Can I use Fax and EDC in the same study?
Yes. DataFax is a true Fax and EDC hybrid system.
You can choose the method best suited to an individual investigator,
clinical site, patient assessment or data form.
And, if you change your mind, or unanticipated circumstances arise,
you can switch from one method to the other at any time.
How do Fax and EDC work together?
- Whether you plan to use Fax, EDC, or both, the study is setup
in exactly the same way.
- Study setup begins with the design of study case report forms (CRFs),
suitable for printing on standard US letter or A4 pages, and for
deploying as an sequential set of assessments in a patient binder.
- These CRF pages are used in the DataFax Setup tool to define the
data fields and create the study database schema.
- These CRF pages also become the backgrounds for the data entry screens
used in iDataFax for both the Fax and EDC data entry methods.
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Since the paper forms and the data screens are identical it is very easy
for the clinical sites to switch from paper to iDataFax, or vice versa.
- Whether the central DataFax study server
receives data by fax or by EDC it stores it in the same study database.
The only difference is that when faxed an image file containing the CRF page is
stored along with the data record.
- Data records created by EDC in iDataFax can also have associated image files.
It is possible to use iDataFax to enter data, and then to fax the CRF
or a source document for linkage with the data record.
iDataFax can display a data record and its associated images together,
either by toggling between the data and image views or by splitting the screen.
- Because data collected by Fax and EDC are stored in the same database tables
both data collection methods share common features including: user permissions to
view, create and modify data records, queries and reasons; the application of
edit checks used to ensure data completeness and consistency; the application
of patient scheduling and CRF requirement rules; and the creation of
study progress reports and SAS data sets,
to mention just a few.
- The availability of both Fax and EDC in any DataFax study removes the risk of
making the wrong choice between these 2 methods of data collection,
as a switch to the other method for all or some of the data records is always possible.