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 clear, practical framework that defines the value of integrating eConsent systems with key eClinical technologies. In the companion piece to this article, “Envisioning eConsent Success (Part I): Measuring Operational Impacts at Clinical Trial Sites,” the group defined the different deployment models for eConsent and outlined key stakeholder success measures for using these systems. This article 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
The decision to purchase eConsent software often depends on the number of studies that will utilize the platform. Implementing the platform system-wide, across many studies, helps organizations justify the cost of the system and implementation as well as of the disruption that comes from implementing a new tool and process. On the other hand, buying and/or implementing a system for a single study can be more expensive than planned when considering the cost of disruption. As noted in Part I, these challenges have blunted eConsent adoption and implementation and resulted in fragmented usage of the many vendors across studies in the industry. This fragmentation makes it challenging to integrate eConsent with other eClinical systems and creates duplication, delays, and confusion, particularly at the site level.
As defined in Part I, the users of eConsent systems are always site staff and participants, but there are two different models for purchasing and deploying the system: site-owned and sponsor-deployed. Each deployment model has its own economic factors to consider.
Deployment Model Implications
The investment required by sponsors to implement eConsent, including system validation, staff training, process modification, change management, and ongoing support, may be justified when it can be leveraged across multiple studies, where it is most likely to deliver a return on investment (ROI) from labor savings, quality improvement, or timeline acceleration.
Conversely, sites with larger or sustained research portfolios may derive greater long-term value from a site-owned platform, particularly where standardization across studies and sponsors can be achieved. Similar considerations apply to sponsors; accordingly, the economic rationale for either model is primarily determined by anticipated study volume and the ability to leverage implementation and change management costs across future use. There is no “one-size fits all” approach for how to consider all of these factors.
Beyond ROI, the overall operational impacts 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 (see Table 1 in Part I).
Key Integration Objectives
The goal of integration is to ensure that eConsent data and documents can flow securely and automatically between systems to improve efficiency and reduce staff burden and quality errors. Potential benefits of system integrations include:
- Eliminating duplicate data entry and manual document uploads
- Using consent data as a gate/trigger for other systems, such as electronic patient-reported outcomes (ePROs) or interactive response technology (IRT)
- Reducing compliance risk via audit-ready consent documentation and version control
- Enabling real-time oversight for site leaders, monitors, and sponsors
While the core integration goals of eConsent platforms are consistent among users, the strategy for achieving interoperability differs significantly depending on whether the eConsent system is owned by the site or deployed by the sponsor.
Sponsor-deployed systems typically operate as stand-alone platforms with minimal integrations to site systems, which is understandable given that they are deployed by an external entity for a single study. Sponsor-deployed systems cause fragmentation for sites because different sponsors provide different platforms and sites have their own consent processes for situations when an eConsent tool is not provided by a sponsor.
Lack of interoperability with site systems creates duplicate effort (ex: manually tracking consents on a paper or digital log in the investigator site file [ISF] and/or in the clinical trial management system [CTMS]). These systems also require a new process for sites to maintain audit-ready documentation since they do not own the system. Sites are responsible for the consent process and documentation to ensure regulatory compliance, so this fragmentation can be particularly disruptive.
Site-owned systems certainly avoid some of these problems, and allow for reusable integrations, but require upfront system investment and additional investment for integrations. This can be a challenge for small sites and sites with a low number of studies.
Since both site-owned and sponsor-deployed models will likely co-exist in the industry for some time, this working group included considerations and limitations of both models in this framework. In both models, the ROI should be estimated for any proposed integration. Increased site staff efficiency and reduced compliance risk will likely be the value drivers of an eConsent integration, and can have a significant impact over time.
Core Systems for Integration
To support efficient trial operations, consent data and documents can integrate with the broader clinical trial technology stack to reduce duplicate data entry and manual document downloads/uploads, and to ensure consistency and compliance. Tables 1 and 2 outline the key systems that could connect with eConsent platforms and the purpose of each integration. The scope of integrations will vary between site-owned and sponsor-deployed eConsent systems.
