Sign on the Line Technology Addresses eSignature Limitations

To address concerns of clinical research site auditors and regulators, RealTime Software Solutions now offers Sign on the Line technology integrated across all CTMS and eDOCS systems at no additional cost to customers. The new software feature utilizes similar technology to DocuSign and HelloSign to place actual signature impressions throughout a document.

This highly requested feature now allows clinical trial research sites, Contract Research Organizations and trial sponsors to collect FDA Part 11 compliant electronic signatures exactly where required on a document.

Sign on the Line technology allows users to sign records such as FDA Form 1572s, Financial Disclosure Forms and binding study agreements. Current eSignatures offered within other clinical research document management systems only allow for one general eSignature on the back page of a record to indicate a signatory’s approval or acknowledgement of an entire document. Additionally, current technologies do not allow for acknowledgements of specific sections, the ability to checkmark certain areas as true/false or yes/no, or include additional elements such as comment fields and date insertions.

The limitations of current eSignature solutions are a concern with auditors and regulators, says Rick Greenfield, CEO and lead inventor, RealTime Software Solutions LLC.

“Capturing an investigator’s signature on the signature line of an FDA-regulated document is important, and regulators have voiced concerns with how legacy systems handle eSignatures,” he says. “RealTime is committed to improving these advanced electronic systems for all stakeholders to ensure better, more efficient and more compliant processes.”