Electronic data capture

Electronic data capture (EDC) is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials.

Overview

EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices. EDC solutions are widely adopted by pharmaceutical companies and contract research organizations (CRO).

History

The use of EDC systems has been increasing rapidly in the clinical trials industry. The first EDC systems were introduced in the late 1980s and early 1990s. The early systems were custom-built by the pharmaceutical companies who wanted to automate the data capture process.

Types of EDC

There are several types of EDC systems including:

• Remote data capture (RDC)
• Clinical data management system (CDMS)
• Clinical trial management system (CTMS)

Benefits

EDC systems offer a range of benefits such as:

• Improved data quality
• Faster data collection
• Cost savings
• Compliance with regulatory requirements

Challenges

Despite the benefits, there are also challenges in implementing EDC systems including:

• High initial cost
• Need for training
• Data security concerns

See also

• Clinical data management
• Clinical trial
• Pharmaceutical industry
• Contract research organization

References

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