Top 10 eConsent Solutions for Clinical Trials

Plus resources with free guidance for implementing eConsent

eConsent meaning: What is electronic informed consent in clinical trials?

Informed consent forms (ICF) are used in clinical trials to ensure participants are fully aware of all details of the trial, including its risks, and to formalize and record their willingness to participate in the research. This has traditionally been done on-paper and in-person, as two-way communication between the patient and the researcher is typically required to verify complete comprehension of the implications of a clinical trial.[1] During the COVID-19 pandemic, the consenting process was faced with a new obstacle, which resulted in the accelerated adoption of electronic consent (eConsent).

eConsent fulfills the same purpose as paper-based informed consent, but using electronic forms rather than paper ICFs. Thus, an eConsent form is an electronic system used to inform participants about the details of a clinical trial and obtain their consent to take part in the study. eConsent is critical for the transition of clinical trials to digital methods, leading to improvements in efficiency and data quality, and offers further benefits of increased comprehension and patient engagement.[²]

What are the benefits of eConsent in clinical trials?

During the consenting process, the patient has the right to ask any question regarding the research and is given appropriate time to think and discuss it with their friends, family, and healthcare providers. Electronic consent facilitates this process by making the information available remotely. Sponsors can also increase patient comprehension through engaging and informative graphics and videos, which can often convey information more effectively than long texts. For the sponsor, eConsent organizes all consent records into one location that is easily accessible and backed up safely. There are multiple other benefits of e-consent over its paper-based counterpart, for patients, sponsors, and CROs alike. Let’s take a look at some of them.

Benefits for patients

• Improved experience - According to CISCRP, around 14% of participants don’t complete clinical trials, and drop out was correlated with a lack of understanding of informed consent documents and feeling that their questions about the consenting process were not answered.[³] Thus, facilitating patients’ comprehension and engagement may directly improve patient experience and reduce discontinuation rates.[²]
• Increased flexibility and comfort - With eConsent forms, patients don’t have to worry about reading the consent form in one go and signing it. They can access the form from home, review it slowly or multiple times, and then make an informed decision. This also reduces time spent clarifying points that were mentioned in the consent form but perhaps not explained clearly. A smoother, less-stressed consenting process is less likely to turn patients off of joining the study.

Benefits for Sponsors and CROs

• Improved patient retention - As discussed above, a smooth consenting experience and improved comprehension and engagement decrease the likelihood of patient drop-out mid-trial. As dropouts negatively affect study power, patient retention is vital.

With the use of graphics and videos, sponsors can ensure that each patient fully grasps each section before moving on to the next. Follow-up questions can be added, and supplementary videos or other multimedia formats can be included to help participants with terms/concepts that are particularly hard to understand. Informed patients tend to be more satisfied with their trial experience, which directly impacts retention rates.[⁴]

• Enhanced data quality - eConsent forms collect data coherently by using field rules/validation rules and automatic edit checks and error flagging, reducing potential errors and eliminating the need for manual verification of data. This becomes especially relevant and helpful when patients input data themselves or when consenting would be done across multiple sites.
• Less paperwork - It has been suggested that switching to eConsent can save sponsors one hour of administrative work per patient enrolled. eConsent forms can easily be sent out via email or text message, and stored in the cloud for easy access and automatic backups.[³]
• Traceability - Electronic informed consent benefits CROs and sponsors running multiple clinical trials or working with multiple sites by enhancing document tracking. Sponsors can benefit from automatic versioning, coherence in data fields and between data entered from various sources, and improved audit trails and regulatory compliance..[⁴]
• Learning opportunities - another major advantage of eConsent forms is that they offer CROS and sponsors the opportunity to learn, adapt, and create a patient-centric consent process. By monitoring how long patients take to fill out the form and which areas they find harder to understand, sponsors can revisit and refine the content form to improve readability.[⁴] This enhanced consideration of patient experience aligns with the concept of patient centricity that is becoming increasingly important in clinical research.

eConsent form features and multimedia capabilities

Whereas traditional, paper-based ICFs are typically limited to text and printed graphics/illustrations, eConsent opens up possibilities for the inclusion of various multimedia formats to help convey the aim of the trial and what the protocol entails. Electronic informed consent systems and forms might include:

