Clinical Researcher—August 2026 (Volume 40, Issue 4)
PEER REVIEWED
Amanda Zenere; Amber N. Hood, DFS, MS, CPIA, CIP; Candida Barlow, PhD, MSN, CRN-BC, RN; Catherine Gregor, MBA, CCRP, CCRC; Istvan Feteke; Kamila A. Novak, MSc; Katherine Leibowitz, JD; Megan Solomon, LPN; Spencer Phelps; Andrea Bastek, PhD
The electronic informed consent (eConsent) working group of The League, a Florence Healthcare initiative, has developed a high-level framework for defining and measuring the impact of eConsent usage at clinical trial sites. This article outlines key success indicators, relevant metrics, and practical steps the industry can take to begin assessing the real-world impact of eConsent on site operations. As eConsent adoption matures, this high-level framework can evolve into a more complex key performance indicator (KPI) infrastructure. A companion article in this same issue, “Envisioning eConsent Success (Part II): Laying Out a Global Interoperability Blueprint for eConsent,” focuses on a technology-agnostic integration blueprint that considers both sponsor-deployed and site-owned systems, and prioritizes both operational feasibility and reduction of duplicate workflows at study sites.
Background
In the clinical trials industry, adoption of eConsent is often reported as being in the range of 50% to 75%.{1–3} The stated benefits of eConsent typically include improved patient engagement and operational efficiency.{3} The eClinical technology landscape is both vast and complex, with more than 60 vendors offering solutions, which also suggests high adoption and a saturated market.{4} However, anecdotal evidence suggests that these adoption numbers may be inflated; it is commonly reported by panelists at industry conferences, in virtual roundtables, on webinars, and among the eConsent working group members that the rate of real-world experience with eConsent is actually very low.
Further, several large multi-stakeholder eConsent initiatives highlight the limited guidance available for effective implementation as well as misconceptions and disconnects in the industry,{5,6} also suggesting that adoption is lower than reported. However, there has been U.S. Food and Drug Administration (FDA) support for eConsent usage since 2016,{7} and more recent global regulatory guidance and support,{8,9} so no obvious regulatory hurdle is preventing industry adoption.
The reality is that eConsent adoption and implementation remain fragmented. {10,11} The European Forum for Good Clinical Practice (EFGCP) explains this fragmentation as follows: “There is no one size fits all eConsent: each indication, each study, each study population, each site, and each participant might have different needs.”{6}
Sponsor eConsent usage and vendor selection vary by study phase, size, and geography, as well as sponsor/contract research organization (CRO) preference and various other factors. Sites considering purchasing or using sponsor-provided eConsent must consider their existing technology infrastructure, staff experience, sponsor relationships, institutional review board (IRB) policies, and evolving regulatory requirements, such as the validation requirements in the ICH E6(R3) guideline for Good Clinical Practice (GCP) from the International Council for Harmonization.
Sites also report that they sometimes receive sponsor-pushback on the use of eConsent. All stakeholders face hurdles such as information technology (IT) review time, change management, platform cost, and concerns about integrating eConsent into existing workflows.{12} Sponsors and CROs face similar challenges to adoption and implementation, and must also consider global regulatory compliance to ensure consistency across study sites.{11,13} These challenges have blunted eConsent adoption and implementation and resulted in fragmented usage of the many vendors across studies in the industry.
As a result of the industry fragmentation, there is no standard measure of eConsent success. Many assessments of eConsent success focus on participant-centric metrics, like comprehension, satisfaction, and retention.{14–17} These metrics are critical to understanding the participant experience, but do not evaluate the operational impact and burden at the site level, where implementation and usage are critical to any measure of participant success.
The industry lacks a unified approach to understanding and assessing site impact, which directly affects eConsent adoption and success. The eConsent working group of The League wanted to address this industry gap, and as such worked to develop a high-level framework for defining and measuring the impact of eConsent usage at clinical trial sites.
Deployment Model Definitions
The users of eConsent systems are always site staff and participants, but there are two different models for which stakeholder provides the system: site-owned or sponsor-deployed. The deployment model being used in a specific setting and/or for a specific trial affects the operational impact of the systems in play, and so must be defined and understood first.
Site-Owned: A site may invest in an eConsent system as a platform for use across its study portfolio. This system would be managed and supported by site staff, integrated into site standard operating procedures (SOPs), work instructions, and IRB approval processes and used across many studies contracted by various sponsors or CROs. Sites are responsible for the informed consent process and should be able to conduct this process using any tool that complies with all regulatory requirements, but sponsors/CROs have an obligation to confirm that the site-owned system is fit for purpose, validated, and compliant with data privacy standards and other regulations. The sponsor and IRB would also need to approve any site-created study content used in the system. In some cases, sponsor regulatory or logistical concerns result in the parties foregoing eConsent usage.
