Data Coordination

The Center for Clinical Trials & Data Coordination (CCDC) specializes in clinical trial design, conduct, coordination, and analysis and utilizes the data management and biostatistical infrastructure of the CRHC-DC.

Center for Clinical Trials and Data Coordination (CCDC)

The Center for Clinical Trials and Data Coordination (CCDC) aims to be a national leader in the design, conduct, coordination, and analysis of clinical trials. Established in 2015, the CCDC guides clinical trials from conception to closeout, employing a system that seamlessly integrates critical elements of clinical trial management including: electronic data capture, eligibility & randomization, drug & external data tracking, safety reporting, outcome adjudication, data & safety monitoring, statistical analysis & reporting, data sharing, and regulatory compliance. The CCDC uses clinical research data coordinators who function as conduits between the clinical, data, and statistical teams of each study. The coordinators oversee protocol development & training, on-site and centralized study monitoring, safety reporting, and regulatory compliance. This alleviates the burden on the clinical side of the study, thereby facilitating more timely data analysis, publication, and data sharing. Its emphasis on standardization and streamlining, combined with the established statistical analysis and data management infrastructure of the Center for Research on Heath Care Data Center, makes the CCDC the preeminent place for comprehensive clinical trials-related support.

Capabilities

The Center for Clinical Trials and Data Coordination (CCDC) provides comprehensive clinical trial management support for clinical trials. We have expertise in biostatistics, data management, and study coordination.

Biostatistics

The CCDC partners with the Center for Research on Health Care (CRHC) Data Center Biostatistics Core to provide expertise in the development and execution of statistical analysis plans. The Core also includes MS and BS-level statisticians who contribute significantly to developing and conducting analyses as well as interpreting and writing for publications and grant applications. The Core statisticians also have experience implementing data sharing plans with numerous NIH data repositories.

Data Management

We work with the CRHC Data Center Data Management Core to implement state of the art data management systems that can be accessed from any electronic device. Each data management system is designed to facilitate the workflow of the study. We work with the investigative team to develop the case report form and an integrated tracking system. Our data management systems have the capability to incorporate electronic health record data and are developed using .NET to create the interface and SQL Server for the database.

Our team can create a data management system that is compliant with current data security practices, including FDA's Title 21 CFR Part 11 federal regulations.

Study Coordination

The CCDC utilizes clinical research data coordinators who function as conduits between the clinical, data, and statistical teams of each study. They develop, implement, and oversee study-specific procedures for:

  • Protocol development & training
  • On-site and centralized study monitoring
  • Safety reporting
  • Regulatory compliance

electronic Trial Management System (eTMS)

Projects & Collaborations

Project List