• Text, which can be adjusted for size and readily translated into different languages
• Video, with captions offered in various languages
• Audio clips, also in various languages
• Images, which can be expanded/zoomed-in
• Interactive graphics

Further, eConsent could include features to assist with remote consenting, such as electronic signature capabilities, and others designed to verify that the patient understood the content:

• Built-in dictionary/glossary, which could be set up to reveal the meaning of a term by hovering over or clicking on it in the text
• Comment boxes to write any doubts or ask for clarification
• Flags to mark specific content for review or clarification
• Summary boxes
• Knowledge review - short questionnaires to test the patient’s comprehension of the information presented, in each section or overall

One of the beautiful features of eConsent is that all of these capabilities and functions can be selectively combined and customized, allowing sponsors to use eConsent forms perfectly matched to the trial’s design and the needs of the patient population.

Considerations for the implementation of electronic consent forms

Now that the benefits of eConsent and its impacts on patient retention and data quality are clear, we will discuss some ways to go about implementing eConsent into your workflows. There are essentially two broad options – contract a pre-built and quickly customizable eConsent solution from a reputable vendor (such as those listed in the next section), or create eConsent forms manually.

eConsent may be one of the simplest of the numerous eClinical solutions available to create from scratch, as electronic informed consent forms could be as simple as PDFs with electronic signature capabilities. A sponsor could create informative videos, upload them to YouTube or a private server, and include clickable links to these videos in the PDF forms, which can simply be emailed to all participants. Nonetheless, there are many considerations sponsors should keep in mind if this is the route they choose, particularly relating to regulatory compliance. Partnering with an eConsent provider may accelerate the launch time and prevent you from having to navigate some of these considerations yourself, but in either case, the following sources of information can be helpful when adopting eConsent in your trial workflow, whether through a custom setup or a third-party solution.

FDA Implementation Guide

The FDA offers guidance on the use of electronic informed consent for IRBs, investigators, and sponsors. The guide was prepared by the collective efforts of the Department of Health and Human Services (HHS), the Office for Human Research Protections (OHRP), and the Food and Drug Administration (FDA). It provides background context and then specific guidance through a question-and-answer format, designed to help sponsors implement eConsent and electronic consent forms in a way that is sufficiently informative, protects patients’ rights, and optimizes the quality and integrity of the eConsent data in regard to regulatory requirements.

Some basic highlights from these guidelines regarding implementation and the presentation of information include[⁵]:

• Use clear, understandable language
• Inform patients about how long the process will take and what information will be presented and collected
• The system should be intuitive to navigate and allow the patient to go back and forth between sections
• Assistance should be provided throughout the process
• Patients should also be given the option of a paper-based consent form if needed or desired

The complete implementation guidance can be found here: Use of Electronic Informed Consent | FDA

Transcelerate Biopharma Implementation Guide

Transcelerate Biopharma offers free and detailed guidance for sponsors/sites to implement eConsent (and various other eClinical solutions), including some free tools. The aim of the initiatives is to help the industry advance by enhancing process efficiencies. Their eConsent implementation guidance is presented in a 4-step process:

• Pre-implementation - Understand the organization’s objectives and what it wishes to achieve. Divide the task into separate parts, such as planning, development, execution, etc., and allocate the necessary time and resources for each stage.
• Feasibility - Review successes and failures of eConsent in previous studies, and implement the eConsent system on a small scale first. Define the multimedia components to be included and consider user privacy and legal/data regulations.
• Design/readiness - The vendor and sponsor should communicate to create a contingency plan, an issue escalation plan, a main contact person, and to understand the regulatory landscape.
• Execution/closeout - Establish the process to be followed for consenting each participant and interacting with the eConsent system. Monitor interactions and operations, and ensure secure transmission of patient data to the data server.[⁶]

Have a look at Transcelerate’s eConsent Implementation Guidance here.

