EDC workflow is superior to traditional paper-based data management systems. In the paper-based model, the time from LPLV to locked database is on average 6-7 weeks. This is due to the fact that DM personnel have to wait for CRA's to monitor sites and receive the last large bolus of data. That data needs to be entered, cleaned and DCFs need to be generated and sent to the sites for resolution.
EDC studies can be locked within 1 week from LPLV. This is due to data is entered and cleaned in near real time. DM is truely waiting on the last patient's last vist not the last bolus of data that needed to be monitored.
It does require excellent communication between site personnel, clinical monitoring staff and data management to achieve these timelines. DM should be notified in advance of close out visits and be prepared to resolve any issues while the CRA is present at the close out visit