We use a combination of risk-based monitoring (RBM) and centralized monitoring (remote data review) approaches with occasional on-site visits for source data review (SDV) in our clinical monitoring. This improves efficiency as well as protects study participants by focusing on the most critical elements of monitoring activities to enhance participant safety and ensure quality of the data collected in our different studies. Early development of a clinical monitoring plan and providing an ongoing assessment of the greatest risks to participant safety help prevent issues before they arise and ensure the highest quality and lowest error rate possible in the data collected.
We can classify medical endpoints for certain studies in a standardized manner with our team of professional nurse-abstractors and specialty physicians who review select data points and confirm actual diagnoses of interest. Both medical research teams are trained, certified and involved in quality control exercises to maintain the skills to do their work with the same approach, preventing possible bias in the data. Our biostatistics and statistical computing groups then summarize the results 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 correctly 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 are also available to offer updates on protocol and procedures at annual meetings as well as training, certification of new staff and re-certification of seasoned staff for quality control throughout the course of our clinical studies.
- 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. Our in-house Form Designing tool is capable of building complex and customizable forms from the paper instruments.
- 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.