Techopedia Explains Electronic Data Capture (EDC)
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
- Query management
- Data audit trail
- Inspection of data changes
- Data exporting
- Multi-level user access
- Report generation
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.