Creation of Harmonized Case Report Forms (CRFs) and Variables to Facilitate Data Collection and Research

2.50
Hdl Handle:
http://hdl.handle.net/10755/164794
Category:
Abstract
Type:
Presentation
Title:
Creation of Harmonized Case Report Forms (CRFs) and Variables to Facilitate Data Collection and Research
Author(s):
Reeves, Dianne; Ness, Elizabeth
Author Details:
Dianne Reeves, RN, Associate Director Biomedical Data Standards, National Cancer Institute CBIIT, Rockville, Maryland, USA, email: reevesd@mail.nih.gov; Elizabeth Ness, RN, MS, National Cancer Institute, Bethesda, Maryland
Abstract:
Clinical/Evidence Based Practice: As cited in the Oncology Nursing Society's Manual for Clinical Trials Nursing (second edition) of 2008, there is a critical connection between advancements in cancer detection, prevention, and treatment, and data collected in clinical trials. Oncology research is enhanced through the use of a set of standard variables to collect, aggregate, analyze and report data. These elements populate Case Report Form (CRFs) that can be cloned to expedite clinical trial activation and data collection. The purpose of this abstract is to share the process and outcomes to date of the cancer clinical research community efforts in achieving harmonized CRFs. Through the work of the Cancer Biomedical Informatics Grid (caBIG) community, the creation of a portfolio of CRFs for NCIsponsored trials has been underway since mid-2007. CRF priorities were established, and community broadcasts used to recruit workgroup members with clinical, biostatistical, and regulatory expertise. Existing CRFs were contributed by the community, including the pharmaceutical industry. Variables from a group of CRFs were partitioned into one of four groups: mandatory, conditional, optional, or not included in a CRF. After all variables for a CRF were finalized by consensus, data elements were created and registered in an NCI repository. Eight workgroups have completed their work, with additional groups now underway. The results of the first eight groups were harmonized with data collection standards from Clinical Data Interchange Standards Consortium (CDISC) and other groups. After approval, the variables are assembled into CRFs (and completion instructions) available through NCI repository in a variety of electronic formats. The variables will undergo a rigorous change management process with regular review periods stipulated. Identification and reuse of standards will enhance our ability to collect, analyze, manage, and improve the quality of data. Harmonized variables are being implemented now through a series of caBIG early adoption activities and a phased deployment plan that will result in the ability to reuse of a single set of variables to support clinical trial data collection and management. Our Nursing Research and Clinical Trials Nursing communities will benefit through an awareness and application of these efforts.
Repository Posting Date:
27-Oct-2011
Date of Publication:
27-Oct-2011
Conference Date:
2009
Conference Name:
34th Annual Oncology Nursing Society Congress
Conference Host:
Oncology Nursing Society
Conference Location:
San Antonio, Texas, 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.titleCreation of Harmonized Case Report Forms (CRFs) and Variables to Facilitate Data Collection and Researchen_GB
dc.contributor.authorReeves, Dianneen_US
dc.contributor.authorNess, Elizabethen_US
dc.author.detailsDianne Reeves, RN, Associate Director Biomedical Data Standards, National Cancer Institute CBIIT, Rockville, Maryland, USA, email: reevesd@mail.nih.gov; Elizabeth Ness, RN, MS, National Cancer Institute, Bethesda, Marylanden_US
dc.identifier.urihttp://hdl.handle.net/10755/164794-
dc.description.abstractClinical/Evidence Based Practice: As cited in the Oncology Nursing Society's Manual for Clinical Trials Nursing (second edition) of 2008, there is a critical connection between advancements in cancer detection, prevention, and treatment, and data collected in clinical trials. Oncology research is enhanced through the use of a set of standard variables to collect, aggregate, analyze and report data. These elements populate Case Report Form (CRFs) that can be cloned to expedite clinical trial activation and data collection. The purpose of this abstract is to share the process and outcomes to date of the cancer clinical research community efforts in achieving harmonized CRFs. Through the work of the Cancer Biomedical Informatics Grid (caBIG) community, the creation of a portfolio of CRFs for NCIsponsored trials has been underway since mid-2007. CRF priorities were established, and community broadcasts used to recruit workgroup members with clinical, biostatistical, and regulatory expertise. Existing CRFs were contributed by the community, including the pharmaceutical industry. Variables from a group of CRFs were partitioned into one of four groups: mandatory, conditional, optional, or not included in a CRF. After all variables for a CRF were finalized by consensus, data elements were created and registered in an NCI repository. Eight workgroups have completed their work, with additional groups now underway. The results of the first eight groups were harmonized with data collection standards from Clinical Data Interchange Standards Consortium (CDISC) and other groups. After approval, the variables are assembled into CRFs (and completion instructions) available through NCI repository in a variety of electronic formats. The variables will undergo a rigorous change management process with regular review periods stipulated. Identification and reuse of standards will enhance our ability to collect, analyze, manage, and improve the quality of data. Harmonized variables are being implemented now through a series of caBIG early adoption activities and a phased deployment plan that will result in the ability to reuse of a single set of variables to support clinical trial data collection and management. Our Nursing Research and Clinical Trials Nursing communities will benefit through an awareness and application of these efforts.en_GB
dc.date.available2011-10-27T12:07:07Z-
dc.date.issued2011-10-27en_GB
dc.date.accessioned2011-10-27T12:07:07Z-
dc.conference.date2009en_US
dc.conference.name34th Annual Oncology Nursing Society Congressen_US
dc.conference.hostOncology Nursing Societyen_US
dc.conference.locationSan Antonio, Texas, 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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