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eConsent Initiative

A multistakeholder initiative to harmonize terminologies and study documents needs on various aspects of eConsent, to increase insight in different stakeholders’ value models and country needs, and to provide a fit for purpose eConsent study framework.

eConsent Initiative

Chairing Hilde Vanaken
What is eConsent?

The informed consent is a process between participant and site personnel – the two key players – but the sponsor and other parties also have important roles to drive, support, and verify the accuracy of the process.

The term ‘eConsent’ is the overarching terminology for the traditional informed consent process supported by one or more digital features (e.g. tiered content, glossary, quiz). There are many different eConsent models, and it is important to understand that the consent process does not change, the same consent process steps are still applicable, as shown in Figure 1.

Figure 1: eConsent Definition and Some Examples of eConsent Digital Features

There are many disconnects regarding eConsent with some misconceptions as outlined in Figure 2. For example, eConsent is often confused with remote consent but they are two different concepts. Remote consent refers to the location of the participant and investigator during the consent process and that they are not in the same physical location. A remote consent process could be conducted entirely on paper (not eConsent) or by using digital features (eConsent).

Figure 2: Some Common eConsent Misunderstandings

Enabling clinical trials access to anyone, anytime, anywhere starts with the consenting process. Using digital features to support the consenting process can benefit all stakeholders involved but eConsent deployment needs to be driven from a stakeholders’ value, not technology perspective, and challenges need to be addressed proactively.

There is no one size fits all eConsent: each indication, each study, each study population, each site and each participant might have different needs.

Our Mission

The EFGCP eConsent initiative is a non-profit multistakeholder initiative involving Pharmaceutical companies, Vendors, Academic Institutes, Participants, Sites, Ethics Committees and Health Authorities.

The main deliverable is the creation of practical tools and recommendations aimed at harmonizing eConsent terminologies, study document requirements, and implementation methods. This will enable the development of the right eConsent strategy for a particular study.

Each stakeholder group will drive their value models and enable awareness and education within their community.

Our Workstreams

The initiative is divided into multistakeholder workstreams (Library, Study Documents and Database Workstreams) and individual stakeholder workstreams (Pharma, Vendors and Academic Institutes Workstreams). Over 50 leading organizations, featuring several world-renowned eConsent leaders, joined one or more workstreams.

The focus of each workstream is detailed below:

  • Library Workstream: to define harmonized terminologies to describe various eConsent digital features, platform and operational aspects.
  • Study Documents Workstream: to define a harmonized overview of which eConsent aspects should be described in specific study documents and to what level of detail.
  • Database Workstream: to provide insight into local needs of specific eConsent aspects.
  • Pharma, Vendor and Academic Institutes Workstreams: to provide insight into individual stakeholders’ needs, challenges and value drivers, and guidance on how to measure and generate impact.

Other stakeholders (Participants, Sites, Ethics Committees and Health Authorities) are involved on an ad hoc basis for input and when appropriate.

Close alignment between workstream is handled by the governance team, comprised of the different workstream leads and the chair.

Resources and Publications

Feedback

If you have any questions or feedback on the tools, articles, event recording or external references listed below, please click here.

Disclaimer

The information provided on this website is for informational purposes only and does not constitute legal advice; for specific legal matters, we strongly recommend consulting a qualified legal expert.

Publication or use without crediting the EFGCP eConsent Initiative and Hilde Vanaken, or commercial use of any of the Resources available below, even partial or modified, is strictly forbidden without authorisation.

