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.
- Providing you with a flexible data management system customized to you and your study’s needs is what we designed CDART to do best. Tell us what you need, and we can apply CDART to it. CDART (Carolina Data Acquisition and Reporting Tool) is an enterprise-grade, scalable, web-based data management tool made for multi-center clinical trials, observational studies, and patient registries. We’ll work with you to customize the CDART data management system to meet your needs. Instead of changing your study to fit a system, we customize CDART to the needs of your study and your staff.
- 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.