- iDataFax: attaching a PDF file to a data record
21 CFR Part 11 Compliance
Designed for studies subject to regulatory review, iDataFax includes: electronic signatures, password aging, reuse, complexity and lockout rules, fine-grained user permissions, audit trails, and secure 128 bit SSL encryption of all data and document transmissions over the internet.
True Hybrid System
iDataFax supports: electronic data capture (EDC), processing CRFs received by fax or as PDF transmissions over the internet, and data imports from labs and other sources, enabling you to select the best data collection method for each: study, site, investigator, and patient assessment, and to combine different methods in any study.
Electronic Data Capture (EDC)
iDataFax is a full featured EDC tool that’s very easy to learn and use.
- familiar patient binder interface with data entry screens that match study CRFs exactly
- enables users to enter reasons for data values and missing fields, and reply to data queries
- includes: lookup tables, drop-down lists, sliders, range and edit checks, help messages, etc.
Capture Paper CRFs by Fax
As an alternative to EDC sites can fax CRFs to the study server for centralized data entry.
- CRFs received by the study server are read by intelligent character recognition (ICR)
- ICR reads numbers, dates, check boxes, and visual analog scales as soon as a fax arrives
- central data managers correct ICR as needed and then save each CRF page and data record
Capture Scanned CRFs
Instead of faxing, sites can scan CRFs to PDF files and transmit them over the internet.
- PDFs can be transmitted from a user’s PC to the study server using iDataFax or DFsend
- secure transmission with: authentication, encryption and tracking by user, date, time and filename
- CRFs received as PDFs are processed just like a fax, including ICR and central review
Import Patient Documents
Unlike most EDC systems, iDataFax allows users to import paper forms and attach them to data records.
- CRFs, work sheets and other patient documents are scanned to create PDF files
- iDataFax allows users to import PDFs and attach them to the relevant data records
Import Lab and other Data Files
Users who have been granted permission can use iDataFax to import data from ASCII files
- create and save a field mapping template for each lab or other data source
- import both new data records and corrections
- identify problems before import including: missing, invalid and illegal values
Extensive Data Management Features
iDataFax includes features to help you monitor study progress and review, query, correct, and validate the data you collect.
- create study roles for users with different permissions and responsibilities
- customize iDataFax look and feel for specified users and study roles
- manage work flow by defining tasks and assigning them to specific users or roles
- create queries manually or automatically using real time or batch edit checks
- create rules to automatically flag: overdue visits and missing data records
- manage queries using query views, query search, query tasks and query reports
- use standard study reports to monitor: sites, patients, and data workflow.
- search the audit trail for changes made to data, queries and reasons
- create spreadsheet views of selected data fields for review and export to ASCII files
- create and manage SAS exports for statistical analysis
- create bookmarked PDFs containing specified patient data and images
You Have Options
Download and install iDataFax on your PC, Mac or Linux desktop for maximum performance and enhanced functionality, or run it from a web browser by connecting to our DF Navigator application server for maximum convenience.