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Clinical Trial Data Management Software: A Review of the Technical Features
Aynaz Nourani1, Haleh Ayatollahi2, Masoud Solaymani Dodaran3
1Department of Health Information Management, School of Health Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran.
Clinical trial data management systems are crucial but often lack full functionality. This review highlights the need for more robust, flexible, and high-quality systems to improve clinical trial data management.
Area of Science:
- Clinical Research
- Health Informatics
- Information Technology
Background:
- Data management is a complex, vital process in clinical trials.
- Information technology is essential for efficient clinical trial data management.
- Clinical data management systems (CDMS) are software solutions for handling trial data.
Purpose of the Study:
- To review the technical features of clinical data management systems used in clinical trials.
Main Methods:
- A literature search was conducted across major scientific databases (Web of Science, Scopus, PubMed, etc.).
- Research papers published between 2007 and 2017 focusing on CDMS were included (n=19).
Main Results:
- Most CDMS reviewed were web-based and developed rapidly for specific trials.
- SQL Server and MySQL were common database technologies.
- Many systems exhibited limitations in supporting comprehensive data management and lacked flexibility.
Conclusions:
- Existing CDMS often inadequately support data management and workflow processes in clinical trials.
- There is a need for improved design focusing on completeness, usability, and quality.
- Further research is recommended to identify features of successful CDMS.
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