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While the use of electronic data capture (EDC) in clinical trials is not a regulatory requirement, it is quickly becoming a de facto standard. Because it adds flexibility, efficiency, and convenience to the data capture process, EDC can be a powerful addition to your clinical trial implementation toolbox. When considering an EDC system, there are four specific factors you should take into account to ensure a successful implementation.
- The data collection forms and database must be finalized before patient screening begins. This may lengthen the pre-study phase, but the benefits will outweigh any inconveniences.
- Your study sites must be compatible with the EDC system. They must be equipped with computers, have a high-speed Internet connection, and be staffed by people who are comfortable using these tools.
- Your service provider should offer system training, and the system should be relatively easy for the study sites to use.
- Make sure your study data is stored, backed up, and protected. This is vitally important. Your CRO or EDC vendor must have formal procedures in place to ensure that software development and change management processes comply with 21 CFR Part 11 and that there is sufficient redundancy in the system to protect and maintain the integrity of the data.
The benefits of using EDC in your clinical trial can be significant. They include:
- Real-time data access for sponsors, sites, and CROs
- Increased project-management efficiencies
- Faster database lock than with a paper-based system
- Flexible data capture form design
- Automated edit checks, reducing errors associated with data input
- Real-time query resolution, reducing data cleaning time at the end of the study
- Viewable audit trail for data changes
- Elimination of cost to print and ship paper-based case report forms
Promedica International is an ISO-certified CRO that provides project management, site recruitment, site monitoring, data management, biostatistics, and medical writing to the medical device, biotech and pharmaceutical companies. To learn more, visit the company’s listing in the online Consultants Directory or go to the firm’s Web site at www.promedica-intl.com.
