edc


	TrialDriver Electronic Data Capture (EDC)


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	TrialDriver EDC

TrialDriver provides a unique and innovative solution to electronic data capture at the investigator sites. Building on the image-based nature of the TrialDriver system as a whole, it implements an interactive forms-based environment which exactly mimics the use of paper CRFs in an on-screen implementation.

E-CRFs are filled in online utilizing exactly the same interactive data validations and edit checks that constrain online data entry operators working with paper-based CRFs. E-CRFs and paper CRFs, being structured in exactly the same manner, can be used seamlessly in the same study, enabling a hybrid solution encompassing both paper and EDC.

A unique property of the TrialDriver EDC system is that EDC data can be rendered as paper CRF images and saved as PDF files, opening a multitude of possibilities for the integration of EDC and paper based data. Because pages can be rendered and printed at any time, they can be stored as subject dossiers for submission or offline scrutiny.

Crucially, Site Monitors can log in to the E-CRFs created by the sites assigned to them and remotely perform Source Document Verification, which is fully integrated into the EDC Client application.



	E-CRF login screen


	Subject Overview screen

Investigators log in to the user-friendly EDC client application, and are presented with a list of the studies in which they are participating.

Choosing one of these studies opens a list of subjects which have been (or still can be) registered with study management. The list provides an overview of subject status and on-screen controls allow the enrollment of new subjects.

Selecting one of the subjects then opens the E-CRF proper (see screenshot below). Interactive form controls display a color-coded status indicating which fields need to be filled-in, and if there are any data validation errors. CRF data is continually saved back to the study server, reducing the risk of losing data.

Finally, when a page is fully validated it is ready to be committed online to data management. Thereafter it is locked unless a reason for change is given and editing re-enabled.

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.

Other material

Querying within the EDC System
Investigator Sign-off

ECRF User Manual (PDF)

ECRF Technical Overview (PDF)

Videos

TIP: These videos are recorded at 1280x720 pixels. If you are viewing them in a browser on a small screen, try pressing F11 - this puts most browsers into "full-screen" mode

1) Introduction to the E-CRF system (9 mins)
An introductory video showing how to log in to the E-CRF system, register ew subjects the basic of data entry and submission.

2) Advanced Data Entry Topics (8:30 mins)
Enrolling subjects for treatment, repeating pages and visits, pages and visits not done, missing data and partial dates

3) Responding to Data Queries (3 mins)
How to view and respond to queries issued by study monitors



	Interactive CRF Form View


	PDF Form View


	Supplementary Documentation


	Local Audit Trail