Sponsor-Deployed: A sponsor/CRO may contract with an eConsent vendor to provide eConsent to sites for a specific study. This system would be managed and supported by the sponsor/CRO, with access provided to site staff for the study. Sites and principal investigators (Pis) retain ultimate responsibility for informed consent oversight and documentation, so sites may need to update their consent processes or SOPs to include eConsent as an option. Site IRBs may need to develop a new approval process for eConsent used in this situation. Sites may need to determine how to satisfy their own regulatory requirements for consent documentation and record retention when using sponsor-deployed eConsent for a study.
In both deployment models, it is important to remember that consent methods for a study will likely still include both electronic and paper consents, as participant preference may vary across individuals and study timepoints, and may even include both electronic and paper consents at different time points for the same participant. The chosen consent method can vary depending on the participant’s preferences, technology access and fluency, and convenience at any given time. Hybrid workflows require sites to maintain and reconcile eConsent and paper tracking and final document storage procedures, which will vary in complexity depending on the deployment model and can increase the site’s administrative burden.
Deployment Model Implications
The operational impact of eConsent on study stakeholders can differ depending on whether the system is site-owned or sponsor-deployed, and understanding those differences is critical to planning integrations and considering success metrics. In Table 1, the working group documented the details and implications of eConsent across different dimensions for each deployment model, primarily from the site perspective.
Table 1: Details and Implications of eConsent in Different Deployment Models
| Site-Owned | Sponsor-Deployed | |
| Purchaser | Site ——————————————- |
Sponsor/CRO ——————————————- |
| Study usage
|
All/most site studies across many sponsors/CROs
——————————————- |
Single study usage (possibly across multiple studies from the same sponsor, or from different sponsors/CROs if the same vendor is chosen) ——————————————- |
| System Training
|
Consistent across studies; internal training reused ——————————————- |
System differs by study; new training each time ——————————————- |
| Workflow Alignment
|
Tailored to site SOPs and existing systems
——————————————- |
May require parallel or duplicative processes and/or changes to SOPs or new SOP creation; may cause a workflow conflict when a site-owned eConsent is in place ——————————————- |
| Tech Support
|
Managed by site/vendor; more direct and expedient communication and support ——————————————- |
Dependent on sponsor/vendor; point of contact may be unclear (sponsor, CRO, vendor) ——————————————- |
| System Content
|
Site is responsible for creating/uploading consent documents and must coordinate with sponsor if content needs to be approved; site must ensure local IRB and institutional requirements are met ——————————————- |
Sponsor may load consent documents/content in the system but must coordinate with sites to ensure template documents are customized for the site and any local language and IRB requirements are met ——————————————– |
| Version Control
|
Site staff control, maintain, and update the consent version in a repeatable process when protocol amendments occur or consent form changes are required ——————————————- |
Sponsor may need to create/load the newest IRB-approved version in the system; delays in getting new versions active in the system can force sites to revert to paper or delay enrollment ——————————————– |
| IRB and Regulatory Considerations
|
Sponsor may want to approve usage of the tool; sponsor and IRB must approve any study content the site creates for use in the system
——————————————- |
Site needs to ensure SOPs support use of this tool and that consent process requirements are satisfied; IRB needs to review the patient interface; adds a compliance risk by having different process for studies using this tool rather than the standard site SOP ——————————————– |
| IT/Security/Data Privacy Review
|
Centralized validation and data privacy controls
——————————————- |
New IT/security and data privacy review needed for each study/vendor ——————————————– |
| Cost Model | Higher upfront cost; potential long-term return on investment (ROI) ——————————————- |
No direct cost to sites, but higher hidden labor burden and change management barrier ——————————————– |
| Audit Readiness | Unified document access and version control ——————————————- |
Variability across studies; fragmented tracking ——————————————– |
| Integration Strategy
|
Integrations to other site systems would be repeatable, but must be funded by the site; integrations to sponsor systems unlikely to be supported ——————————————- |
Integrations to other sponsor systems might make sense and would be funded by the sponsor
——————————————– |
Note: This framework is designed to help stakeholders understand the implications of the different deployment models and is not a recommendation for or against either deployment model.
Defining Success for All Stakeholders
The first step in defining success metrics is understanding what success means for the various stakeholders involved in the process, regardless of deployment model. In Table 2, the eConsent working group analyzed the process of using eConsent to document a draft list of success criteria. Of course, this list is not exhaustive and each stakeholder should consider their own process and unique success criteria. This framework intentionally omits participant-facing metrics to focus on the site operational experience for all formats of eConsent.
