2.50
Hdl Handle:
http://hdl.handle.net/10755/165079
Category:
Abstract
Type:
Presentation
Title:
DEVELOPING ELECTRONIC CASE REPORT FORMS WHILE ESTABLISHING STANDARDS
Author(s):
Ness, Elizabeth; Reeves, Dianne
Author Details:
Elizabeth Ness, RN MS, Director, Staff Development, National Cancer Institute, Bethesda, Maryland, USA, email: nesse@mail.nih.gov; Dianne Reeves, RN, MSN, National Cancer Institute, Rockville, Maryland
Abstract:
As a result of shrinking resources for the initiation and conduct of clinical trials, establishing strategies to maximize reuse of data collection tools becomes vital. Creating a data collection tool [i.e.: case report forms (CRFs)] that can be quickly and systematically created and cloned is paramount. The eCRF ideally captures protocol-specific data in a manner to support the needs of the PI, institution, sponsor, and other regulatory/ reporting groups. The use of controlled vocabularies to create metadata that defines the data collected needs to be available. In 2002, the Center for Cancer Research (CCR) initiated a partnership with the National Cancer Institute Center for Bioinformatics (NCICB) to develop a single research database built according to best practices that could also maintain data from multiple disparate legacy databases. The database is called C3D - Cancer Clinical Centralized Database. Central to the successful development of the new database is the development of standard template electronic case report forms (e-CRF). Each field within the eCRF is identified against common data elements (CDEs). If no CDE exists, curation of new CDEs within Cancer Data Standards Repository (caDSR) is completed. Finally, eCRFs, related instructions, and validation/derivation rules are developed. There are various stakeholders involved in the process and oversight is done by the CCR Configuration Control Management Group (CCMG). C3D has over 125 clinical trials built with 90% of these having active data collection and reporting to various sponsors including both industry and government. caBIG adopters of the C3D templates in caDSR have been able to use up to more than 90% of existing content. There have been a number of lessons learned including the need to educate all stake holders about clinical trials and informatics. The implications for the future include applying these processes, standards and infrastructure to the caBIG community and other groups including ONS. ONS can apply these results for their own research such as evidence-based practice research looking at symptom control/ amelioration/measurement. Extension of CCR CCMG model to the caBIG community, with membership of CCR CCMG in the caBIG structure to harmonize business rules, workflow, strategies.
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.titleDEVELOPING ELECTRONIC CASE REPORT FORMS WHILE ESTABLISHING STANDARDSen_GB
dc.contributor.authorNess, Elizabethen_US
dc.contributor.authorReeves, Dianneen_US
dc.author.detailsElizabeth Ness, RN MS, Director, Staff Development, National Cancer Institute, Bethesda, Maryland, USA, email: nesse@mail.nih.gov; Dianne Reeves, RN, MSN, National Cancer Institute, Rockville, Marylanden_US
dc.identifier.urihttp://hdl.handle.net/10755/165079-
dc.description.abstractAs a result of shrinking resources for the initiation and conduct of clinical trials, establishing strategies to maximize reuse of data collection tools becomes vital. Creating a data collection tool [i.e.: case report forms (CRFs)] that can be quickly and systematically created and cloned is paramount. The eCRF ideally captures protocol-specific data in a manner to support the needs of the PI, institution, sponsor, and other regulatory/ reporting groups. The use of controlled vocabularies to create metadata that defines the data collected needs to be available. In 2002, the Center for Cancer Research (CCR) initiated a partnership with the National Cancer Institute Center for Bioinformatics (NCICB) to develop a single research database built according to best practices that could also maintain data from multiple disparate legacy databases. The database is called C3D - Cancer Clinical Centralized Database. Central to the successful development of the new database is the development of standard template electronic case report forms (e-CRF). Each field within the eCRF is identified against common data elements (CDEs). If no CDE exists, curation of new CDEs within Cancer Data Standards Repository (caDSR) is completed. Finally, eCRFs, related instructions, and validation/derivation rules are developed. There are various stakeholders involved in the process and oversight is done by the CCR Configuration Control Management Group (CCMG). C3D has over 125 clinical trials built with 90% of these having active data collection and reporting to various sponsors including both industry and government. caBIG adopters of the C3D templates in caDSR have been able to use up to more than 90% of existing content. There have been a number of lessons learned including the need to educate all stake holders about clinical trials and informatics. The implications for the future include applying these processes, standards and infrastructure to the caBIG community and other groups including ONS. ONS can apply these results for their own research such as evidence-based practice research looking at symptom control/ amelioration/measurement. Extension of CCR CCMG model to the caBIG community, with membership of CCR CCMG in the caBIG structure to harmonize business rules, workflow, strategies.en_GB
dc.date.available2011-10-27T12:12:09Z-
dc.date.issued2011-10-27en_GB
dc.date.accessioned2011-10-27T12:12:09Z-
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.-
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