Description
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.
Objectives
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.
Objectives
- 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