Top 10 eConsent form providers for clinical trials

As mentioned, it may often prove to be easier to contract a reputable provider of eConsent solutions. When there is a particular rush to get the study off the ground, these pre-fabricated solutions can usually be customized rapidly for quick progress to enrollment. This option may also prove to be attractive for sponsors wishing to avoid navigating regulatory landscapes when creating a custom eConsent solution. However, it’s important to partner with a provider that offers the functionality and support needed for your trial or organization. Thus, we have curated the following list of the top 10 e-consent solutions for clinical trials based on their market share and reliability. The solutions are not listed in any particular order/preference.

When choosing an eConsent vendor or solution, there are a few features to look for and/or questions to ask to ensure you are getting the best option for your organization. Examples include:

• Integration capability with other software, such as eTMF, CTMS
• Built-in data validity checks
• Built-in accessibility features for participants with various disabilities
• How easy is it to customize the eConsent forms?
• Does the provider offer pre-made forms, explanatory text/videos, or a library of pre-made content?
• What is the product’s/vendor’s record of success in prior trials? Is it compliant with 21 CFR Part 11 and HIPAA in the U.S., or the relevant international regulations, such as GDPR?[³]

Medidata eConsent

Medidata eConsent is an electronic informed consent form solution that is user-friendly and allows patients to be directly onboarded into Rave EDC, Medidata’s electronic data capture platform. It offers easy integration with other software and allows patients to enroll on-site or remotely. Moreover, the system is flexible and customizable with easy configuration tools, eliminating the need for a developer, HTML conversion, or other administrative tasks that increase set-up timelines.

May be ideal for: Sponsors/CROs looking for a customizable eConsent solution that is easy to use and integrated with other trial and data management systems for improved data accuracy and simplified, streamlined workflows.

ClinConsent

ClinConsent is an electronic informed consent form tool that can be used as a stand-alone solution or integrated with any EDC or EHR platform. It reduces paperwork by allowing patients to consent and re-consent remotely. It is simple and user-friendly and can be used on multiple devices. It offers multiple features like quiz modules and FAQ documents to reduce communication time and ensure the patient completely comprehends the study before signing.

May be ideal for: Sponsors and CROs looking for an easy-to-use and pre-made yet customizable eConsent tool that can be readily integrated with EDC software and EHR.

Advarra eConsent

Advarra eConsent is a great eConsent tool that reduces audit risk by maintaining compliance with HIPAA and CFR Part 11. It is a mobile-friendly system that optimizes the patient enrollment and onboarding process by guiding patients step-by-step, and standardizing regulatory and personal forms. It also sends real-time alerts to remind patients about re-consenting. A stand-out feature is its automated knowledge assessments that track progress, provide hints for missed questions, and provide analytics.

May be ideal for: Organizations looking for a pre-made eConsent tool that is user-friendly, patient-centric, and has an intuitive dashboard for easy monitoring and tracking.

Veeva eConsent

Veeva eConsent is an end-to-end eConsent form that seamlessly connects sponsors, patients, and sites under one platform for the entire eConsenting process. It reduces administrative burden and training requirements by eliminating manual processes and the need to integrate with additional systems and applications. Veeva eConsent allows users to access the system on their mobile devices through the MyVeeva for Patients app, and guides patients throughout the process and ensures all sections are reviewed before sign-off.

The editor tools enable sponsors to create, share, review, and approve eConsent forms and automate versioning for accurate data compliance and traceability.

May be ideal for: Sponsors and CROs looking for a simple and effective eConsent tool that is user-friendly, reduces paper and administrative work, and cuts down on trial execution time through quick creation, approval, review, and tracking of eConsent forms.

Signant SmartSignals eConsent

Signant SmartSignals eConsent can be used by organizations of any size or scale. It ensures sponsors and CROs use the latest ICF version and eliminates audit findings and ambiguities by offering time- and date-stamped processes. The system can be integrated with Signant’s own eCOA, RTSM, and Patient Concierge solutions. Moreover, the intuitive dashboard is easy to manage and offers a real-time picture of the study progress.

