Insights Blog

Electronic Signatures in Clinical Research: Lifting the Paper Curse

Posted on Oct 31, 2017 10:23:58 AM

Scenes of someone being relentlessly pursued, perhaps by zombies, vampires, flying sharks, or some combination of any or all of the above, are common on TV during Halloween season. And that’s ok. But somewhat similar scenes are also playing out in the halls of research facilities as research nurses or regulatory coordinators attempt to chase down busy Primary Investigators (PIs) whose signatures are needed on essential documents. Staff members set up ambushes, pen and documents in hand, waiting for unsuspecting PIs. Or they set out the documents where they hope the PIs will see and sign them, which only increases the chances that the documents will disappear.

Often referred to as “PI Stalking” or “Signature Chasing,” this practice is to organizational efficiency what a bag of Halloween candy is to good nutrition. The people doing the stalking and chasing have better things to do with their time, and your organization has better things to do than continuously feeding The Thing That Ate The Budget.

The nightmarish prospect of wasted time, misplaced files, incorrect signatures, and wildly annoyed PIs is the result of the Paper Curse, the all too common cycle that begins when a document that is already in electronic form gets printed out. The pages in that document are then arranged in the proper order, instructions and memos on what to look at and where to sign are added, and the signature page is modified to reflect site SOP's (Standard Operating Procedures). The now even larger document must then be physically delivered -- by staff, by mail, or by some other means -- to the person whose signature is required. Then it’s a matter of waiting for the signature. Once the necessary “wet” signature is added, the document must then be returned. After a review for accuracy, the document is placed in a paper regulatory binder and sent to physical storage, while a digital copy of the document is created and uploaded to the shared electronic drive.

Hybrid Paper & Electronic Process for Obtaining Wet Signatures

Hybrid Signature Aproach.jpg

What’s wrong with that picture? Treat yourself to a piece of Halloween candy if the question that comes to mind is, “Why are we printing documents and then converting them back to electronic format?”

According to a 2014 CenterWatch/Complion study, the typical research site staff spends on average 2 hours per week, per study, obtaining wet-ink signatures. For a site with 20 open trials, that translates to 2,080 hours a year. That’s the equivalent of a full time employee! Pretty scary, right? But with Complion you can end that nightmare by allowing staff to route documents electronically for signature.

At the recent 2017 Global Site Solutions Summit, Dr. Bryce Palchick, MD of Preferred Primary Care Research (PPCP) in Pittsburgh, PA, presented the workshop "Effective eRegulatory and Document Management - What Successful Sites are Doing." During that workshop Dr. Palchik described how he was able to use his mobile phone to sign a document while on an airplane on his way to the conference. The process took only a few minutes, eliminating the need for his staff to wait three days for his return to the office. The system that made that process possible? Complion.

Using Complion, the signature date and format is always accurate because it is controlled by the system. Signed documents are immediately stored in the correct location in the electronic binder. But most importantly, control over documents is maintained because no paper documents are printed, moved, or duplicated. This eliminates mistakes and the risk of lost files, reduces redundancy, improves visibility, and allows busy staff to stop stalking PIs and focus on what’s important.

You can end the stalking and bring the nightmare scenario to an end. Download the article below to learn more about transitioning away from paper and wet signatures or contact us to explore how Complion can save time, improve compliance, and lift the Paper Curse.

Steps to Paperless Clinical Trials

Topics: Paperless Clinical Trials, Paperless Research Sites, Electronic Signatures


Abbie Hosta

Written by Abbie Hosta

Abbie manages the educational and marketing efforts at Complion, a company dedicated to transforming the way clinical trial documentation is maintained. She is passionate about technology, education, and finding new ways to solve old problems. Her goal is to deliver knowledge and value in every interaction. Abbie has a B.A. from Baldwin-Wallace University where she studied Marketing and Human Resources.

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Complion provides clinical research sites and their sponsors with a software platform to enable secure, compliant and efficient management of documents and administrative tasks. We would love to hear from you with any questions about our Insights blog or to learn more about our software platform.

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