An Innovative, Web-Based Reporting System for Serious Adverse Events Developed by the Cancer Therapy Evaluation Program (CTEP), National Cancer Institute (NCI)

2.50
Hdl Handle:
http://hdl.handle.net/10755/164625
Category:
Abstract
Type:
Presentation
Title:
An Innovative, Web-Based Reporting System for Serious Adverse Events Developed by the Cancer Therapy Evaluation Program (CTEP), National Cancer Institute (NCI)
Author(s):
Setser, Ann
Author Details:
Ann Setser, National Cancer Institute, Bethesda, Maryland, USA
Abstract:
AdEERS (Adverse Event Expedited Reporting System) is one of the NCI's initiatives to apply advances in information technology to the area of safety surveillance for patients enrolled on clinical trials. AdEERS is a web-based system that utilizes the NCI CTC v2.0 (Common Toxicity Criteria) for submission of serious adverse events. NCI published the expanded CTC in 1998 and, in compliance with the International Conference on Harmonization (ICH), mapped adverse event terms to MedDRA (Medical Dictionary for Regulatory Affairs). MedDRA is the new global standard medical terminology to facilitate research and safety monitoring and to make the regulatory approval process more efficient and responsive. AdEERS is designed to support the classification, retrieval, and evaluation of adverse event information using MedDRA adverse event terms, disease names, prior therapies, and pre-existing conditions. The first version of AdEERS was released last year. Nurses at select cancer centers and cooperative groups participated in testing the beta version of AdEERS last year. Their experience provided valuable enhancements for the current version of AdEERS (released January 1, 2001) being used by all NCI collaborators. The goal of AdEERS, to increase the efficiency, completeness, and accuracy of safety monitoring and reporting to the Food and Drug Administration (FDA), was rapidly recognized. In the first six months, 1,800 reports were submitted providing real-time reporting and assessment of serious adverse events. AdEERS allows for rapid retrieval and dissemination of information, especially trends in adverse events that effect patient safety. AdEERS is a secure site using 128-bit data encryption that can be accessed using an industry standard browser. An AdEERS training site and computer based training are available on the NCI website.
Repository Posting Date:
27-Oct-2011
Date of Publication:
27-Oct-2011
Conference Date:
2002
Conference Name:
27th Annual Oncology Nursing Society Congress
Conference Host:
Oncology Nursing Society
Conference Location:
Washington, D.C., 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.titleAn Innovative, Web-Based Reporting System for Serious Adverse Events Developed by the Cancer Therapy Evaluation Program (CTEP), National Cancer Institute (NCI)en_GB
dc.contributor.authorSetser, Annen_US
dc.author.detailsAnn Setser, National Cancer Institute, Bethesda, Maryland, USAen_US
dc.identifier.urihttp://hdl.handle.net/10755/164625-
dc.description.abstractAdEERS (Adverse Event Expedited Reporting System) is one of the NCI's initiatives to apply advances in information technology to the area of safety surveillance for patients enrolled on clinical trials. AdEERS is a web-based system that utilizes the NCI CTC v2.0 (Common Toxicity Criteria) for submission of serious adverse events. NCI published the expanded CTC in 1998 and, in compliance with the International Conference on Harmonization (ICH), mapped adverse event terms to MedDRA (Medical Dictionary for Regulatory Affairs). MedDRA is the new global standard medical terminology to facilitate research and safety monitoring and to make the regulatory approval process more efficient and responsive. AdEERS is designed to support the classification, retrieval, and evaluation of adverse event information using MedDRA adverse event terms, disease names, prior therapies, and pre-existing conditions. The first version of AdEERS was released last year. Nurses at select cancer centers and cooperative groups participated in testing the beta version of AdEERS last year. Their experience provided valuable enhancements for the current version of AdEERS (released January 1, 2001) being used by all NCI collaborators. The goal of AdEERS, to increase the efficiency, completeness, and accuracy of safety monitoring and reporting to the Food and Drug Administration (FDA), was rapidly recognized. In the first six months, 1,800 reports were submitted providing real-time reporting and assessment of serious adverse events. AdEERS allows for rapid retrieval and dissemination of information, especially trends in adverse events that effect patient safety. AdEERS is a secure site using 128-bit data encryption that can be accessed using an industry standard browser. An AdEERS training site and computer based training are available on the NCI website.en_GB
dc.date.available2011-10-27T12:04:06Z-
dc.date.issued2011-10-27en_GB
dc.date.accessioned2011-10-27T12:04:06Z-
dc.conference.date2002en_US
dc.conference.name27th Annual Oncology Nursing Society Congressen_US
dc.conference.hostOncology Nursing Societyen_US
dc.conference.locationWashington, D.C., 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.-
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