A Clinical Data Management System for Diabetes Clinical Trials

Area of Science:

• Biomedical Informatics
• Clinical Research Management
• Diabetes Mellitus Research

Background:

• Diabetes clinical trials are essential for validating novel treatments and management strategies.
• Effective data management is crucial for the integrity and success of these trials.
• Current data management practices may not fully leverage technological advancements.

Purpose of the Study:

• To develop a comprehensive web-based data management system tailored for diabetes clinical trials.
• To enhance the efficiency and reliability of data collection and handling in diabetes research.

Main Methods:

• A mixed-methods approach was employed in 2019.
• Questionnaires from 60 researchers identified essential data elements and system functions.
• Usability and functional evaluations involved 6 and 30 researchers, respectively, using think-aloud and questionnaire methods.

Main Results:

• Key data elements identified include study, participant personal, and clinical data.
• Essential system functions encompass study management, case report form creation, data management, quality control, and security.
• Researchers rated the system's functions positively (6.3/7) post-evaluation.

Conclusions:

• Web-based clinical data management systems are vital for modern diabetes clinical trials.
• The developed system offers significant improvements in creating and managing case report forms and collecting data.
• This technology facilitates more efficient and secure data handling in diabetes research.