Clinical Researcher—July 2021 (Volume 35, Issue 5)

SITES & SPONSORS

Bree Burks, RN, MSN

 

How can research site staff manage patient consent efficiently if they are required to use a different system for each study? Learning and using multiple consenting solutions is difficult and adds complexity to research operations, leading sites to rely on manual processes that can delay trials. There is, however, a better way to manage informed consent, and positive change is happening across life sciences because of it.

New electronic consent (eConsent) solutions are transforming the experience for both sites and patients by allowing staff to break free from administrative tasks and patients to provide informed consent from the comfort of home. More investigators are standardizing consent processes across trials by adopting eConsent solutions built specifically to address the challenges sites face every day.

If you need to streamline informed consent for your next study, here are five key considerations to help select the right eConsent solution.

Put the Patient First

Patients participating in trials carry a heavy burden, traveling long distances and investing hours at sites to review consent documents. Because of the time commitment, some patients rush through the review process leading to issues with comprehension. eConsent elevates this experience by simplifying document access and review and enabling customized experiences based on the patient’s unique needs. Empowering patients with the ability to access study documents anywhere, anytime also provides the flexibility to complete consent from the comfort of home and with family or caretakers if needed.

Your eConsent should seamlessly work together with patient-facing applications designed for virtual visits, electronic patient-reported outcomes, and messaging. As more patients interact with clinical trial technology, the objective should be to provide one tool for all engagements.

In addition, eConsent should deliver an easy and intuitive user interface that helps patients navigate and complete the informed consent process. Enabling digital consenting is more convenient for patients and improves the experience of participating in a study.

Identify an eConsent Solution for All Studies

Using a different patient consent solution for every trial isn’t optimal because of staff access and usability issues. Every system includes distinct processes and requirements, and the slightest deviation leads to compliance risk. This is a significant challenge for sites as research teams struggle to implement standard operating procedures for consenting when there is so much variation across systems. Selecting a solution that can be used for all studies enables the standardization that drives greater site efficiency and improved study quality.

Ensure the System is Validated

Many sites do not have big budgets or large information technology teams to validate eConsent solutions independently, making validation a critical part of the technology evaluation process. Consider a solution that comes validated for use out of the box. In addition, choosing a system that offers seamless, validated upgrades can ensure ongoing global compliance for sites.

Find the Right Partner

Since you will be replacing previous consenting methods such as wet signatures and study binders with a digital solution, identify a provider with proven expertise at working with investigators. Partner with a technology company that has a reliable history of customer success and is dedicated to innovation. Because of the critical work sites are doing to advance patient health, good isn’t enough for technology partnerships—you need great.

Connect Across Systems and Workflows

Prioritize eConsent solutions that connect to existing systems and workflows because they enable faster trial execution. For example, if the solution integrates with an investigator site file, processes can be automated, easing the burden of printing, scanning, and filing paper documents.

The solution should also enable seamless information sharing with sponsors and contract research organizations. This would improve trial oversight and ensure compliance for sponsors while allowing sites to work faster and in a more cost-effective way.

Conclusion: The Shift to Digital Patient Consent

There is no need for research sites to use multiple consenting systems and workflows in trials for different sponsors. eConsent solutions are available now that consider the barriers sites face while completing patient consent, standardizing processes and speeding study execution.

Using a site-first, validated solution means that investigators can digitize the consent process for patients while delivering transparency and visibility to sponsors. By having an eConsent solution that connects to other systems and works across all studies, sites can rest assured that they have the right technology in place to handle any patient consent requirements.

The simple truth is that long forms and legacy systems are no longer sustainable ways for sites to work. To keep up with the requirements of today’s clinical trials, patients should be consented using digital, connected solutions. Streamlining and automating informed consent frees up staff, allowing them to shift focus from performing daily administrative tasks to delivering exceptional patient care.

Bree Burks, RN, MSN, (bree.burks@veeva.com) is Vice President, Site Strategy for Veeva Systems. She has more than 12 years of academic medical research experience supporting hundreds of trials spanning all translational stages in sponsor and site settings.