In a recent article, I shared five steps to achieve greater eConsent adoption by clinical research sites:

Step 1: Develop your country strategy for eConsent.
Step 2: Include eConsent in trial planning.
Step 3: Optimize your informed consent form digitization timelines.
Step 4: Train and communicate.
Step 5: Build a monitor advocacy program.

Many found the article helpful and had further questions around the topic of handling protocol amendments in an eConsent deployment. Some had found that eConsent lacked the agility necessary to make quick changes to the electronic informed consent form (ICF) when protocol amendments occurred. Thus, I’d like to share some insights our team at IQVIA has gleaned from our experience deploying eConsent on diverse trial types around the world.

Addressing protocol amendments in an eConsent solution is of critical importance to the industry for two paradoxical reasons:

• There are key challenges to overcome
• There are significant benefits gained once those challenges are addressed

Let’s start with the benefits first to be sure we have the motivation to overcome the challenges!

Benefits from eConsent in handling protocol amendments

Protocol amendments are inevitable; and unfortunately, they are one of the greatest sources of protocol deviations in a trial. Every time a protocol amendment occurs, each clinical trial participant must consent to the change. This can become frustrating to the patient, because in the paper world, they often need to re-read and re-sign the paper ICF, and changes may be missed in the large document and therefore not fully understood.

Many of the deviations uncovered during audits and inspections come from the patient consent process, such as:

• Participant re-consent not collected prior to receiving ongoing treatment or procedures,
• Incorrect version of ICF documents used for reconsent, or new patient consents,
• Lost or damaged paper re-consent ICFs,
• Signatures and dates missing from re-consent ICFs.

Electronic Consent solves these problems

With IQVIA Complete Consent, patients are presented only the areas of the eICF that have been amended, saving time, and eliminating confusion and frustration. The participant and physician can focus their attention to improve comprehension and ensure participant comfort with the change.

The site staff will be presented with a simple dashboard where they can filter on those participants that need to reconsent, and patients could have the option of completing the re-consent process remotely without having to travel to the sites.

For new participants, the system will always present the latest IRB approved eICF, eliminating the risk of consenting a patient to an incorrect version.  In addition, the system inherently ensures all required fields and signatures are captured.

Throughout this process, monitors have real-time access to the current consented and reconsented status for patients; a full audit trail of each consent; what eICF version the site has active via a preview across all their sites at the click of a button.

IQVIA Complete Consent case study: In this Global phase 2 Oncology trial set the objective to reduce consent-related protocol deviations from their portfolio from an average of 15% to 9%. When Print-to-sign modality was used this reduced to 6%, when the full digital eSignature modality was used, deviations were reduced to 1%.

When you equate the number of hours and costs associated with managing and reviewing the consenting documents, and deviations, combined with the improved patient experience and comprehension the return on investment for eConsent is clear.

Challenges to overcome

Now that we understand the benefits, let’s talk about the real-world challenges. Producing and deploying an electronic version of the ICF involves creative, educational, and technical processes. There’s no getting around the time it takes to produce a patient experience that makes a difference. Yet, it’s critical that amended eICF deployment does not delay ongoing or new patient visits.

The industry has experienced a drastic increase in the volume of protocol amendments. Historically, an amendment would shut down the eConsent application and sites had to revert to a traditional paper process while waiting for the digitization and IRB/EC approval of the changes. This caused unnecessary complications for site personnel by creating two processes to manage instead of one.

That’s why when we developed IQVIA Complete Consent platform in Dec 2020, we distilled over 15 years of eConsent system and operational learnings to enable us to efficiently deploy amended eICFs and eliminate system downtime. Now, at the click of a button, we can generate IRB submission packages in less than a minute.

A new era of eConsent

Change is challenging, but the evolution to digitally enabled clinical trials is well underway, and agile, feature-rich eConsent solutions can help sponsors and sites drive better patient engagement and improved compliance.

At IQVIA Technologies, we work with our customers to begin the digitization and translation of the paper ICF while it is being reviewed by ethics committees and regulators. We plan for protocol amendments upfront to better ensure a well-orchestrated, compliant consenting processes for sites, patients, and study teams across the globe.

As we continue to see the growing adoption of eConsent as sponsors realize the benefits it brings to participants and clinical trial conduct, I predict that the eICF IRB approval process will become a new normal in clinical trial delivery processes, rather than a challenge to overcome.