Table 2: Stakeholder Perspectives on Operational Success
| Stakeholder | Success Criteria |
| Clinical Research Coordinator (CRC)/PI/ Regulatory Staff | ● Reduction in consent-related deviations due to technology features and support, no technology-related deviations
● Decrease or no increase in duplicate data entry or manual process steps ● Ability to manage hybrid consent models where some participants may require paper consent ● Clear SOP alignment ● Timely updates to consent content in the system when protocol amendments or consent form changes occur ● Efficient process for making changes to sponsor-driven eConsent documents when required by the local IRB or research institution ● Smooth reconsenting process and version management with access to a participant’s consent history ● Ability to manage clinical research associate (CRA)/monitor access ● Adequate technical support as needed ● Support for IRB submission ● Potential for integrations (IRB, clinical trial management system [CTMS]) ● Immediate access to executed consent records, metadata, and audit trails, with the ability to reconstruct the consent process during audits ● Supports ownership and oversight of the complete consent process and consent process documentation (patient comprehension, understanding, time to review, voluntary participation, etc.) |
| IRB | ● Must support an appropriate consent process
● System meets regulatory expectations for transparency, participant comprehension, and record integrity ● Adequate version control process ● Timely updates to consent content in the system when protocol amendments or consent form changes occur ● Appropriate patient identity verification process ● Supports the complete consent process |
| Senior Leadership | ● Clear cost-benefit ratio and ROI
● Central oversight for study enrollment progress and quality audits of consent process ● Audit/inspection risk reduction |
| System Owner/ Information Security/IT | ● Compliant with the ICH guideline for GCP and a validated system according to 21 CFR Part 11 of the Code of Federal Regulations in terms of meeting “fit-for-purpose” standards
● Meets security and data privacy standards ● Appropriate access control ● Validation process support |
| CRA/Monitor | ● Appropriate system access
● Access to all consent forms |
| Sponsor/CRO | ● Alignment with sponsor SOPs
● Allows for global alignment across sites ● Continuous access for sites to consent participants with the current consent form version ● Access to consent data for monitoring and audits ● Meets data privacy and security standards ● Reduces version deviations and supports faster time for reconsent completion ● Potential for integrations ● Compliant with the ICH guideline for GCP and validated under 21 CFR Part 11 as a system that meets “fit-for-purpose” standards ● Audit/inspection risk reduction |
| eConsent Vendor | ● High site and participant adoption
● Low support burden ● Successful integrations to reduce manual work |
Core Success Indicators for eConsent
Rather than suggesting complex KPIs, the working group recommends focusing on a small set of qualitative and directional measures, based on the success measures defined above. Since consent operations primarily occur at the site regardless of the deployment model, these metrics are site-centric but apply to both deployment models.
These indicators are designed to help sites, sponsors, and vendors assess the operational effectiveness of eConsent systems. The aim is to gather directional data to identify burden and track improvement over time, especially considering there is a learning curve for any new process, eventually creating benchmarks. Note that it may be important to differentiate some of these metrics by therapeutic area since different diseases, their stages, and patient populations may impact the usage of eConsent. This framework intentionally omits participant-facing metrics to focus on the site’s operational success indicators.
Adoption and Access
- % of consented participants using eConsent vs. paper
- % of studies offering eConsent as an option
- % of consents completed remotely vs. in-person
Workflow Impact and Operational Efficiency
- Site-reported time savings on administrative burden (e.g., paperwork, scanning, version tracking, duplicate documentation)
- Assess regularly since it may take time to realize any benefits as the system is adopted and familiarity grows
- Average onboarding/training time for staff
- Time needed for training on system updates
- Number of helpdesk tickets and IT escalations
- Time from IRB approval of a consent form to it being active in the eConsent system (Including time for site-specific updates and system changes that require sponsor action)
Data Quality and Compliance
- Number and type of consent deviations (vs. paper consent)
- Sponsor/monitor access delays or issues
- Audit/inspection access delays, issues, or findings
- IRB review/approval friction with eConsent forms or systems
- Ability to manage hybrid consenting using both paper and electronic forms
- Software usability for participants (complaints, failures, successes)
- Alignment with consent SOPs, ability to support consent process documentation
System Fragmentation
- Number of different eConsent platforms used at the site
- Integration with CTMS, IRB portals, or electronic investigator site file
- Staff-reported duplication of effort due to system fragmentation (Y/N or score)
Staff Satisfaction and Burden
- Overall ease of use rating for different site roles (PI, CRC, regulatory staff)
- Perceived impact on workload compared to paper (better/worse/same)
- Confidence in system compliance and audit readiness (Y/N or score)
Conclusion
As eConsent becomes more widely adopted, it’s critical that we measure not only how it supports participants but also how it impacts the operations of the research sites tasked with implementing it. This article outlines a site-centered definition of success that applies to all stakeholders and moves beyond patient-facing metrics to include workflow efficiency, data quality, compliance readiness, and system burden. Both site-owned and sponsor-deployed eConsent platforms can be assessed using the suggested qualitative and directional core success indicators.
