It has been more than 20 years since the FDA established that electronic documents and signatures were trustworthy and acceptable for use in clinical research (so long as they meet 21 CFR Part 11 requirements). In that time, many research organizations have taken the opportunity to free themselves of the struggle to manage mountains of paper and chase down doctors for signatures. But many have yet to make the transition.
For many research organizations, the incoming stream of regulatory documents that require printing, routing, signing, and filing is never-ending. Apart from the long turn-around times, collecting signatures on DOA logs, 1572s, protocols, IRB approvals, financial disclosures and training documents carries the risk of lost documents, incorrect date formats, or deadlines missed.
Jeremy Rigby, President of Advanced Clinical Research (ACR), shared his story during a recent webinar about the complex manhunt he had to set in motion in order to get the signature of a physician who was on a rural bicycle vacation. That experience helped to push ACR into their decision to transition to an electronic regulatory (eRegulatory) solution. And now, having adopted electronic signatures, such manhunts are no longer necessary.
When integrated with purpose-built eRegulatory solution, research organizations reap several benefits from eSignatures, including:
- Cost reduction by eliminating document handling costs and reducing time needed to manually prepare, ship and archive paper documents
- Increase staff productivity by allowing PI’s and staff to sign from any mobile device
- Improved visibility over outstanding activities w/out maintaining separate logs
- Strengthened security and compliance with embedded audit trails, less errors, and reduced likelihood of losing a document
- The ability to demonstrate green business practices by maintaining digital-only documents and forms
With the FDA’s support, the considerable benefits of electronic documents and signatures, not to mention the general ubiquity and acceptance of eRegulatory technology - sites must embrace electronic processes in order to compete. Thankfully, since many have already made the transition, others no longer need to go at it alone.
A new Complion whitepaper, “Signed, Sealed, Delivered: Streamlining Regulatory Processes with eSignatures” presents the details of the transformation that brought two leading clinical research sites into the 21st century. The article explores the problems inherent in today's regulatory processes, applicable FDA regulations, and a wealth of insight and best practices to help ensure the success of your organization’s transformation.
If you are trying to navigate when and how to adopt eSignatures or are curious about organizational impact of that transition, download your copy of Signed, Sealed, Delivered: Streamlining Regulatory Processes with eSignatures today.