Clinical DataFax Systems Inc - whatisdatafax
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.