Definition - What does Electronic Data Capture (EDC) mean?
Electronic data capture (EDC) is the computerized collection and management of clinical trial data from patients and subjects. An EDC system uses technology to streamline the collection and transmission of clinical trial data from the patient to the research laboratory. The process reduces data errors to provide researchers with improved data quality. In addition, it speeds up the entire clinical trial process, thus reducing research costs.
EDC solutions are widely used for clinical trials and research purposes by clinical research organizations, biotechnology and pharmaceutical industries, and also for safety surveillance activities.
Clinical trials data at the source may first be recorded on paper and then entered into the electronic case report form, or be fed directly into the electronic case report form (eCRF). Another entry procedure is the interactive voice response system (IVR), wherein the patient reports information through a telephone or point of contact data collection system. This is known as electronic patient reported outcomes (ePRO), and data is captured using devices such as tablets or digital pens.
EDC systems are either commercial, open source or in-house developed. The system may be standalone, server based, or a multi-site, Web-based system. Most of the systems have common features that enable the streamlining of data collection, management and easy data exchange between the various devices and systems. A typical EDC system includes a graphical user interface for data entry, a data validation component and a reporting tool.
Some common features of EDC systems include:
Standard electronic case report forms (eCRF)
Data entry with real-time data validation
Data audit trail
Inspection of data changes
Multi-level user access
The advantages of EDC systems include quicker data access, data security, accurate and organized data, efficiency and cost-effective compliance with regulatory requirements. Web-based systems with online data collection forms allow real-time, multi-user, multi-site data collection and editing.