This framework is just a starting point, and the authors encourage all stakeholders to incorporate additional metrics as appropriate. Once stakeholders have a baseline understanding of operational impact, they can move into more quantitative measures. Ultimately, defining and measuring what matters most to sites is key to improving adoption, reducing burden, and realizing the full promise of eConsent in clinical trials.
References
- Florence 2024 State of Tech-Enabled Clinical Trials Report. https://www.florencehc.com/downloads/2024-state-of-tech-enabled-clinical-trials-report/
- Florence 2025 State of Tech-Enabled Clinical Trials Report. https://www.florencehc.com/downloads/2025-soi/
- What Drives eConsent Adoption? Reasons May Be Different Than You Think. 2024. Clinical Leader. https://www.clinicalleader.com/doc/what-drives-econsent-adoption-reasons-may-be-different-than-you-think-0001
- The clinical trial technology landscape. 2025. https://researchrevolution.com/tech-vendor-map/
- Transcelerate eConsent Initiative. 2021. https://www.transceleratebiopharmainc.com/initiatives/econsent/
- European Forum for Good Clinical Practice eConsent Initiative. 2022–2025. https://efgcp.eu/project?initiative=eConsent
- FDA Guidance Document on Use of Electronic Informed Consent in Clinical Investigations—Questions and Answers. 2016.
- European Medicines Agency Guideline on computerized systems and electronic data in clinical trials. 2023. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systemselectronic-data-clinical-trials_en.pdf
- ICH Guideline for Good Clinical Practice E6(R3). 2025. https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf
- The New Era of Clinical Trials: Adopting Electronic Informed Consent. 2024. HIT Consultant. https://hitconsultant.net/2024/01/17/the-new-era-of-clinical-trials-adopting-electronic-informed-consent/
- Effective eConsent Strategies for Every Study: Utilizing the eConsent Fit-for-Purpose Study Framework. 2024. Applied Clinical Trials. https://www.appliedclinicaltrialsonline.com/view/effective-econsent-strategies-fit-for-purpose-study-framework
- Global eConsent in Healthcare Market Report 2023: Adoption of eConsent in Clinical Trials by Elderly Participants Anticipated to Rise Significantly. 2023. GlobeNewswire. https://www.globenewswire.com/news-release/2023/06/28/2695993/0/en/Global-eConsent-In-Healthcare-Market-Report-2023-Adoption-of-eConsent-in-Clinical-Trials-by-Elderly-Participants-Anticipated-to-Rise-Significantly.html
- eConsent in clinical trials: what’s new and what’s yet to come? 2023. Clinical Trials Arena. https://www.clinicaltrialsarena.com/news/econsent-in-clinical-trials-whats-new-and-whats-yet-to-come/
- Buckley MT, O’Shea MR, Kundu S, Lipitz-Snyderman A, Kuperman G, Shah S, Iasonos A, Houston C, Terzulli SL, Lengfellner JM, Sabbatini P. 2022. Digitalizing the clinical research informed consent process: Assessing the participant experience in comparison with traditional paper-based methods. JCO Oncology Practice 19:e355–64. https://doi.org/10.1200/OP.22.00425
- Cohen E, Byrom B, Becher A, Jörntén-Karlsson M, Mackenzie AK. 2023. Comparative Effectiveness of eConsent: Systematic Review. J Med Internet Res 25:e43883. doi:10.2196/43883. PMID:37656499; PMCID:PMC10504628.
- CISCRP 2019 Perceptions and Insights Study, Participation Experiences. https://www.ciscrp.org/wp-content/uploads/2019/12/Participation-Experiences-04DEC-1.pdf
- CISCRP 2023 Perceptions and Insights Study, Participation Experience. https://www.ciscrp.org/wp-content/uploads/2024/11/2023PI_Participation-Experiences.pdf
Author Affiliations
Amanda Zenere, Senior Customer Success Manager, Florence Healthcare
Amber N. Hood, DFS, MS, CPIA, CIP, Director, Regulatory Compliance and Research Facilities, Oklahoma State University Center for Health Sciences
Candida Barlow PhD, MSN, CRN-BC, RN, Director, Clinical Research, Oklahoma State University Center for Health Sciences
Catherine Gregor, MBA, CCRC, CCRP, Chief Clinical Trials Officer, Florence Healthcare
Istvan Fekete, Principal, Attain Partners
Kamila A. Novak, MSc, Principal, KAN Consulting MON. I.K.E.
Katherine Leibowitz, JD, Co-Founder and Managing Member, Leibowitz Law
Megan Solomon, LPN, Lead Coordinator, Regulatory and Compliance, Northwest Georgia Oncology Centers, P.C.
Spencer Phelps, Director, Office of Clinical Research, St. Joseph’s Health and St. Peter’s Health Partners
Andrea Bastek, PhD, Vice President, Market Strategy, Florence Healthcare
