It has been more than 20 years since the FDA established electronic documents and signatures are acceptable for use in clinical research (so long as they meet 21 CFR Part 11 requirements).
In that time, many research organizations have freed themselves of the struggle to manage mountains of paper and chase down doctors for signatures. But many remain to make the transition.
For many research organizations, the incoming stream of regulatory documents that require printing, routing, signing, and filing is never-ending. Aside from the long turnaround times, collection of signatures on DOA logs, 1572s, protocols, IRB approvals, financial disclosures and training documents, there is the risk of lost documents, incorrect date formats, and missed deadlines.
Jeremy Rigby, President and Executive Director of Advanced Clinical Research (ACR), shared a story about the complex manhunt he had to set in motion at one time in order to get the signature of a physician who was on a rural bicycle vacation. That experience helped to push ACR into the decision to transition to an electronic regulatory (eRegulatory) solution. And now, having adopted electronic signatures, such manhunts are no longer necessary.
When integrated with a 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;
- Increased 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; and
- 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 as well as the general ubiquity and acceptance of eRegulatory technology — sites must embrace electronic processes to compete. Thankfully, those that have not yet made the transition, need to go it alone.
Complion’s whitepaper, “Signed, Sealed, Delivered: Streamlining Regulatory Processes with eSignatures”, reviews the transformation to eRegulatory that two leading clinical research sites made. 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 the organizational impact of that transition, download your own copy of “Signed, Sealed, Delivered: Streamlining Regulatory Processes with eSignatures”.
Complion’s team has developed expertise in 21 CFR Part 11 regulations. Our platform is Part 11 compliant, and we are happy to partner with you to do everything required for compliance, including validation, training and process development. See how we can help.
