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摘要
Background Case report forms (CRFs) are used to collect data in clinical research. Case report form development represents a significant part of the clinical trial process and can affect study success. Libraries of CRFs can preserve the organizational knowledge and expertise invested in CRF development and expedite the sharing of such knowledge. Although CRF libraries have been advocated, there have been no published accounts reporting institutional experiences with creating and using them. Purpose We sought to enhance an existing institutional CRF library by improving information indexing and accessibility. We describe this CRF library and discuss challenges encountered in its development and implementation, as well as future directions for continued work in this area.
Purpose We sought to enhance an existing institutional CRF library by improving information indexing and accessibility. We describe this CRF library and discuss challenges encountered in its development and implementation, as well as future directions for continued work in this area.
Methods We transformed an existing but underused and poorly accessible CRF library into a resource capable of supporting and expediting clinical and translational investigation at our institution by (1) expanding access to the entire institution; (2) adding more form attributes for improved information retrieval; and (3) creating a formal information curation and maintenance process. An open-source content management system, Plone (Plone.org), served as the platform for our CRF library.
Results We report results from these three processes. Over the course of this project, the size of the CRF library increased from 160 CRFs comprising an estimated total of 17,000 pages, to 177 CRFs totaling 1.5 gigabytes. Eighty-two of these CRFs are now available to researchers across our institution; 95 CRFs remain within a contractual confidentiality window (usually 5 years from database lock) and are not available to users outside of the Duke Clinical Research Institute (DCRI). Conservative estimates suggest that the library supports an average of 37 investigators per month. The resources needed to curate and maintain the CRF library require less than 10% of the effort of one full-time equivalent employee.
Limitations Although we succeeded in expanding use of the CRF library, creating awareness of such institutional resources among investigators and research teams remains challenging and requires additional efforts to overcome. Institutions that have not achieved a critical mass of attractive research resources or effective dissemination mechanisms may encounter persistent difficulty attracting researchers to use institutional resources. Further, a useful CRF library requires both an initial investment of resources for development, as well as ongoing maintenance once it is established.
Conclusions CRF libraries can be established and made broadly available to institutional researchers. Curation - that is, indexing newly added forms - is required. Such a resource provides knowledge management capacity for institutions until standards and software are available to support widespread exchange of data and form definitions. Clinical Trials 2011; 8: 94-102. http://ctj.sagepub.com.
- 出版日期2011-2
