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Managing data in surgical trials: a guide to modern-day data management systems
Paljinder Bhatti1, Emil H Schemitsch, Mohit Bhandari
1Division of Orthopaedic Surgery, Department of Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, Ontario L8L 8E7, Canada.
The Journal of Bone and Joint Surgery. American Volume
|July 20, 2012
Summary
Effective data management, including clinical trial data, relies on organized strategies and technology. Experienced teams and adherence to FDA regulations ensure trustworthy electronic records for successful clinical trial outcomes.
Area of Science:
- Clinical research informatics
- Information science
- Data governance
Background:
- Data management is crucial for organizational strategy and clinical trial success.
- Technology and computerized systems are now standard in clinical trials.
- The U.S. Food and Drug Administration (FDA) mandates standards for electronic records and signatures.
Purpose of the Study:
- To review common aspects of data management.
- To discuss data management systems in the context of clinical trials.
- To highlight the importance of experienced data management teams.
Main Methods:
- Review of data management principles.
- Analysis of technological integration in clinical trials.
- Examination of regulatory requirements for electronic data.
Main Results:
- Clinical data management is integral to trial success.
- Technological adoption in trials is widespread.
- FDA regulations ensure data integrity and reliability.
- Skilled data management teams are essential for protocol success.
Conclusions:
- Robust data management strategies, supported by technology and expert teams, are vital for successful clinical trials.
- Adherence to regulatory standards ensures the trustworthiness of electronic data.
- Effective data management encompasses collection, organization, and system utilization.
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