We use a risk-based system for monitoring clinical studies, improving efficiency as well as patient safety. This method utilizes a combination of central monitoring and on-site monitoring, and focuses on the most critical monitoring activities for enhancing patient safety and ensuring quality data in a particular study. Development of a clinical monitoring plan and an ongoing assessment of risks to patient safety and data quality are important components of our approach to risk-based monitoring.
Once health outcomes are classified by a team of nurse-abstractors and specialty physicians, our biostatistics and statistical computing groups summarize them to provide validated data for use in publications or reports.
The CSCC offers extensive services in creating training materials, manual of procedures, forms and question by question documentation, and planning and hosting training events. We work together with sites and clinical coordinating centers to ensure that the protocol is rigorously followed by the sites and that data is correct entered. Experienced members of our data management, statistical computing and research teams are on hand to provide you with the level of instruction needed to guarantee quality data collection for your research.
We work with study investigators to develop questionnaires and interviews with the goal of high quality data collection, as well as ease of use. We then design data entry screens from the paper instruments that include data validation, automatic skip patterns, and calculations, as needed.
CDART is CSCC's comprehensive research data management solution. Combining knowledge from our decades of experience with electronic data collection with enterprise-scale technologies, CDART provides fully-paperless data acquisition, industry-leading validation, simple extraction, and powerful reporting.
CSCC uses the Qualtrics Research Suite when projects require self-administered survey data capture via mobile devices.
- In order to assure adherence to protocols, the Coordinating Center organizes training of field center staff. CSCC conducts central training sessions prior to the start of study enrollment as well as having considerable expertise in laboratory quality control.