Scientists, healthcare leaders and technology leaders have long discussed the potential of an electronic consent process. When done well, its benefits are many, including:
- additional visibility and control for sponsors and clinicians;
- near real-time tracking and reporting consent status by patient, site or region;
- simply and safely managing re-consent; and
- creating a full digital record of consent to demonstrate regulatory compliance.
It is low risk digitization - moving a relatively straightforward paper process to an electronic one. But transitioning to eConsent is only low risk when that eConsent solution is intuitive and easy to use, seamlessly integrated within another clinical trial software, and flexible enough to manage variation and change inherent in today’s clinical trials.
Variation when it comes to consent is particularly salient in country-by-country regulatory differences around how consent is managed and collected. It is also a powerful example of how a simple, intuitive and integrated eConsent and IRT tool can enable sponsors to easily manage through regulatory complexity.
Geographic differences in regulations limit eConsent uptake
Nearly everyone working in clinical trials has a complicated relationship with regulations. We value that regulations aim to ensure patient safety and that experts working directly in clinical trials have input into the development of guidance. But, it can be a challenge to adapt to new regulations, especially when different regulators adopt new approaches at different paces. This leaves our industry in an interesting position: we share a widespread hesitance to act in the absence of explicit guidance. It is hard for us to take action in ambiguity.
Looking across our clinical trials at Suvoda, we’ve seen that when it comes to consent, many sponsors are especially hesitant to adopt an electronic approach in Europe because of the lack of clear guidance around eConsent and the variations in consent regulations across countries. Most European countries allow eConsent - that is, sharing information about the trial electronically. But, several countries have no specific guidance around it, and few allow eSignatures1. Considering eConsent in Europe, or in a global, multi-centered study with sites in Europe, becomes a difficult prospect.
Suvoda eConsent + IRT accommodates differences in consent methods
Suvoda designed our unified eConsent + IRT solution to respond to this, and other types of, variability in consent regulations and requirements. Like our IRT system, the eConsent solution offers the same rigorous flexibility, so sponsors have control over how the system is deployed. In the European case, sponsors have the option of running a fully electronic consent + signature program, a fully paper-based consent + signature program, or a hybrid, depending on the country and site needs. And whatever options sponsors choose, they have the same visibility to and control over the consent process. So even if sponsors use fully paper-based consent or a hybrid of paper and electronic, clinicians can still track consent for real-time visibility and remote monitoring.
This works because our eConsent solution acts much like a consent management system. It can accommodate all consent methods, whether electronic signature, wet ink upload or print + sign. It can accommodate multiple ways of providing information, whether through a PDF uploaded to a patient’s or clinician’s device, or through a micro-website that a patient interacts with. Suvoda’s eConsent can manage consent from many different users: subjects, caregivers, and legally authorized representatives, as well as investigators. And, our eConsent solution can manage the re-consent process in trials with one or more amendments, mitigating regulatory risk and making re-consent simpler for sites.
Seamless eConsent + IRT integration makes it easy to use, even when the study is complex
Change is hard. And with all the variability, protocol amendments and adapting regulations in our industry, it can feel like the only constant. With that backdrop, adopting new technology can be just one more thing, and sometimes downright scary. We know it is hard, which is why we’ve designed our eConsent system for easy integration with sites’ existing processes, in our known and well-liked user interface, and on the devices sites are already using. Because “just one more thing” shouldn’t be a reason we hesitate to act.
We are at a point in our industry where we have a collective opportunity to challenge the status quo. It’s what we hear at conferences. It’s where COVID-19 has pushed us. And it’s what patients are demanding of us. eConsent provides a relatively low-risk opportunity to try a new way of doing consent that can improve the process for patients, can increase visibility and control for sites and sponsors, and can make compliance simpler.
1Walker, P. (2018, October 8). Econsent. MHRA Inspectorate. Retrieved 2022年5月27日, from https://mhrainspectorate.blog.gov.uk/2018/10/08/econsent/.
Good Clinical Practice Inspectors Working Group (GCP IWG). (2021, June 10). Draft Guideline on computerised systems and electronic data in 5 clinical trials. Amsterdam; European Medicines Agency. Retrieved 2022年5月27日, from https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/draft-guideline-computerised-systems-electronic-data-clinical-trials_en.pdf.
Learn more about how Suvoda eConsent and IRT can help your clinical trial.