The EMA has called for an Inspectors Working Group on EDC systems and risk based monitoring in clinical trials on November 30, 2015 at their headquarters in London, UK. As one of global stakeholders, ACRES has been asked to send a representative to the meeting to partake in the discussions. The day is dedicated to discussing electronic systems supporting clinical trials, their advantages and associated risks. The second half of the day is dedicated to risk based monitoring approaches presented from industry and service provider perspective.