Query Process and Benefits of EDC
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!
When the forms are submitted, edit checks which have already been programmed into the system at setup run against the data. Then immediately, the site/study coordinator knows what errors they have made/clarifications they need to make to the forms and resubmit.
Queries can also be issued once DM has done a clinical review of the forms. But at this point, those queries will be substantially less than in a paper world due to the fact that the initial set of edit checks have already been run!
Talk about streamlining the process!
