While the E-CRF presents itself as “online paper”, it has many advantages over real paper. Data entry fields can be hidden in response to certain inputs so that, for instance, if a “Not Done” box is checked then the rest of that panel is hidden.
The E-CRF can be configured for a high level of complexity and repeating pages and visits can be created on a subject-by-subject basis as required (and allowed). Unscheduled visits are normally not shown but can be created on demand. Logging pages can be used and updated incrementally without requiring a specific reason for change.
Very significantly, images of the CRF pages (either blank or populated with subject data) can be created on demand as PDF files. These can be viewed in the built-in PDF viewer and saved, printed or emailed with standard Acrobat controls.
Source Document Verification is fully integrated - monitors receive their own login credentials which authorizes them to monitor one or more sites. The E-CRF opens in a special monitoring mode which does not allow data edits. When a page has been fully verified, it is then locked completely, so that no further changes can be made to it, unless the verification is rescinded.
The EDC client application can also be used to display supplemental study documentation, such as, for instance, the study protocol or FDA forms. The audit trail is always available for scrutiny.
Finally the TrialDriver SharePoint Investigator Portal can be displayed and operated within the EDC client application. Utilizing just a single secure login password for the E-CRF and the Portal, this provides an extremely rich online environment for sites and investigators