In 2019, a team of industry experts formed a task force to examine challenges and opportunities in the adoption of electronic informed consent (eConsent) in clinical trials. The joint task force, consisting of members from the European CRO Federation’s (EUCROF) New Technologies working group and the eClinical Forum (eCF), sought to answer the question why, despite the wide availability of eConsent solutions and obvious benefits for all stakeholders, isn’t utilization of these digital tools more widespread? The collaboration culminated in the publication of their first eConsent Implementation Guide in 2021, a comprehensive reference resource intended to help clinical research sponsors and regulators understand nuances and considerations involved in the implementation of eConsent. Co-chaired by Fiona Maini, principal – global compliance and strategy at Medidata Solutions, and Mika Lindroos, director of product management – eConsent at Signant Health, the team is now a finalist for The Organisation for Professionals in Regulatory Affairs’ (TOPRA) Innovation Award.

 

The TOPRA innovation award recognizes new processes, methods, or research delivered in the past three years that provides “interpretation in a complex regulatory situation,” in addition to other criteria. The eConsent Implementation Guide examines the current state of regulatory acceptance around the world, the impact of COVID-19, as well as offers recommendations to ensure data protection and privacy. In addition, the guide offers:

  • An overview of eConsent, definitions including discussion around interactive education, signature components, as well as remote and on-site options
  • Stakeholder perspectives: How eConsent can improve patient experience and advance the consent process for sponsors, sites, CROs, third parties, and authorities.
  • How COVID-19 has accelerated the use of eConsent, and demonstrated its value
  • Detailed guidance and a roadmap for the implementation of eConsent

The latter point is examined in the most detail. The paper provides a comprehensive implementation roadmap outlining all major steps of eConsent deployment. Beginning with vendor selection, it offers eight recommendations for selecting a solution and provider, then transitions to the regulatory factors that should be considered. Next, the guide proposes best practices for kick-off preparation, change management planning, and eClinical systems integration requirements. Finally, the task force delivers expert insights into security assessments, configuration, regulatory approvals, and training considerations. Readers can visualize this process and key decision points in a helpful timeline infographic.

In response to the nomination and naming as a finalist for the award, Mika Lindroos commented, “Our intent in creating this eConsent Implementation Guide was to equip sponsors and regulators with comprehensive information extending beyond just features and benefits of eConsent solutions. We offer a macro-level overview of the current landscape as well as deep dives into processes and nuances encountered when transitioning to eConsent. This award nomination underlines the significance of the issues we discuss and guidance we offer in this paper.”

Adding to that sentiment, Fiona Maini commented, “We want sponsors to understand what to expect and how to navigate the journey so the transition to electronic informed consent is smoother and more efficient. From the regulatory perspective, we detail how eConsent addresses compliance and data security considerations, and we look at how countries have updated guidance in response to COVID-19 so researchers have a resource to refer to during the implementation process.”

Winners of the TOPRA Innovation Award will be announced on 18 November 2021. The eConsent Implementation Guide is available for download here

For more information, contact the eConsent Task Force Implementation Co-chairs Fiona Maini (fmaini@medidata.com) and Mika Lindroos (mika.lindroos@signanthealth.com).

Signant Health

Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently generate quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 20 years, over 400 sponsors and CROs of all sizes – including all of Top 20 pharma – have trusted Signant Health solutions for remote and site-based eCOA, eConsent, IRT, supply chain management, and data quality analytics.

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