They offer 3 packages, catering to different needs and trial complexities:

• Silver - PDF-based eConsent forms that are simple and cost-effective
• Gold - PDF-based eConsent forms with additional features like a monitoring dashboard, patient portal, version control, and on-site or remote signature options
• Platinum - digital eConsent forms for complex studies, including video support, template libraries, and integration with other solutions

May be ideal for: Organizations looking for eConsent solutions that can scale up as they grow and offer an optimized patient understanding and experience through its user-friendly and intuitive portal.

DrugDev eConsent

DrugDev eConsent is a feature-filled eConsent tool with an emphasis on improving patient experience. It uses video content to ensure the patient understands trial-specific information and how to use the system to provide their consent. It is ideal for patients with various disabilities as it uses a combination of graphics, animations, and audio to inform patients. Other novel accessibility features include font scaling and narration. It also includes linked terms that produce a pop-up explanation of difficult concepts and words. Patients progress through the eConsenting process by marking either “I understand” or “ask a question” after each section.

May be ideal for: Sponsors and CROs looking for a flexible eConsent system that is particularly user-friendly for patients and caters to those that require enhanced accessibility features.

Castor eConsent

Castor eConsent is an all-in-one eConsent solution that enables organizations to capture data efficiently and provides analytics on trial progress. It can be used as a stand-alone solution or integrated with the Castor product suite (including EDC and ePRO) to capture data accurately in a single ecosystem. It is 21 CFR Part 11-compliant and offers enhanced security through multi-factor authentication and audit trails. Patients can benefit from video visits for remote eConsenting and enroll themselves through the patient portal.

May be ideal for: Sponsors and CROs looking for a fully-functional eConsent platform that can take care of all administrative tasks, from recruiting to screening, and offers enhanced security measures and simple integration with other solutions.

Florence eConsent

Florence eConsent allows sponsors and sites to make the transition from paper-based consent forms to electronic consent forms easily with its intuitive, easy-to-use interface. It is a mobile-friendly software that enables patients to log in and continue the consenting process from anywhere. It helps sponsors and CROs manage workflows by enabling them to invite, assign, and manage study staff with predefined permissions. Moreover, with the Florence eBinders platform, sponsors can use an integrated single sign-on platform to manage the study easily and stay compliant.

May be ideal for: Sponsors and CROs looking for intuitive eConsent tools that can easily manage large-scale studies and multiple workflows while remaining compliant with global regulations.

Medrio eConsent

Medrio eConsent helps trial sponsors create a patient-centric eConsent process by leveraging educational techniques and multimedia to illustrate what participation implies and increase patient retention. Video content, images, audio, and FAQ documents can be added to help patients understand the clinical trial, its protocol and procedures, and its risks and benefits. It is extremely flexible and adaptable to various workflows. ICF version tracking reduces audit findings and facilitates sharing of ICFs and revisions as well as the reconsenting process.

May be ideal for: Sponsors and CROs looking for a patient-centric eConsent system that offers various multimedia options for easy understanding, alongside a high degree of flexibility.

Medable eConsent

Medable eConsent helps sponsors and CROs expand clinical trials globally by offering an easy-to-manage system that can be integrated with other systems without the need for professional assistance. It features a self-service authoring tool where sponsors and CROs can easily create eConsent templates, and these can be delivered remotely via TeleVisit, offering flexibility to patients. Patients can sign remotely or on-site, through a web-based app where they have access to interactive diagrams, explainer videos, and self-assessments for easy understanding. It also features permission-based workflows based on designated roles and responsibilities within the team, and BioSample attribution

May be ideal for: Organizations looking for a flexible eConsent tool that is globally compliant, highly scalable, and accessible from any device that is connected to the internet.

Conclusion

eConsent is one pillar of the increasingly digitized modern clinical trial. A well-matched eConsent solution can help you streamline the recruitment and consenting process, increase patient engagement and comprehension of the protocol through interactive multimedia content and increased flexibility, and stay organized and compliant.

When choosing an eConsent tool, ensure it meets your trial’s complexity and needs, can be integrated with other software for data accuracy, and is flexible and customizable (or comes pre-configured with all the features you need by default). Those requiring a higher degree of configurability or specific functions might also consider taking advantage of the great free resources to create their own eConsent forms that integrate readily with their existing workflow and are internally managed for even greater control.