If you’ve been around the clinical research industry, the concept of obtaining electronic consent (eConsent) is probably familiar to you. Considering the current pandemic we are in, many sponsors, sites, and CROs are slowly shifting towards an eConsent process in their clinical trial process. 

Why is eConsent important?

This preference is directly proportional to the innumerable benefits that eConsent can deliver in one’s clinical trials. It also enables better patient engagement and recruitment since both the parties (clinical trial) can make informed decision making. 

In this blog, we have listed 15 features most preferred features for procuring eConsent solution to be used in clinical trials:

List of features which highest preference and enquiry:

1. Is your eConsent user-friendly?

A user friendly eConsent form provides a seamless experience for the participants. Filling out the form is not only informative but becomes enjoyable. Aids like callout and comment boxes provide clarity and enhanced user engagement.

2. Does your eConsent ensures an absolute authentication features?

A secure eConsent solution is one that provides multiple layers of authentication, whether it be in the form of an OTP or an email verification. 

A secure solution also provides various methods of document authentication by requiring participants to upload multiple forms of identification such as a state ID, driver’s license, and/or a health card.

3. Choose eConsent with good query handling feature

A robust eConsent solution allows participants to enter their questions directly into the form where these questions are then routed to the appropriate internal query handling team. 

Responses from the query handling team are then automatically sent to the participant in the form of customized notifications allowing the participant to view responses at their own convenience.

4. Does your eConsent enables multi-language?

The multi-language feature is helpful when the study that is run has a population that spans across multiple countries. In such cases, a multi-language eConsent accommodates multiple languages for participants to easily comprehend what’s being conveyed in the eConsent form.

5.  eConsent should enable lag time configuration

Configuring lag time allows participants to take their time in understanding the study. You may want to set up a longer lag time for more complicated studies where average comprehension may take longer than a simpler study.

6. How easily accessible is your eConsent?

An eConsent solution that caters to a wide range of population is one that is considered to increase enrollment numbers and retention. 

It’s important to consider a solution that is accessible to the visually impaired, blind, and low literacy study participants. Features such as text to speech and font enhancements are examples of an accessible solution.

7. eConsent should have knowledge review feature

It’s crucial to ensure that all participants understand the benefits and risks of the study during the informed consent process. A knowledge review in the form of a short quiz enhances understanding and comprehension of the participants.

8. It should help in maintaining workflows

The ability to setup workflows for internal teams to handle queries, mimic organizational approval processes, and more are essential features. This enables users to streamline and digitize their informed consent process and gain a real-time visibility.

9. Does it support multimedia?

eConsent should enable setting up diagrams, charts, tutorials, and videos throughout the eConsent increases participant comprehension. 

Sometimes, just bare words can be boring and repetitive whereas enriched multimedia content can increase information retention whilst providing diversity in how the information is conveyed.

10. What is the storage mechanism in eConsent?

The ability to store the fully signed eConsent against the participant’s profile in a centralized system becomes key when you have a high-volume study. Once stored against the participant and the study, the fully signed eConsent becomes easily accessible and securely stored.

11. eConsent should enable multi-configuration

The ability to set up multiple eConsent forms for different types of studies is an important feature to have. Not every study will have the same type of content. The ability to use pre-built templates to easily set up forms for various types of studies saves tons of time and manual effort.

12. Does it allow document uploads?

This feature allows participants and internal teams to upload important documents that are pertaining to the participant and the related study. Additional identification, study-related and/or marketing brochures can be shared during the eConsent process. These shared documents, then, can be stored against the participant’s profile in the internal system. 

13. eConsent should have a dictionary/glossary feature

A dictionary or glossary that contains study and medical prevalent terms is sure to increase participant understanding and comprehension. If participants don’t understand a particular term in a section, they can visit the dictionary to clarify. 

14. Does it allow an electronic signature?

This feature allows the solution to truly be 100% electronic. There is no need to download a hard copy of the consent form to obtain a signature. All parties can digitally sign including guardians in the case of minors.

15. eConsent should facilitate reporting

It’s important to understand your participant’s general behavior around the eConsent forms. By understanding the average time spent on each section or why a particular video is not being fully viewed, you can begin to modify your consent forms to increase comprehension and better cater to your participants. 

Reports can be utilized to understand these trends and to transform your processes into a participant-centric one.

What are the benefits of eConsent?

Transforming your paper-based informed consent process into a 100% electronic one is proving to be a ‘must-have’ rather than a ‘nice-to-have’, especially considering today’s times. eConsent benefits clinical trials in multiple ways however small challenges still remains. 

Before finalizing on the eConsent solution that fits your needs, it’s important to understand how organizations are finding this transformation fruitful. 

Here are some of the ways pharma/biotech companies, CROs, and sites are benefiting from an eConsent solution:

Common eConsent Challenges solved with eConsent.

With organizations adopting new digital eConsent processes, such frequent challenges are becoming obsolete in clinical trials.

1. eConsent are racing through the ICF

With a solution that times each participant during each section allows for visibility into the consent process. Trends across participants and studies can be analyzed through reports that give valuable insight on participants’ behavior around the consent. 

Sections that may be too wordy or too vague can be modified to increase comprehension. Sections that have a low average time spent can be analyzed and modified accordingly.

2. Solution to the participant questions

A solution with query handling capabilities can easily take questions from participants and automatically route them to the appropriate internal user by setting up workflows. The responses to the questions can, then, be routed back to the participant through an email or SMS push notification.

3. Minimized fraudulent activity 

A secure and robust solution that comes with the ability to use multiple layers of authentication will provide maximum security and authentication. Requesting multiple forms of identification can be made mandatory and set up according to the regulatory requirements for that study and country. 

Final words

Transforming your manual paper-based ICF process into a truly 100% electronic one may seem daunting at first. So, fully evaluate your needs and do your due diligence before selecting the right eConsent solution for your clinical trial.

References:

• https://forteresearch.com/news/benefits-and-drawbacks-to-econsent/#:~:text=Although%20eConsent%20helps%20research%20staff,verifying%20identification%20and%20ensuring%20comprehension.
• https://www.pchalliance.org/news/new-continua-design-guidelines-enable-integration-patient-generated-data-electronic-health

• http://www.transceleratebiopharmainc.com/wp-content/uploads/2017/11/eConsent-Implementation-Guidance.pdf#page=7