Tools

Articles

Event Recording

External References

EFGCP eConsent tools are being referenced in other documents, e.g.,

  • eConsent Study Documents Recommendations in the Positioning Paper of Decentralized Clinical Trials with Medicinal Products in Switzerland from SwissMedic and SwissEthics published on 10 February 2025: External Link
  • Glossary of eConsent Terms, eConsent Study Documents Recommendations, and eConsent Fit-for-Purpose Study Framework was added as a resource to several Decentralized Clinical Trial Process Steps of the DTRA (Decentralized Trial Research Alliance) Playbook/TubeStop: External Link
Where are we?
2024 - December
On 10 December, a public webinar titled “eConsent: What It Is, What It Isn’t, and Tools to Implement” showcased the deliverables of the European Forum GCP eConsent initiative. The event drew nearly 400 registrants, with 180-200 attendees joining live. Participants represented a wide range of organizations, including pharma companies, vendors, ethics committees, academic institutes, health authorities, patient organizations, among others. The webinar received very positive feedback. Now, it’s in the hands of the industry to adopt these tools and bring eConsent to the foreground where it belongs. Webinar presentation and recording are available in the resources.
2024 - October
The Database Workstream has published the results of the eConsent Ethics Committees (ECs) and sponsors/vendors perspectives and experiences in Applied Clinical Trials on 11 October. 49 Ethics Committee Respondents of 15 different countries completed the eConsent ECs survey, and 42 respondents the sponsor/supplier survey with 67% sponsor and 33% vendor respondents. The survey results reveal some interesting insights into Ethics Committees’ perspectives and expectations on topics such as 1) minimal signature requirements for on-site, remote with video call, or remote with phone call interactions between investigator and participants, 2) personal data hosting requirements, 3) important factors for approval, among many other items. Interestingly, the regional difference between ECs may not be as significant as often assumed. On the sponsor (commercial, non-commercial) and vendors (technology, CRO) side, the surveys examined drivers, barriers, usability of digital features, and other aspects. While common viewpoints were shared, there were also notable differences between both organizational types. Highlights have been covered in the article “Understanding Acceptability of eConsent from a Global, Ethical and Industry Perspective” published by Applied Clinical Trials and the detailed survey results can be accessed through the supplemental information section of the article.
2024 - August
The Pharma Workstream, in close collaboration with other workstreams, has finalized the eConsent Fit-for-Purpose Study Framework. This tool provides sponsors (and any stakeholder interested in eConsent) a guide on how to define and design the right eConsent for a particular study and how to generate effective and comparable study data on eConsent. Potential eConsent benefits and challenges of participants, sites and sponsors; or impact of various eConsent platform and operational aspects on targeted benefits, or potential eConsent Key Performance Indicators with qualitative and quantitative measurement approaches, are just some of the items detailed in this 5-process step framework. Highlights have been covered in the article “Effective eConsent Strategies for Every Study: Utilizing the eConsent Fit-for-Purpose Framework” published by Applied Clinical Trials and the entire framework is available in the Resources.
2024 - July
The Library Workstream has made updates to the glossary to be consistent with the Fit for Purpose eConsent Study Framework.
2024 - July
The Study Documents Workstream has released its recommendations on which eConsent Platform and Operational Aspects should be described in nine different study documents: Protocol, Health Authority and Ethics Committee Submission Cover Letter, Participant-related eConsent Documents, Informed Consent Document, Site eConsent Documents, Monitoring Plan, Data Management Plan and Platform/Vendor Due Diligence Documents.
2023 - December
The Library Workstream has finalized a first of its kind Glossary of eConsent Terms, which incorporates the former glossary of eConsent Digital Features. Having harmonized terminologies to describe the platform and operational aspects of eConsent is critical to eliminate misconceptions and to enable transparency and a common understanding between all stakeholders. In addition, the glossary can serve as a general knowledge base of key aspects to consider when deploying eConsent. Highlights of the glossary has been covered in the article “eConsent – Why Language Matters” published by Applied Clinical Trials and the entire Glossary of eConsent Terms is available in the resources.
2023 - November
The Study Documents Workstream has published the results of the eConsent Ethics Committees (ECs) and Health Authorities (HAs) Submission Documents in Applied Clinical Trials on 13 November. 62 organizations completed the ECs submission documents Survey, 58 organizations the HAs submission documents survey. Both surveys contained 28 questions, addressing various eConsent Platform and Operational Aspects. Objective was to get industry’s perspective whether EC (or HA) should be informed about (or not) and why, where it should be reported, and whether EC (or HA) should approve. Highlights have been covered in the article “Navigating eConsent Submission: Who, What, Where and Why” published by Applied Clinical Trials and the detailed survey results can be accessed through the supplemental information section of the article.
