“ DataFax levels the playing field for our small company in competing with the 'big companies'. Long gone are the days of the slow and labor-intensive process of physically retrieving hard copy case report forms from investigative sites, and thumbing through them for data entry and clean-up. ”

What is DataFax EDC?

Instead of faxing paper CRFs the clinical sites can use iDataFax to enter patient data, reasons for unusual values, and replies to queries from the study coordinating center, and send it over a secure internet connection to a central DataFax server. This is often referred to as EDC (electronic data capture).

How does it work?

  • A user downloads iDataFax and installs it on their PC or MAC with a few mouse clicks, using a standard MS Windows or Apple MacIntosh installer. This operation is performed only once and takes 5-10 minutes.
  • To enter data a user starts iDataFax, selects the DataFax server at the study coordinating center, and enters their login name and password.
  • iDataFax lists all of the studies running on the server for which the user is authorized to enter or review data.
  • After selecting a study users are able to open patient binders for which they have permission. These electronic patient binders are organized like paper binders with data forms nested within a series of patient assessments or visits. The data screens visible on opening a binder are exact replicas of the paper CRFs, and just as easy to complete.
  • When a binder is selected it is locked for exclusive use by the user. Other authorized users can open the same binder in view only mode, until it is released.
  • On opening a patient binder the user can review previously entered data, make corrections, enter reasons to explain invalid values, reply to queries from the study coordinating center, and enter new data.
  • On tabbing into each field any relevant queries, reasons or help messages appear in designated parts of the screen.
  • Data fields are color coded to show whether they are required or optional and currently valid or invalid, and edit checks with access to all data in the patient binder run locally in iDataFax to immediately notify the user of any problems.
  • When finished with a page the user sends it to the coordinating center by cliking one of 3 save buttons: 'Final', 'Incomplete' or 'Pending'. DataFax does not prevent users from saving incomplete or invalid data values. This may be the best that can be done at the time. Users can easily locate invalid and incomplete data fields to correct or complete them at another time.
  • iDataFax also includes many views and functions useful to study managers and statisticians at the coordinating center including: task management, standard reports, query management, and SAS and ASCII exports, to name a few. All data permissions, functions and views are under permission control defined in study roles to which users are assigned.