Pros and Cons of e-Signatures in Clinical Research

As the clinical research industry moves into an increasingly paperless, electronic world, all stakeholders involved in clinical trial processes are faced with new workflows that include numerous benefits. However, in some cases, new challenges must be overcome. The move to electronic systems has been greatly accelerated due to Covid-19 as the need for contactless processes quickly increased, but the reality is that our industry was already moving into these advanced systems due to the numerous benefits that they offer. The uptake prior to Covid-19 was much slower, perhaps as a result of change itself, but there are inherent challenges that the industry will collectively have to overcome as we move toward complete adoption across our industry. One example of the above is with the adoption of electronic signatures on clinical research-related documents, to include highly regulated documents such as FDA 1572s, subject informed consent forms (ICFs), e-Delegation logs and more. It is easy to realize the powerful advancements that e-signatures offer to clinical research. First and foremost, it offers complete accountability. Utilizing a pen and paper, it is difficult to concretely prove that a signature is both authentic and timely as signatures can easily be forged and/or entered late and back-dated. With e-signatures, users are digitally authenticated utilizing complex login credentials, time, date, IP address and other electronic metadata. Further, this authentication information is recorded in audit trails allowing for complete accountability. For sponsors, CROs and the FDA, this level of accountability and proof of oversight should be highly sought after to ensure data integrity and patient safety. For sites, this level of scrutiny may be a bit scary, but good sites need the same level of transparency to ensure quality, accuracy, oversight and accountability of their staff and investigators. Other advantages of e-signatures include being able to sign from anywhere as long as a computer or smartphone and internet connection are available. The days of chasing investigators around for signatures are over for sites that use e-signature capable systems. In addition, investigators and staff have the ability to receive push notifications or email alerts when e-signatures are needed so they can work e-signing into their day when it makes sense. As with any new technology or process, change is required, and change can be challenging in any circumstance. But in the case of e-signatures, processes are mostly improved and streamlined which makes the change quite simple. One of the biggest barriers to e-signature adoption is simply concern. The biggest concern is that e-signatures may not be accepted by other parties or authorities such as the FDA. In fact, the FDA has written very clear guidance to allow for e-signature adoption; therefore, as long as compliant systems are used, there should be no barriers to the implementation of e-signatures and taking advantage of these vastly improved e-signature processes. Further, these more advanced systems permit sign-on-the-line technology that allows for section-specific signing by multiple parties, user-selection of checkboxes and comment box areas to add additional statements of testament. In short, there are far more advantages to e-signature utilization in clinical research. The only real disadvantages are the lack of adoption and acceptance by certain stakeholders due to misconceptions around regulatory compliance. Thankfully, at this point in the user-adoption curve, we are seeing widespread acceptance and greatly improved document signing processes, further paving the way for a streamlined, paperless, decentralized clinical research world! Special thanks to our friends at SCRS for publishing this article! Read more of the SCRS InFocus Newsletter where you can learn about insights and solutions to help sites and other stakeholders to ensure sustainability.