Clinical Research Data Management and Technology Implementation


This course focused on the standard operating procedures and best practices of study data capture and management of a regulated clinical trial. The scope of the course involved estimating the budgetary requirements for supporting data management, understanding the complexities involved in the ethical conduct of multi-site data collection and evaluation, developing a data management plan, designing data collection forms and databases, assessing data management tools and trends, and reviewing audit data for continuous quality improvement.

  • Estimate the staff and money required for the data entry, management, and analysis portions of a regulated clinical trial.
  • Evaluate the methods for tracking study participants, reporting sample attrition, and implications for the generalizability of the findings.
  • Synthesize the course content related to forms and database design, clinical data management systems, data quality and security by designing a data management and analysis plan
  • Assess the complexities of ethical data management and integration from multi-site clinical trials domestic and international
  • Summarize the documenting, reporting, and public use dataset requirements for clinical trials