The DCRC Data Core (DC) serves as the Center's resource for providing Data Management, Data Quality Assurance, Data Processing, and Statistical Analysis for the DCRC. The DC will be housed at Bastyr University under the direction of Annette Fitzpatrick Ph.D. who will work closely with the other DCRC project leaders in ensuring that all clinical data collection, management and analysis processes are of the highest quality. The DC will develop and implement Standard Operating Procedures for all data collection and management activities and will provide quality assurance and control activities. The DC will also support Dr. Standish in developing a Data Safety Monitoring Plan for the Dose Escalation trial planned for Project 3. Data for reports to the Internal and External Advisory Committees, the IRBs of the participating institutions and NCCAM will be the responsibility of the DC. Analysis of data for publications and future grant applications will also be conducted by the DC. Both the DCRC and its component projects will benefit from the services provided by the DC from project initiation with the development of data collection tools and study databases through project completion with reports to be used in manuscript development and future study designs.