2023 - August
The Database Workstream launched two surveys to get a better insight into experiences, perceptions and expectations of Ethics Committees and sponsors/vendors on the use of eConsent and specific eConsent aspects.
2023 - April
The Study Documents Workstream launched two surveys to get industry’s perspective into what Health Authorities and Ethics Committees should be informed about (or not), their rationale, in which study documents it should be described, and whether they should approve or not.
2022 - November
Kickoff meetings of the individual workstreams took place in the week of 14 November. Biweekly meetings were initiated to prepare the first draft material.
2022 - October
Follow-up meetings were held in October to collect feedback and to finalize workstream members and co-leads assignments for the 6 different workstreams: Library, Study Documents, Database, Pharma, Vendor and Academic Institutes workstreams. Over 20 leading Pharmaceutical companies, 20 leading vendors and 10 Academic Institutions signed up from one or more workstreams.
2022 - September
+100 participants of +70 different organizations joined the kick-off meeting on 22 September where the overall design, deliverables, workstreams and roadmap were presented for their input. Representatives were from Pharmaceutical companies, Vendors, Academic Institutes, Patients, Sites, Ethics Committees and Health Authorities. Excellent feedback was received and workstream nominations were initiated.
Conferences, Webinars, Interviews
  • 2025 - Decentralized Trials & Research Alliance (DTRA) Session on eConsent Suite of Tools on 29 January: On 29 January, EFGCP eConsent was invited to present and discuss the eConsent suite of tools at Decentralized Trials & Research Alliance (DTRA). A recording of the TGIF DTRA session on “Demystifying eConsent - the European Forum GCP eConsent Suite of Tools” is publicly available on LinkedIn.
  • 2024 - Clinical Outsourcing Group Europe on 13 November in Amsterdam: Presentation highlighting all deliverables of the European Forum GCP eConsent initiative, titled “Unveiling the European eConsent Fit-for-Purpose Study Framework for Clinical Research” to a full audience of emerging biotech companies. Click here for more information https://www.thepbcgroup.com/cog-europe
  • 2024 - Scope Summit Europe on 30 October in Barcelona: Presented “Redefining eConsent: From Misconceptions to Clarity” introducing the mission of the European Forum GCP eConsent initiative, the different workstreams and the suite of tools developed. Click here for more information https://www.scopesummiteurope.com/
  • 2024 - SCDM (Society Clinical Data Management) Annual Conference on 30 September in Boston: Presentation on “Unraveling all Disconnects, Misconceptions and Uncertainties about eConsent: European Forum GCP eConsent Initiative” as part of the panel session “Navigating the Future of Informed Consent: Implementing eConsent in Clinical Trials”. Click here for more information https://scdmlive.org/ac2024-programme/
  • 2024 - International QA Virtual Conference on 22 May: Presentation on “eConsent – A Quality-Driven Perspective” and sharing insight in EFGCP eConsent activities with a focus on quality aspects. Click here for more information: https://www.therqa.com/learn-develop-connect/courses-and-events/conferences/rqa2024-virtual/programme/
  • 2024 - European Patient As Partners conference on 15 May in London: Presentation on “eConsent Transformation: Putting Value First” and sharing insight in EFGCP eConsent activities and the upcoming eConsent Fit For Purpose Framework. Click here form more information: https://patientsaspartnerseu.com/agenda?page=2
  • DIA Europe Conference on 14 March 2024 in Brussels: Presentation on “Bringing eConsent to the Place it Deserves Through Harmonization and Insight in Value Models. Click here form more information: https://www.diaglobal.org/en/flagship/dia-europe-2024/about/conference
  • 2023 - European Site Solution Summit (SCRS) on 14 November in Portugal: Sharing insight on EFGCP eConsent activities as part of a panel session on “Exploring Practical Examples of Decentralized Elements”. Click here form more information: https://eusitesolutionssummit.com/sessions/breakout-session-iv/
  • 2023 - Vaccelerate Webinar on 5 July Presentation on “eConsent - Chances and Challenges for a Multistakeholder Community”. Click here for a recording of the webinar: https://www.youtube.com/watch?v=QvYh9LDj1xc
  • 2023 - Interview by Applied Clinical Trials on 29 June in Boston: Interview about EFGCP eConsent Initiative activities at the Global DIA Annual Conference. Click here for a recording of the interview: https://www.appliedclinicaltrialsonline.com/view/dia-2023-what-is-the-european-forum-gcp-econsent-initiative
  • 2023 - Global DIA Annual Conference on 28 June in Boston: Presentation on EFGCP eConsent initiative activities as part of the panel session “Industry and Regulators’ Experience with Implementation and Use of Remote and Electronic Consent”. Other session speakers were FDA and MHRA, with Roche as chair. Click here for more information: https://www.diaglobal.org/en/flagship/dia-2023/program/schedule/agenda
  • 2023 - ECRIN International Clinical Trials Day (ICTD) on 23 May in Poland: Presentation on “eConsent: not a one size fits all” and introducing EFGCP eConsent initiative. Click here for a recording of the session: https://ecrin.org/videos/ictd-2023-e-consent-not-one-size-fits-all-hilde-vanaken
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