“ 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 Fax Data Collection?

Do not mistake fax data collection for a manual process. The clinical sites typically complete paper CRFs even when required to subsequently enter the data into an EDC system. Instead they can fax the CRFs to a DataFax server at the study coordinating center where the fax is received and read by intelligent character recognition software which performs data entry for them.

How does it work?

  • Paper case report forms (CRFs) are completed and faxed from the clinical sites participating in a trial, using standard office fax machines. No computer equipment is required at the clinical sites.
  • When the CRFs are received by a computer running DataFax at the study coordinating center they are automatically indexed and sent to the appropriate study database.
  • Before being stored in the study database DataFax ICR (intelligent character recognition) scans each CRF page and reads the data fields (including: numbers, dates, check boxes, and visual analog scales) to create an initial data record ready for human review.
  • Staff at the study coordinating center review the CRFs and data records using iDataFax split-screen Fax view and: correct any ICR errors, enter any text fields, and create queries to request missing data, corrections for invalid values and other information, as needed.
  • DataFax creates Quality Control Reports containing automatic queries for overdue visits and missing CRF pages plus all outstanding queries created by data management staff and edit checks, and sends them by fax or email to the clinical sites. The sites then correct the original paper CRFs and refaxed them to the DataFax server.
  • All CRF pages (including all versions of corrected forms) are stored along with the data records and queries in an integrated CRF image and data management system.
  • All modifications made to data records and queries are tracked by user, date and time; and audit trail reports can be created for specified users, patients, visits, pages and data fields.
  • A work flow management system tracks all CRF reviews and related tasks at the study coordinating center.