Course

Clinical Trials Data Management and Quality Assurance

Johns Hopkins University

In Clinical Trials Data Management and Quality Assurance, you’ll delve into the meticulous processes of collecting, managing, and safeguarding clinical trial data. The course encompasses the careful selection of data collection instruments, data assembly, statistical performance monitoring, intervention management, and quality assurance protocols.

Throughout the course, you will learn how to handle various aspects of data management, including data integrity, cleaning, and de-identification. Additionally, you will explore the critical stages of trial performance monitoring and intervention management, ensuring the integrity and quality of the trial data.

  • Learn to select and utilize appropriate data collection instruments and database systems.
  • Understand the principles of data assembly, distribution, and de-identification.
  • Discover strategies for conducting statistical performance monitoring and managing treatment interventions.
  • Implement quality assurance protocols to ensure the accuracy and integrity of clinical trial data.

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Clinical Trials Data Management and Quality Assurance
Course Modules

Delve into the intricacies of data collection instruments, data management, assembly and distribution, performance monitoring, intervention management, and quality assurance protocols in this comprehensive course from Johns Hopkins University.

Data Collection Instruments

Explore the fundamental aspects of data collection instruments, encompassing definitions, design considerations, interactions with database systems, and revision protocols.

Data Management

Gain insights into data management principles, including database systems, Excel usage, external data handling, data integrity, and overall data management processes.

Data Assembly and Distribution

Learn about critical stages such as data freeze, data cleaning, de-identification, data sharing, and adherence to data standards in the context of data assembly and distribution.

Performance Monitoring

Discover the importance of performance monitoring throughout different trial stages, site visits, and overall trial performance assessment.

Intervention Management

Understand the principles and examples of managing treatment interventions, including masking interventions, managing treatment supplies, and ensuring intervention integrity.

Quality Assurance

Master the implementation of quality assurance protocols across trial design, preparation, execution, and conclusion phases, ensuring trial data accuracy and integrity.

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