When it comes to gaining the benefits of electronic consent (eConsent) in clinical trials, site adoption is the key. Afterall, investigative sites are the link between pharmaceutical sponsor and patient. When a sponsor provides an eConsent solution to sites, they are enhancing the very important conversation that must take place between investigator and clinical trial participant, translating the protocol into patient-friendly language and learning modalities that help participants understand their obligations.

Without site staff commitment to using the technology provided, not only will trial participants continue to be presented with long, intimidating paper documents, but also sites will continue to struggle with compliance challenges associated with tracking a paper-based process for every consent and re-consent scenario.

Timing the Climbing

There’s no doubt that sites are the link to achieving a strong return on your eConsent technology investment, through reduced protocol deviations, higher patient recruitment and retention rates, and greater oversight. So at what point in the trial should we begin to focus on eConsent site adoption? During site activation? When a monitor notes that sites are experiencing challenges and resisting the technology?

During 2021 alone, IQVIA Technologies is supporting more than 5000 active sites and 35,000 active users of Complete Consent across more than 100 trials. Our experience has shown that eConsent adoption by sites is driven by two primary factors:

• Engaging sites early
• Engaging sites frequently

Establishing eConsent as your company’s standard practice in clinical trials requires all team members to provide the right guidance at the right time. But what does early and frequent site engagement entail?

Here are five key steps on the ladder to higher site adoption, as we strive to reach the highest levels of patient participation and safety, compliance, and efficiencies.

Step 1: Develop your country strategy for eConsent.

Electronic consent is a widely accepted technology, and its regulatory status should not be confused with the varying levels of acceptance of electronic signature by institutional review boards (IRBs) and ethics committees (ECs) around the world. As the IQVIA Complete Consent team meets with clients around the world, we continue to educate sites and sponsors that eConsent can be successfully deployed without eSignature.

The regulatory landscape for eSignature acceptance is rapidly evolving in this era of digital and decentralized clinical trials. For this reason, IQVIA Technologies maintains a global database of eConsent signature modality acceptance, country by country, region by region; and we update it continually with regulatory intelligence obtained through local study experience. We have engaged with over 55 country-level regulatory agencies to deploy eConsent and have gained a deep understanding of the types of questions and information required when reviewing eConsent acceptance. As your technology partner, we provide guidance to ECs and sites on their eConsent discovery journey, setting your deployment up for success at the earliest point with an eConsent signature modality country strategy.

Step 2: Include eConsent in trial planning.

A sponsor’s commitment to eConsent success begins at trial planning. We recommend inclusion of the topic in your site-selection questionnaires and visit checklists to identify any challenges to eConsent adoption with respect to experience, patient population, SOPs, technology, and connectivity. Sponsors should clearly convey to potential sites that eConsent is the established and expected method for consenting patients and share information to demonstrate how it will benefit them and their patients. IQVIA Technologies provides its clients with guides that include recommended questions and topics for discussion.

Step 3: Optimize your informed consent form digitization timelines.

Traditionally, the creation of the electronic informed consent form (eICF) would not take place until approval of the paper ICF per country/site was received. With Complete Consent, IQVIA Technologies takes advantage of an optimized submission strategy, through which we begin ICF digitization in parallel with the paper ICF approval process. This approach enables us to be ready to start consenting patients by the site initiation visit (SIV), a critical rung in the ladder to higher eConsent site adoption. When sites are trained and confident to start consenting electronically from the first patient visit, we see them embrace the technology and the benefits it brings.

Step 4: Train and communicate.

Once site selection is complete and site initiation begins, eConsent should be included in all communications and trainings. The IQVIA Investigator Site Portal (formerly known as DrugDev) has proven to be an ideal platform to help with this step. It includes Site Engagement, Learning Management, and Document Exchange modules that are used and loved by hundreds of thousands of site personnel. The platform is so intuitive that additional training is never required, and single sign-on with IQVIA Complete Consent is available.

With Complete Consent, helpful guides and videos are available as flexible references to sites. We also provide materials to support monitors when discussing eConsent with site staff, including a checklist of items to be covered during the site initiation visit. A robust site adoption escalation pathway will quickly reveal any unidentified challenges that arise throughout site selection and study conduct.

Step 5: Build a monitor advocacy program.

Once a site has been successfully activated, it is important to continue to engage with staff regarding their use of eConsent so that the efficiencies of the system in consenting, reconsenting and remote monitoring are realized. To help, IQVIA Technologies provides its clients with a comprehensive list of Complete Consent-related tasks to be included in the clinical operation strategy and site monitoring plans.

CRAs are on the “front line” with sites, and usually are the first to detect if a site requires extra support. We recommend that you identify and train a team of eConsent subject matter experts who can be advocates for CRAs and ensure that your monitoring teams are aware of all the materials, training and support available to them.

Conclusion

Timely response to site queries, with escalation to eConsent specialists when required, is critical for successful site adoption; but don’t wait until site activation to introduce the technology. Position your commitment to eConsent with sites as you plan your study, allowing you to identify potential roadblocks and handle them early.  Then be sure to engage site staff often, from site selection through to study close out.

As you repeat these steps up the ladder of eConsent adoption, you’ll reach new heights with every study.