Electronic consent in clinical research: overcoming the challenges of protocol amendments

Electronic informed consent (eConsent) tools are emerging as a valuable solution in the quest for a more patient-centric clinical trial experience. eConsent platforms take the complex paper consent document and turn it into a multimedia, interactive digital experience that translates the protocol into patient-friendly language and appeals to most learning styles to enhance patients’ understanding of their obligations – leading to better engagement and compliance. However, technology alone is not a panacea.

Creating and deploying eConsent will inevitably require an investment of time, human ingenuity and patience. Additionally, even after making this investment to design an optimized eConsent, unavoidable protocol changes must be handled within the platform, otherwise they could severely impede its functionality and delay ongoing or new patient visits. For this reason, organizations need to think about how to overcome the challenges to reap the full benefits of e-consent adoption.

The Challenge: Protocol Changes and Barriers to Paper-Based Informed Consent

Protocol changes are an integral part of clinical trials, yet they remain one of the leading causes of protocol deviations. After each change, each clinical trial participant is asked to review the protocol changes and renew their consent to the trial. Dealing with paper consent documents can naturally become a frustrating and time-consuming undertaking for participants. They will probably need to reread the informed consent form (ICF) in its entirety. When they do, detailed changes in protocol amendments can still be missed or misunderstood, leaving them with a lack of critical understanding or awareness of what the changes entail. This, in turn, could lead to participants not completely completing the required trial actions or giving up.

For example, many protocol deviations seen during inspections and audits stem from the patient consent process, such as:

• Missing signatures and dates in new consent ICFs

• Incorrect versions of ICF documents used for consent or new patient consents

• Participant’s new consent is not collected until receiving ongoing treatment or procedures

• ICF lost or damaged paper

The solution: implement eConsent

Thanks to eConsent, and with the support of experienced experts, when protocol changes are introduced, patients only receive the sections of the electronic informed consent form (eICF) that have been updated, saving them time time while mitigating the risk of miscommunication or misunderstanding.

Additionally, participants may have the option of completing the consent renewal process remotely, rather than traveling to the trial site to complete a hard copy. The eConsent system also ensures that all required fields and signatures have been completed. For new trial participants, the eConsent system will present the latest Institutional Review Board (IRB)-approved eICF, eliminating the risk of a patient completing an invalid version of the eICF.

On the trial site staff side, upon entering the eConsent platform, they will be presented with a simple dashboard with features to filter participants based on who is up-to-date on their consent forms . As this process occurs, external monitors have real-time access to patients’ consent status, a full audit trail of each consent, and the active eICF version of the patient’s consent site. ‘test.

Ultimately, considering the time spent and costs associated with managing and reviewing consent documents and deviations, and improving patient understanding and experience, eConsent obviously presents a positive return on investment.

Take on the challenge

It is undeniable that deploying a new technology in a complex clinical trial will require a significant time investment. Therefore, it is critical that the rollout of modified e-consent does not further extend this timeframe or delay ongoing or new patient visits.

The industry has seen a marked increase in the amount of protocol amendments. Previously, an amendment shut down the eConsent application and sites had to revert to a traditional paper-based process pending scanning and IRB/EC approval of changes. This inevitably caused unnecessary complications for site personnel by creating two processes to manage instead of just one. But today, it is essential that eICFs are equipped to remain fully operational even throughout these modifications.

By continuously refining e-consent systems and operational learnings, modified eICFs can be deployed efficiently to eliminate system downtime. New and improved eConsent platforms have been programmed from years of operational learning that allow the solution to efficiently deploy modified eICFs and eliminate system downtime.

Revolutionary Electronic Consent

While it’s hard to embrace change, digital clinical trials are the way of the future, and agile, comprehensive eConsent solutions have the ability to help sponsors and trial sites improve compliance and patient engagement.

Planning protocol changes early helps ensure well-organized and compliant consent procedures for patients, sites, and study teams worldwide. As eConsent solutions become increasingly popular among sponsors, it is likely that eICF IRB approval processes will become the new standard in clinical trial delivery processes rather than a challenge to overcome.

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