EDC Discussion Forum

Dawn and Dan here to blog again!

dcrawford — Mon, 17 Aug 2009 10:24:09 -0400

Dawn and Dan here to blog again! We just finished a great seminar with SCDM focusing on trends for EDC today and in the future. One of the most interesting parts of the webinar (both to talk and write about) was the use of reports to monitor clinical data.
Using EDC not only lets you see the data a lot quicker (and cleaner) than paper studies ever did, but it also enables you to use real time tools to understand and “data mine” in near real time.

EDC Discussion Forum

Study Close out

dcrawford — Thu, 13 Mar 2008 15:19:13 -0400

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 Discussion Forum

Query Process and Benefits of EDC

dkaminski — Thu, 06 Mar 2008 16:15:45 -0500

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!

EDC Discussion Forum

DataBase Lock Procedures

dkaminski — Thu, 06 Mar 2008 16:05:12 -0500

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:

EDC Discussion Forum

Study Setup Time Efficiencies

dkaminski — Tue, 26 Feb 2008 22:44:28 -0500

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.