What is an Electronic Data Capture (EDC) System?

Many clinical data be collected and recorded in clinical trials, such as personal health record (PHR), informed consent form (ICF), clinical trial visit record or lab data etc. In the past the clinical data recorded on paper which is traditional CRFs. With traditional CRFs, it can’t assure data reliability (unintentionally modification) and security (loss paper) cause the processing of data collection and management will become slower. In recent years, the digital questionnaire has been designed for fill in the clinical data that is electronic case report form (eCRF). Software vendors also develop an electronic data capture (EDC) system which is a web-based software application used to collect and manage clinical trial data. The user can design eCRF and auto audit, logic calculation, audit trail, export the chart for statistic software analyzation and de-identification of the subject personal information.
All in all, using EDC system in clinical trial has many advantages, such as:
1. Improve efficiency and accuracy of data collection;
2. Every page, items can merge, collect and analyze different type data;
3. Provide interoperability features to support multi-center trials.
4. Through collection of systemic data, it is beneficial for the long-term follow up of multiple center clinical trial.
5. Identify the staff access qualification to ensure data security and traceability.
Numerous EDC systems has be developed by software vendors on the market. While vary interface from system to system, there is some functionality that you’ll find in just about every EDC solution, such as eCRF designer, query management, data export etc. Using EDC is becoming a tendency during clinical trial, which can improve efficiency of data management, ensure data quality and meet regulatory compliance.
TALENT has many EDC system certifications and rich experience in the design eCRF.
TALENT can provide the service such as design EDC, data management and improve the data quality. Please contact us and we will get in touch.