Lessons learned from implementing eConsent to IRT integration

Experts shared their experience on the integration of eConsent to IRT, detailing the project’s journey, key steps, and takeaways.

At the IRT conference in Boston, Sara Liu, director, client delivery at IQVIA Technologies, and Sarosh Anjum, IRT system owner and lead, DigitalX, at Astellas, discussed a case study on their recent collaboration to implement both systems to achieve clinical trial efficiency and participant experience.

To successfully integrate eConsent to IRT, Anjum said they had to examine a multitude of different angles.

“At the end of the day, we wanted to get to a unified process. So in order to get through a unified process, we sort of broke it down. And the way I looked at it is that this is a new technology, eConsent, and it helps to support the overall trial experience,” he said.

To achieve this, a deep understanding of each technology, encompassing their full functionality, is needed, he added.

“It’s not just simply we’re going to put two pieces together, and it’ll work somehow,” Anjum said. He also noted the importance of collaboration among all stakeholders, including experts in eConsent, IRT, integration, and product owners.

Sarosh Anjum, IRT system owner and lead, DigitalX, at Astellas

eConsent-IRT workflow

Giving an overview of the workflow, Liu noted that the integration was one way - from eConsent to IRT. While integrated, both systems retain their core functionalities and business domain.

“We really want to make sure that we have the participant ID created and then pass through the IRT system consistently. And because these are still two different products, they still do their own domain business,” she said.

“And that’s really what the beauty of this integration is, is that we don’t really lose the basic functionalities for each,” she added.

Sara Liu, director, client delivery, IQVIA Technologies

The process begins with patient creation and consent recording within the eConsent system, according to Anjum, adding that the next step is the IRT system generates the subject number.

“And then once the patient and once the site is ready for the person to move forward, they confirm the demographic,” he continued. “Demographic entry is now the key for the EDC integration to kick off.”

Additional actions include data collected for combined reporting and automated decision making, participant randomization, and visits record and medication allocation, Anjum shared.

“The rest of the steps essentially are business as usual, but upfront we had to make sure that they’re all in synergy,” he said.

The why

“I think we’ve already heard a lot on why we are doing integration, and it’s just so obvious right now. We just have data everywhere,” said Liu. While eConsent may seem to have limited data points feeding into the IRT, its integration is necessary, she noted.

Liu further explained that case studies demonstrated evidence that integration improves efficiency, particularly during the build and maintenance processes.

“Ultimately, we really want to relieve the burden from the site and the patients for those inefficient technologies,” she said.

Liu added that she realized while going through the integration process that one of the big benefits was technology. However, she acknowledged the difficulty of deciding where to make updates when dealing with two independent systems.

“Quite often when you go through those integrations, and you realize that there’s something you want to update, and then decide whether it should be to the IRT, in the eConsent … With two completely independent technologies, sometimes it’s hard to make this decision,” she said.

Continuing the discussion on benefits, Anjum outlined three primary motivations for integrating the two systems from a sponsor’s point of view.

First, reduce patient burden. “The idea behind a robust eConsent implementation is that it does help the participant better understand what they’re signing up for,” he said. “It also ensures that if they do have questions, they’re able to funnel them in a nice productive way.”

Lessening patient burden also promotes an interactive reading experience, improved comprehension, and flexibility on how to complete consent, according to Anjum.

Second, support and move to decentralization, which includes consistent delivery of information across systems, comprehensive audit trail, and remote CRA monitoring. Anjum, however, noted that decentralization has a more forward-looking perspective.

“Decentralization is maybe more future looking or maybe how things were previously that it’s not always possible for all the folks involved in the consent process to be in the same place at the same time,” he said.

“With an eConsent solution, you can not only ensure that multiple systems are aligned, but if other folks that are doing remote monitoring, they can sort of look into it and see what type of questions the patients are having, what type of feedback the sites are giving.”

Anjum also emphasized that the integration helped unify the participant number.

“We wanted to ensure that once the consent is done— the site, subject, sponsor— we’re all referring to the same subject number across the systems. And by having the integration, it does give us that synergy,” he said.

Lastly, the benefits of eConsent, which Anjum explained, include increased compliance and improved patient retention, unified delivery of the informed consent form, improved data quality and availability, and efficient reporting for sites and sponsors.

“The benefit of eConsent, ultimately, if the patient is more informed, there’s less likely to be an early dropout,” he said.

Additionally, Liu added, “Quite often form consents are just pages by pages of paper. But with eConsent, participants can look at one particular paragraph, or if they have any questions, they can just ask, and the information is going to feed back into the CROs or monitors immediately.”

Refining and improving

Following the success of the eConsent and IRT integration, Anjum said refining and improving for the future were the next steps. A key step involves reflecting on the integration process. Anjum noted that both systems went live ahead on schedule, and that the aligned team was able to address issues as they emerged.

“Because we knew it was such a big deal that it was the new integration, it's a new methodology, we worked very closely with Sarah and her team to make sure we had folks available whenever we planned with clinical,” he said.

He added, “If anything popped up right away, we could look into it and say OK, let’s resolve it. Let’s not have a site impact.”

After the initial implementation, Anjum said their focus shifted to finding key learnings.

“We started talking about lessons learned because this is a brand-new thing. It’s a pilot study,” he said. “We want to reflect on what we’ve already done because we know we want to do it again.”

Quotes have been lightly edited for clarity.

Deposit Photos/Mazirama