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Data management procedures in the Asthma Clinical Research Network.
R M Pogash1, S J Boehmer, P E Forand
1Department of Health Evaluation Sciences, College of Medicine, Pennsylvania State University, Hershey, PA 17033, USA.
Controlled Clinical Trials
|December 1, 2001
Summary
Effective data management is crucial for high-quality multicenter clinical trial data. This study details the Asthma Clinical Research Network
Area of Science:
- Clinical Trials
- Data Management
- Health Informatics
Background:
- High-quality data is critical for the success of multicenter clinical trials.
- Robust data management processes are essential to ensure data integrity and reliability.
- The Asthma Clinical Research Network (ACRN) required a comprehensive data management system.
Purpose of the Study:
- To describe the data management processes and systems developed by the ACRN data coordinating center.
- To outline a system for handling clinical trial data from collection through statistical analysis.
- To detail methods for monitoring and reporting data quality in a multicenter setting.
Main Methods:
- Development of a distributed database management system with modular applications.
- Implementation of combined manual and electronic processes for data handling.
- Establishment of procedures for data entry, tracking, verification, validation, and editing.
Main Results:
- A functional data management system was successfully implemented.
- The system integrated manual and electronic components for efficient data processing.
- Processes for continuous data quality monitoring and reporting were established.
Conclusions:
- Well-designed data management is fundamental to ensuring data quality in multicenter clinical trials.
- The described system provides a framework for effective data processing and quality control.
- The ACRN data management approach supports reliable statistical analysis and trial outcomes.
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