">Sigma Theta Tau International</td></tr><tr class="item-year"><td class="label">Conference Year:</td><td class="value">2003</td></tr><tr class="item-author"><td class="label">Author:</td><td class="value">Mick, Diane J., PhD, RN, CCNS, GNP</td></tr><tr class="item-institute"><td class="label">P.I. Institution Name:</td><td class="value">University of Rochester</td></tr><tr class="item-author-title"><td class="label">Title:</td><td class="value">Assistant Professor of Nursing, Co-Director, Center for Clinical Trials and Medical Device Evaluation</td></tr><tr class="item-email"><td class="label">Email:</td><td class="value">Diane_Mick@urmc.rochester.edu</td></tr><tr class="item-co-authors"><td class="label">Co-Authors:</td><td class="value">Michael H. Ackerman, DNS, RN-CS, FCCM, FNAP</td></tr><tr><td colspan="2" class="item-abstract">The dual goals of clinical trials research are to determine the effectiveness of medical device and/or pharmaceutical interventions and to identify additional explanatory factors related to mechanisms of disease processes. For nurses, at both staff and advanced practice levels, involvement in clinical trials research can be an exciting opportunity to improve health care by moving medical devices and pharmaceuticals from the laboratory to those patients who need them. For biomedical engineering students, participation in medical device start-up design and improvement can be a professionally stimulating point of entry into the world of patient clinical transactions. In this presentation, the directors of the first School of Nursing-based Center for Clinical Trials and Medical Device Evaluation in the United States will articulate nursing's essential contribution to clinical trials research. A description of an innovative transdisciplinary academic relationship between the School of Nursing and the Department of Biomedical Engineering will be used to illustrate the importance of collaboration in the emerging field of clinical trials research, and to demonstrate specialized development opportunities open to health care professionals who are willing to transcend the mold of traditional roles. Via an anecdotal/case study format, foundational elements of clinical trials research, qualifications of investigators and study staff, the role of Institutional Review Boards, study design and logistics, budgets, subject selection, informed consent, subject compliance, and quality improvements and quality control will be described. FDA definitions of pharmaceuticals and medical devices will be provided, and cGMPs (Current Good Manufacturing Practices) will be discussed. Descriptions of research roles for nurses at all levels of practice, as well as portrayals of opportunities for scholarly collaboration with related academic disciplines, will be integrated throughout this discussion. Via examination of the research processes that underlie health improvement, novel career opportunities for provision of high-quality patient care will be identified and explored.</td></tr></table>en_GB
dc.date.available2011-10-26T09:55:42Z-
dc.date.issued2011-10-17en_GB
dc.date.accessioned2011-10-26T09:55:42Z-
dc.description.sponsorshipSigma Theta Tau Internationalen_GB
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