Data Management

Many granting agencies now require the use of Data Coordinating Centers (DCC) as part of granted multi-center trials.  DCCs can play a vital role in the planning and implementation of a large trial. The role of the DCC is based on the needs of each project but may include the following activities:

  • Manual of Procedures composition and maintenance
  • Regulatory oversight
  • Randomization development and management
  • Case Report Form (CRF) development
  • Database development
  • Data handling and quality assurance
  • Statistical analysis
  • Training site personnel on CRF completion
  • Participation on various trial committees
  • Production of reports for DSMB and Executive Committees
  • Continued training of new personnel either by in-person visit or teleconference
  • Clarifying the roles and responsibilities of all stakeholders involved in clinical trials
  • Forming and maintaining successful working relationships with investigators and IRBs
  • Implementing effective data and safety monitoring measures
  • Managing study sites and conducting monitoring visits

Data coordination is crucial for the success of a clinical trial. Trials that are not tightly controlled result in cost overruns. Over the years, CTU has developed procedures and controls to ensure that trials are brought to completion successfully. CTU is experienced in the following activities to manage multi-center trials:

  • Defining enrollment strategies to minimize costs and stay on budget
  • Leading the clinical trial teams and organizing effective team meetings to model good communication practices throughout the trial
  • Utilizing proven audit techniques to establish a practical approach for maintaining regulatory compliance
  • Implementing best practices for managing misconduct and fraud to protect patient safety and avoid costly regulatory and legal action
  • Developing efficient processes for data management and adverse event reporting to streamline compliance requirements
  • Utilizing quality control tools to collect and measure performance data
  • Implementing process improvements

Email CTU for more information.