DataFax Review

DataFax’s primary EDC solutions include detailed user permissions that determine what each team member can see and do. By identifying what a user can create, modify and view, administrators can be more secure knowing that only the necessary information needed for a study report are released.

The EDC module also boasts of an intuitive user interface, with an organized set of patient binders and screens that match paper CRFs. This makes the software easy to learn and use, so that users can get up to speed with the technology and get more work done.

Status icons help sites recognize patients, visits and screens where data entry is not yet complete. These quick status checks allow users to update information fast in order to avoid errors.

DataFax EDC’s data entry help include drop down lists, lookup tables, field level color coding, range checks, and help messages. Users can facilitate real-time edit or custom checks to detect  problems, display warnings, request corrections, create queries, compute derived values, trigger email messages, and more. All these aid in upholding the accuracy of data entries.

Users can easily respond to data queries as iDataFax Query View sites display all outstanding queries and jump to the corresponding data screen. These even have color coding and status icons to help sites identify and respond to each query.

iDataFax users can attach a reason to any data field to explain missing or atypical values. These help lessen queries from data managers so that users can focus on more important matters.

DataFax’s Electronic Paper Capture module delivers an authentic hybrid system for collecting, processing and storing both data and images of paper documents. It has Intelligent Character Recognition (ICR) that can read handwritten numbers, dates, check boxes and visual analog scales (VAS). While accuracy depends on the clarity of handwriting, at least 90% of data fields are said to be read correctly from most study sites. Paper records such as worksheets and source documents can be captured, linked to patient data records, and stored in the study database. Sites can also send completed CRFs to the study server to build an initial data record for split-screen review, correction and entry by data managers. All these are safely transmitted under regulatory requirements for authentication and tracking, with 256 bit SSL encryption.

DataFax’s Data Management module is useful for data reviews, coding tasks, importing lab data, exporting SAS data sets, and more. Queries can be created manually or by edit checks, then automatically resolved when the originating problem is attended to. Users can add reasons and replies, which can be reviewed and approved, to aid in proper team communications. Data can be exported to flat ASCII files, or to SAS data sets, as well as imported from labs and other sources using a simple field mapping dialog. Extensive search capabilities allow auto and manual coding for drugs, adverse events, and other using configurable lookup tables. Study managers can indicate tasks for any user or study role, complete with instructions and workflow steps, to quickly assemble all data records meeting the specified task criteria. Work flow management tools allow monitoring of data records in all levels to ensure that all tasks are accomplished.