2.50
Hdl Handle:
http://hdl.handle.net/10755/164721
Category:
Abstract
Type:
Presentation
Title:
DEVELOPMENT OF A CLINICAL TRIAL TRACKING TOOL
Author(s):
Lesko, Zenona; Gaynes, Lisa; Scagliola, Joan; Utate, Minerva; Catamero, Donna; Morillo, Alexi; Escalon, Juliet
Author Details:
Zenona Lesko, RN, Clinical Research Nurse Coordinator, NYU Cancer Institute, New York, New York, USA, email: zenona.lesko@med.nyu.edu; Lisa Gaynes, BS; Joan Scagliola, MSN; Minerva Utate, RN, BSN, OCN; Donna Catamero, RN, BSN, OCN, CCRC; Alexi Morillo, BS; Juliet Escalon, RN, OCN, ANP, CCRC
Abstract:
A specialized research team is integral to the successful implementation of a clinical trial (CT) program. A cancer institute that is partnered with hospital and ambulatory clinical care provides the opportunity to offer innovative scientific and disease focused research programs. The increasing number of complex CTs presents challenges that are coupled with increasing regulatory requirements and economic constraints. Collaborating with all members of the interdisciplinary team is key to achieving a successful CT program. A task force was organized to develop a CT tracking tool that describes all elements of a clinical trial, and identify the members of the interdisciplinary team who are accountable for each element. The purpose of the tool was to clarify each memberÆs role and promote utilization of essential team memberÆs skills and knowledge in order to decrease duplication of effort and increase communication among the interdisciplinary team. A CT tracking tool that includes elements of a clinical trial including protocol pre-activation, screening, eligibility, informed consent, active treatment, regulatory/ economic components, quality improvement, patient tracking and reporting was developed. Included in this tool is a column indicating responsible individual (principal investigator, research RN, infusion RN, data management, regulatory, pharmacy, lab, and clinical trials office). Nurse to clinical trial ratio based on complexity and nursing time was defined. A weekly CT interdisciplinary feasibility meeting was organized to ensure that resources needed to address the above listed CT elements were available prior to a trail going to the IRB. The CT team has a streamlined system that facilitates the flow of the trials demonstrated by less time spent in trouble shooting after a trail has been approved. Transparency regarding work load and need for cross coverage was established. Regulatory and financial documentation have improved while enrollment to clinical trials continues to steadily increase. Including stakeholders in the development and implementation of the CT tracking tool successfully fostered partnerships among members of the research program.
Repository Posting Date:
27-Oct-2011
Date of Publication:
27-Oct-2011
Conference Date:
2007
Conference Name:
32nd Annual Oncology Nursing Society Congress
Conference Host:
Oncology Nursing Society
Conference Location:
Las Vegas, Nevada, USA
Note:
This is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.

Full metadata record

DC FieldValue Language
dc.type.categoryAbstracten_US
dc.typePresentationen_GB
dc.titleDEVELOPMENT OF A CLINICAL TRIAL TRACKING TOOLen_GB
dc.contributor.authorLesko, Zenonaen_US
dc.contributor.authorGaynes, Lisaen_US
dc.contributor.authorScagliola, Joanen_US
dc.contributor.authorUtate, Minervaen_US
dc.contributor.authorCatamero, Donnaen_US
dc.contributor.authorMorillo, Alexien_US
dc.contributor.authorEscalon, Julieten_US
dc.author.detailsZenona Lesko, RN, Clinical Research Nurse Coordinator, NYU Cancer Institute, New York, New York, USA, email: zenona.lesko@med.nyu.edu; Lisa Gaynes, BS; Joan Scagliola, MSN; Minerva Utate, RN, BSN, OCN; Donna Catamero, RN, BSN, OCN, CCRC; Alexi Morillo, BS; Juliet Escalon, RN, OCN, ANP, CCRCen_US
dc.identifier.urihttp://hdl.handle.net/10755/164721-
dc.description.abstractA specialized research team is integral to the successful implementation of a clinical trial (CT) program. A cancer institute that is partnered with hospital and ambulatory clinical care provides the opportunity to offer innovative scientific and disease focused research programs. The increasing number of complex CTs presents challenges that are coupled with increasing regulatory requirements and economic constraints. Collaborating with all members of the interdisciplinary team is key to achieving a successful CT program. A task force was organized to develop a CT tracking tool that describes all elements of a clinical trial, and identify the members of the interdisciplinary team who are accountable for each element. The purpose of the tool was to clarify each memberÆs role and promote utilization of essential team memberÆs skills and knowledge in order to decrease duplication of effort and increase communication among the interdisciplinary team. A CT tracking tool that includes elements of a clinical trial including protocol pre-activation, screening, eligibility, informed consent, active treatment, regulatory/ economic components, quality improvement, patient tracking and reporting was developed. Included in this tool is a column indicating responsible individual (principal investigator, research RN, infusion RN, data management, regulatory, pharmacy, lab, and clinical trials office). Nurse to clinical trial ratio based on complexity and nursing time was defined. A weekly CT interdisciplinary feasibility meeting was organized to ensure that resources needed to address the above listed CT elements were available prior to a trail going to the IRB. The CT team has a streamlined system that facilitates the flow of the trials demonstrated by less time spent in trouble shooting after a trail has been approved. Transparency regarding work load and need for cross coverage was established. Regulatory and financial documentation have improved while enrollment to clinical trials continues to steadily increase. Including stakeholders in the development and implementation of the CT tracking tool successfully fostered partnerships among members of the research program.en_GB
dc.date.available2011-10-27T12:05:46Z-
dc.date.issued2011-10-27en_GB
dc.date.accessioned2011-10-27T12:05:46Z-
dc.conference.date2007en_US
dc.conference.name32nd Annual Oncology Nursing Society Congressen_US
dc.conference.hostOncology Nursing Societyen_US
dc.conference.locationLas Vegas, Nevada, USAen_US
dc.description.noteThis is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.-
All Items in this repository are protected by copyright, with all rights reserved, unless otherwise indicated.