Electronic Data Capture

In recent years, switching to electronic data capture (EDC) has become a more compelling choice for clinical trials to pharmaceutical manufacturers and CROs. Because of the increase in data volume, rising costs, and new drug innovations that target smaller segments of the population, companies must cut their development overhead. Switching from paper-based to electronic data capture can lead to cost savings, higher quality data, and a higher degree of security.

Entrypoint Plus clinical trials software is a proven electronic data capture system used by leading CROs and pharmaceuticals. The software has been validated according to FDA guidelines.

A Proactive Approach to Errors

Many clinical trial data entry software packages deal with error correction. Entrypoint Plus takes a proactive approach by dealing with error prevention, or "intelligent data capture." Intelligent data capture is an integral part of the application design: the application functions so that data entered in one field or form determines what other fields and forms are presented. For example, checking the box next to an adverse reaction displays a form for entering adverse reaction details.

Elements of the trial protocol can be embedded in electronic case report forms. When the protocol is implemented in the CRFs themselves, users don't have to search through manuals to find out how to respond to a question. Instead, the electronic data forms guide them through data entry, determining what, where and how to enter the correct information.

Embedding the trial protocol in electronic case report forms eliminates a large number of discrepancies while the data is keyed. As an example, one company generated 6,000 paper queries at approximately $100 apiece, amounting to over $600,000. Reasons for the queries ranged from not knowing what form to fill out, how to fill it out, what data to enter or box to check, and skipping fields that required input. Switching to Entrypoint Plus electronic case report forms prevented discrepancies during the data entry phase, substantially reducing the number of queries.

Electronic Signatures

Electronic signatures use a special access level, defined via the Entrypoint Plus Administrator module and assigned only to users with authority to sign off on the data. When designing an application, the developer creates one signature field with the signature access level defined in the Administrator, and sets up all other fields in the application to verify whether the signature field has been filled in.

After reviewing records, users with signature access enter their password (electronic signature) in this field. Once a password is entered, the record is considered "frozen." Batches can be closed only if they are frozen. If anyone tries to change data after the record is signed, that user is warned that the batch has been approved and that any change will invalidate the review. If the user makes the change anyway, the signature field is cleared and the batch requires another review. The user can generate an Audit Trail Facility report to view all changes made since the initial freeze.