In some of our other articles, we have already highlighted the many benefits of switching to the digital version of informed consent. Many companies and CROs are already making the shift, and some of them realize that there can be some challenges to eConsent implementation. This happens, most of the time, when researchers approach eConsent with the same mindset they used to work with traditional consent forms.
In this article, we share three tips for implementing eConsent successfully at the first try. The first step is to acknowledge that eConsent is different from paper-based consent in many ways, even though they serve the same purpose. Then, with some guidance, careful planning and rigorous self-assessment, your company will soon benefit fully from eConsent.
What is eConsent?
eConsent is the term to name different kinds of digital solutions that can be used to design, implement, and monitor the whole process of consent acquisition to participate in a clinical trial. It includes not only the digital form with the patient’s signature, but also information documents that can be shared online and online communication platforms between medical researchers and participants.
In some of our other articles, we have already highlighted the many benefits of switching to the digital version of informed consent. Many companies and CROs are already making the shift, and some of them realize that there can be some challenges to eConsent implementation. This happens, most of the time, when researchers approach eConsent with the same mindset they used to work with traditional consent forms.
In this article, we share three tips for implementing eConsent successfully at the first try. The first step is to acknowledge that eConsent is different from paper-based consent in many ways, even though they serve the same purpose. Then, with some guidance, careful planning and rigorous self-assessment, your company will soon benefit fully from eConsent.
What is eConsent?
eConsent is the term to name different kinds of digital solutions that can be used to design, implement, and monitor the whole process of consent acquisition to participate in a clinical trial. It includes not only the digital form with the patient’s signature, but also information documents that can be shared online and online communication platforms between medical researchers and participants.

#1 Partnering with an Experienced CRO
If your company is about to implement eConsent for the first time, one of the best advice we can give is to count on expert guidance. Full-service eConsent implementation includes partnering with an experienced CRO to have the whole consent process managed by experts.
This advice is useful not only for first timers, but also for companies who may have found resources acquisition to be too burdensome and decided not to conduct the eConsent process in-house. Moreover, choosing the right consent solution for your company might be a challenge that CRO professionals can help to overcome.
It is important, though, to choose carefully the contract research organization to partner with. Reputation and years of experience are important, of course, but are not the only points to consider. Specially in the case of eConsent management, it is advisable to check if the CRO in question has conducted clinical trials in the therapeutic area you are working in, because this ensures that they have dealt with consent process with similar groups of patients.
#2 Be Mindful of Timelines
This is good advice for any part of a clinical trial, of course. But as we are focusing on eConsent implementation, we might as well highlight how good time management can make all the difference, especially for those who still struggle to abandon the traditional consent process mindset.
It is a given that implementing eConsent will save you time, as many tasks can be automated, and template forms can be reutilized. However, this does not mean that you can reduce, immediately, the time allowed to complete the trial.
In fact, to have a successful first try, it is advised that you allow enough time for staff and all stakeholders to get used to the tools and maybe even get training in how to use them. The time spent getting acquainted with the eConsent software will be more than compensated for after, and this preparation avoids unexpected trouble with deadlines due to lack of experience.
#3 Do not Underestimate the Importance of Self-Assessment
This advice is to ensure that your first-time success lasts. The fact that something worked well in one clinical trial does not mean it will work in all others, but keeping track of each case’s experience is important to build your company’s record of success (and failures, so you know what to avoid).
For example, if you faced challenges in engaging researchers the first time that they are dealing with eConsent implementation (in the case you are not partnering with a CRO), maybe next time you can provide them with a short training before the trial starts. Through self-assessment, you can evaluate all stages of the implementation process after it is done, from an observer’s point of view.
This should be a standardized, institutionalized process, and not just an informal reflection. You can even schedule a date and time for this and have a template document to record the evaluation of each case, that can then be filed for future reference.
Summary
- eConsent is the term to name different kinds of digital solutions that can be used to design, implement, and monitor the whole process of consent acquisition
- Full-service eConsent implementation includes partnering with an experienced CRO to have the whole consent process managed by experts
- Good time management can make all the difference, especially for those who still struggle to abandon the traditional consent process mindset.
- Through self-assessment, you can evaluate all stages of the implementation process after it is done, from an observer’s point of view. This should be a standardized, institutionalized process
