Clinical DataFax Systems Inc - whatisdatafax

By: Datafax  09-12-2011

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.

  • 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.
  • 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.


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Clinical DataFax Systems Inc - whatisidatafax

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. When finished with a page the user sends it to the coordinating center by cliking one of 3 save buttons: 'Final', 'Incomplete' or 'Pending'.


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Clinical DataFax Systems Inc - datafaxfeatures

When the review is complete the data record is saved in the study database with status 'Final' if the record is complete and status 'Incomplete' or 'Pending' if the record contains invalid values or outstanding data queries. Intelligent character recognition software scans each CRF page and completes as many of the data fields as possible. Queries created by study management staff or edit checks.


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Clinical DataFax Systems Inc - whyfax

A well designed paper CRF is a creation of remarkable beauty and simplicity; light weight, no power or internet requirements, easy to navigate, and familiar to all.