Table 1: Site-Owned Integrations
| System | Integration Purpose |
| Electronic Health Record (EHR) | Retrieve participant identity and demographics needed to enter a participant in the eConsent system; Record consent visit data; Store the final signed consent form (depending on site standard operating procedures) ——————————————————————————— |
| eISF/eRegulatory | Maintain master institutional review board (IRB)-approved consent version; Manage version expiration dates; Populate consent logs with participant ID, consent version, and date of consent ——————————————————————————— |
| Participant Source Binders | Store final signed participant consents; Provide access during subject or monitoring visits ——————————————————————————— |
| CTMS (Site-Owned) | Track participant consent status, version, and date; Track sub-study consents; Track withdrawals; Manage reconsent requirements; Link to enrollment and visit workflows; Enable consent-dependent actions ——————————————————————————— |
| Payment Systems (Site-Owned) | Trigger site and participant payments based on successful consent completion ——————————————————————————— |
| Training/Learning Management Systems | Gate access to eConsent platforms until site staff complete protocol or system-specific training and are delegated appropriately ——————————————————————————— |
| IRB Portal (Local) | Retrieve approved consent versions; Deactivate old versions when new version is approved to prevent version errors; Track expiration dates ——————————————————————————— |
| Other Participant-Facing Workflows | Include W9s, release of records forms, future use consent forms, or post-trial communication preferences in the same system to streamline workflows for site staff and participants ——————————————————————————— |
Table 2: Sponsor-Deployed Integrations
| System | Integration Purpose |
| Electronic Trial Master File (eTMF) | Centralize storage of all master consent versions (including country/site-specific); Store central IRB approval records; Store site-specific IRB/sponsor-approved consent versions (including country/site-specific) ———————————————————————————- |
| CTMS (Sponsor-Owned) | Track consent version and dates for participants; Monitor compliance with version requirements; Track sub-study consents; Track withdrawals; Enable oversight and tracking ———————————————————————————- |
| Electronic Data Capture (EDC) | Enter consent date and version automatically before unlocking further data entry ———————————————————————————- |
| IRT/Randomization and Trial Supply Management (RTSM) | Block or allow randomization and investigational product shipping based on verified consent status/version and date
———————————————————————————- |
| ePRO/Electronic Clinical Outcome Assessment (eCOA) | Validate participant consent before enabling access; Track consent version/date for sub-studies or secondary endpoints
———————————————————————————- |
| Payment Systems (Sponsor-Owned) | Trigger site and participant payments based on successful consent completion ———————————————————————————- |
| Training/Learning Management Systems | Gate access to eConsent platforms until site staff complete protocol or system-specific training and are appropriately delegated ———————————————————————————- |
| IRB Portal (Central) | Retrieve approved consent versions; Deactivate old versions when new version is approved to prevent version errors; Track expiration dates ———————————————————————————- |
| Data and Safety Monitoring Board (DSMB)/ Adjudication/Imaging | Send consent version and date for safety adjudication or imaging workflows; Track sub-study consents to ensure correct imaging workflows are completed
———————————————————————————- |
| Central Lab, BioSample, and Imaging Systems | Send consent data to facilitate sample/CT/X-ray/MRI/Fluoro collection; Support eligibility checks when applicable and streamline data/file transmission; Include withdrawal tracking if applicable ———————————————————————————- |
Recommended Core Data Elements
To ensure eConsent platforms function as part of a connected clinical trial ecosystem, system connections must be built on reliable, standards-based integration methods. Whether site-owned or sponsor-deployed, eConsent systems should, at a minimum, offer the fields listed in Table 3 as required discrete data elements.
Table 3: Required Discrete Data Elements
| Data Field | Purpose |
| Participant ID | Unique participant linkage across systems |
| Consent Version | Audit-ready version tracking; Facilitate re-consent workflows |
| Date of Consent | Enrollment tracking; Integrated system workflow trigger/eligibility gating |
| Investigator Signature Date | Verification and compliance |
| Consent Method (e.g., remote/in-person) | Operational tracking |
| Consent Status | Enrollment tracking; Reconsent workflow trigger |
| Health Insurance Portability and Accountability Act (HIPAA) Authorization Date | Verification and compliance, where applicable |
| Participant Copy Provided (Y/N) | Regulatory requirement |
| Date of Withdrawal of Consent | Tracking early exits from participation |
| Sub-Study Consent (Y/N) | Enrollment tracking; Integrated system workflow trigger |
| Post-Trial Access (Y/N) | Gates post-trial communications |
| Future Research Consent (Y/N) | Gates future contact workflows |
While this list is not exhaustive of the desired data for an eConsent system to collect or transfer via an integration, it provides a foundation for common datapoints that all systems should include. The European Forum for Good Clinical Practice eConsent Initiative has included similar datapoints in their Glossary of eConsent terms Operational Aspects, describing key aspects related to operational management.{1} It is important to note these suggested data fields and operational aspects of eConsent are often also applicable in the traditional paper consent process. Since the consent process will often be hybrid, using both paper and eConsent, it is critical to consider how these datapoints will be captured and recorded for paper consents, and how that data can be incorporated in the system integrations to avoid having two completely separate processes.
Integration Challenges and Considerations
eConsent integration challenges vary depending on whether the system is site-owned or sponsor-deployed. Sponsor-deployed systems introduce more variability across studies, but integrations with other study systems can reduce the workflow transitions, logins, and data entry points for the sites working on those studies. Since that is a downstream impact, and because there is so much variability in sponsor/CRO technology stacks from study-to-study, the ROI of building integrations can be hard to justify.
Site-owned systems offer consistency across studies at the site but require significant initial investment for licensing, implementation, and integrations. These upfront costs can be difficult for sites to manage due to resource constraints. Many site systems are not built with open application programming interfaces (APIs) and sites often do not have the technical capacity to support integration efforts. The resource and technical constraints at sites can make it hard to justify system integrations despite the long-term efficiency gains.
Conclusion
eConsent is a tool that can eliminate a significant amount of paper and drive efficiency in the clinical trial industry. However, the efficiency and benefits of an eConsent system are limited by the technology ecosystem where it is deployed. Without seamless integration into other systems that support clinical trials, eConsent becomes another siloed tool that adds new friction. Key challenges to widespread integration are varying adoption and deployment models, hybrid workflows and lack of resources for integration efforts.
This integration blueprint outlines a practical, system-agnostic approach to eConsent interoperability that works across both site-owned and sponsor-deployed models. If sites and sponsors can focus on logical system connections for their deployment model, stakeholders can begin to reduce redundancy, improve data flow, and enhance oversight. If vendors can focus on using standard data elements and building open, well-documented APIs and flexible integration endpoints, the burden of integration will decrease. By measuring gains in efficiency, the value of these integrations can be proven over time.
With industry collaboration, we can move toward a future where eConsent systems are not standalone platforms, but connected, compliant, and supportive of both participant, site, and sponsor needs.
Reference
- The European Forum for Good Clinical Practice eConsent Initiative Glossary of eConsent. 2024. https://efgcp.eu/public/EFGCP%20Glossary%20of%20eConsent%20Terms.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
