Typical study startup time is 8-12 weeks for an EDC study. Even though the startup time is more lengthy than traditional paper based systems, the time at closeout is almost non-existant. This is due to the workflow process used for EDC systems.
Forms are entered at the site, and when submitted, queries automatically fire.
This replaces the traditional process of CRAs going to the sites, seperating paper, mailing in etc....

Octagon has streamlined this process in order to gain even more efficiency--we have cut the typical setup time in half.

One of the main benefits of using an EDC system is the almost immediate feedback on entered data as soon as the form has been submitted.
Compared with the typical paper process of completing the CRF, seperating the copies, mailing into the DM group, review and query, Fedex of DCFs back to the site, answering queries at the site and mailing/faxing back responses (could be 2+ weeks), the query process for an EDC system contains immediate gratification!

Ahh...the old stare and compare process before locking a database. In the EDC world, it is different. Instead of printing CRFs and comparing them to listings (a painful and time consuming process), an EDC close and lock procedure can be completed in as little as 2 days. Because there are no paper CRFs to complete, the process is streamlined.

Once all queries are resolved as a result of online edit checks and Data Management has completed their clinical review of forms, a final set of listings/reports should be run. At this stage, you should be checking on some key items: