By Keith Howells
Electronic Data Capture (EDC) refers to the collection of medical data for patients enrolled in clinical trials. The most common mechanism is for staff at the investigative site to enter the data into a web-based interface, and for staff at the sponsor company to monitor the data using the same interface but with different security permissions. The monitoring includes handling queries, such as for data values outside expected ranges, and checking that the data matches the source data in the patient’s medical record. The use of EDC has largely replaced the prior mechanism of collecting data on paper forms and subsequently typing that data into a back-end Clinical Database Management System.
The primary benefits of EDC are earlier visibility into the data, faster resolution of queries, and a shorter time lag between the end of the study and the availability of the data for analysis. This in turn helps the sponsor company make quicker decisions on the next study for the medical product, or to curtail the research in favor of more promising products; only one in four pharmaceutical products entering clinical trials will eventually reach the market, so taking prompt action on unsuccessful products can save a lot of resources.