What is an EDC system or Electronic Data Capture System?

An EDC system is a software for storing patient data that are collected during clinical trials. Usually the data is first recorded on paper, and then transcribed into the system and stored in an electronic case report form (eCRF). Today almost all clinical trials are using EDC software to replace paper records with electronic records. EDC systems are being adopted by sponsors, contract research organizations (CROs), and sites to carry out both simple and complex trials in all phases of research. Though there are a lot of EDC vendors, a few organizations build their own in-house system. Most EDC systems offer diverse features, but generally EDC software is designed to rationalize data collection.

The advantages of EDC systems over paper records are:

1     Data security
2.   Easy access to the data
3.   Organization
4.    Accuracy
5.    Compliance
6.    Cheaper

How to choose investigators who can be compliant with FDA inspectional requirements for electronic data capture and direct data entry? How to identify study data elements that require hard copy source documentation? How to design your e CRF to address the origination, authorization, and signature inspectional requirements To get answers for all these questions attend the webinar FDA Electronic Data Capture Guidance - What is the impact on Investigator Site Inspectional Source Record Requirements?