The creation of Theradox® as a Fax/Image/Data-Capture System (FIDS) has revolutionized the speed of data capture and the maintenance of data integrity by facsimile transfer of case report forms directly from the site to the CRO. The ubiquitous nature of facsimile machines reduces the need for expensive equipment at the study site, thus reducing equipment costs, as well as training costs. Real time data transfer has enhanced the timeliness of database updates with newly captured patient data. As a result, the Theradox®/FIDS system is currently being used in a number of large scale, multi-center clinical trials.

Case report forms have been designed for use with the Theradox® data capture system. Orienting footprints have been incorporated into each case report form, thus enabling the image to be correctly aligned for reproduction by the receiving fax machine. Also included within each form are identifying marks that automatically produce a list of received forms to be faxed back to the site for confirmation of the receipt of transferred case report forms, in addition to directing the transferred CRF images and data to the appropriate patient file. Boxed areas allow printed numeric and literal character entry, while optical mark recognition areas allow for the entry of categorical data. Editing to ensure accuracy is accomplished through the comparison of the imaged form with the computer completed shell by a data entry operator. Fax numbers are assigned per protocol to direct imaged CRFs into the correct folder of the imaging system.

There are significant advantages to using the Theradox® system. Direct data transfer eliminates the need for physical handling, movement and storage of medical records. This allows for the maintenance of the most current database, as it removes the complication and risks associated with mail transfer. Theradox® also allows monitoring staff to review all available medical records prior to a routine monitoring visit. As a result, Theradox® reduces the need for costly equipment and training associated with more complicated data transmission systems.