e17512 Background: Oncology clinical research can be facilitated through use of a set of core variables to collect, aggregate, analyze and report data across a number of diverse research settings. These elements can be captured in Case Report Form (CRF) templates, and cloned to expedite the activation of a clinical trial and the collection of data. Through the efforts of the Cancer Biomedical Informatics Grid or caBIG community, the creation of a set of CRFs to support NCI-sponsored trials has been underway since the summer of 2007. Methods: A schematic to represent commonly-used CRFs in oncology trials was created as a roadmap for the project. Priorities were established, and community broadcasts used to recruit workgroup members with clinical, biostatistical, and regulatory expertise. CRFs were contributed by the community-at-large, including the pharmaceutical industry and NCI cooperative groups. Variables from a set of CRFs were partitioned into one of four groups: mandatory, conditional, optional, or not to be included in a CRF. After all the variables for a CRF were finalized by consensus, data elements were created and registered into an NCI ISO/IEC 11179 metadata repository that facilitates the reuse of data elements and CRFs. Results: Eight workgroups have completed their work by the end of 2008, with additional groups underway. The results of the first eight groups were harmonized with the Clinical Data Acquisitions Standards Harmonization or CDASH version 1.0, a standard for CDISC. After approval, the variables are assembled into CRFs with instructions that are available through NCI's data standards repository in a variety of electronic formats. The variables will undergo a rigorous change management process with regular review and versioning as required. Conclusions: The identification and reuse of standards to support the conduct of oncology research depends upon our ability to manage data sets that can be aggregated and analyzed in a timely manner. The caBIG CRF harmonization and standardization variables are being implemented now through a series of early adoption activities and a phased deployment plan that will result in the reuse of a single set of variables to support the conduct of oncology clinical trials. No significant financial relationships to disclose.
Case Report Form (CRF) Design Made Easy: An Evaluation of Clinical Data Acquisition Standards Harmonization (CDASH) in Use