Electronic Data Capture (EDC)

The true benefit of using Electronic Data Capture lies in the immediate feedback on incorrect data values, thus resulting in a much steeper learning curve of sites on how to avoid data-entry errors and resulting in a less queries having to be sent from the central Data Management office to the sites.

Running a study in EDC mode, only requires a few additional steps in DataFax. You still need to define a study database, which is the same for both paper-based studies or EDC based studies. And you still need to define Edit Checks, validating your clinical data. Exactly the same Edit Checks can be used for paper-based as for EDC. However, a difference is that in a paper-based study, Queries will be handled by experienced and well-trained Data Managers. While in an EDC study, Queries will be handled by less experienced and probably less extensively trained investigators. As a result, the handling of Queries in EDC will probably require more fine-tuning than in a paper-based study.

And another major difference will be related to security. In a paper-based study, all information is handled by Data Managers, usually they have access to all records of all patients. With EDC, access for each site needs to be limited to only patients of that site. It goes without saying that DataFax has a Study Administration tool available which will allow you to fine-tune security setting. Roles can be specified, which, as an example, will specify that a site can only access its own patients, is able to add new queries, but is not able to approve the answer to a query, etc.

Thorin - DataFax - Data Collection Methods - EDC

And whether you receive data by Fax, e-Mail, or EDC, they all end up in the same data structure. This will allow you to flexibly combine and mix each of the different collection methods into a single study or to select a collection method which best fits a given study type. Like using EDC in a phase II study where speed is more relevant and using Faxing in a phase IV study where cost is more relevant.

Online Demo

An Online Demo is the best way to get a more indepth understanding of DataFax. By using GoToMeeting, we are able to display DataFax on one or more PC's in your office, while audio is provided by phone.

Thus we are able to interact with you and show you a 'life answer' to any of your questions.

To request an online Demo: Thorin contact page