“ 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. ”

Why use both Fax and EDC?

When the risks, costs and benefits are compared for Fax and EDC, the final decision as to which is best will vary from one trial to another, and from one evaluator to another depending on individual preferences and beliefs. It may not be easy to make a decision. You may need to plan for both, here's why:

  • Sites Differ

    Everyone has their own preferences, past experiences, familiarity with computer technology, and demands that limit the time available for a research project. Study leaders can maximize their ability to recruit sites, and keep them happy, if they can offer a data collection system that fits the needs of each site. It might be Fax for one and EDC for another.

  • Assessments Differ

    Some patient assessments are more suited to Fax and others to EDC. For example, a patient diary containing visual analog scales (VAS) may be easiest to collect using a paper form. DataFax ICR is able to read these scales when they are faxed to the study server - no ruler or manual data entry required.

  • Source Documents May be Needed

    If copies of source documents must be collected, EDC is not even an option. A system that is able to receive source documents by fax, store them in the study database, and link them to data records containing information extracted from the source documents can meet this requirement.

  • Data Entry Errors Happen

    Let's face it - we all hit the wrong key now and then. Wouldn't it be useful to be able to assess the extent to which this occurs at the clinical sites that are using EDC? In many 'EDC' trials the clinical sites first complete CRFs and then enter data into an EDC system from these paper forms. One way to check data entry accuracy would be to have the sites enter the data and then fax the CRF pages to DataFax where they will be linked to the corresponding data record enabling central data management staff can compare them. Even if used only during an initial training period, or on a random sample of CRFs, this could be a useful quality control step for any EDC trial.

  • Keep Your Options Open

    Despite our best intentions a site may discover that EDC is too disruptive to the work flow in their practice, or the person who regularly performed EDC might leave and be replaced by someone who is all thumbs, or hurricane Omega might make an internet connection unavailable for weeks on end. Having the ability to carry on using a lower level technology (paper forms), for whatever reason, may make the difference between keeping and losing a site. Having a system that is designed to work both ways from the outset will make switching easy, if it is ever required.