Developing and Implementing eConsent in Clinical Trials


For many years, clinical trial stakeholders have debated over the need to incorporate electronic consent to facilitate the participants and streamline the process of data capturing. However, it wasn’t until 2020 when a vast majority of clinical research sites were forced to shut down amid global lockdown, and e-consent emerged as the hope for the continuation of clinical studies.

Now, as the world has left the days of the pandemic behind, e-consent remains relevant for the adoption of a modernized clinical trial approach. Many research sites, trial sponsors, and participants now vouch for the benefits offered by electronic consent and the need for it to become a permanent part of decentralized clinical trials.

However, the development and implementation of e-consent is a challenging task across the board. And until those challenges are adequately dealt with, the clinical research industry cannot fully leverage the benefits of the model.

Four Tips to Develop and Implement E-Consent

For those clinical trial sponsors who’re conducting decentralized clinical research and seek to incorporate electronic consent, here is the way to go about it.

Fully Understand Your Participants

Clinical research organizers must be willing to understand their participants and cater to their needs. This means that rather than just extending EDC systems, facilitating through telehealth, webinar, and virtual conferences should become a part of the clinical trial process. This will allow participants to learn and adopt the technology at a similar pace as the industry.


Upskill the Researchers

According to a 2020 survey, only 3 percent of clinical researchers were experienced with using e-consent software. Another 28 percent reported being novices, whereas a vast majority remained unequipped to fully leverage the model. The first task for clinical trial sponsors and research sites is to upskill the researchers to be able to use e-consent technology.

Pick the Right E-Consent Software

Another major challenge is picking the right electronic data capture and e-consent software. By doing so, many errors, delays, and learning curves can be avoided that may otherwise hinder the adoption of e-consent technology.

Don’t Overlook Compliance Issues

Electronic data capture for a clinical trial cannot undermine the importance of compliance. Sponsors and researchers must bear in mind the regulatory guidelines established by FDA, HIPAA, and IRB. It’s essential that compliance guidelines are met when using e-consent tools.

Integrate Trials with EDC Systems Now!

If you wish to use e-consent in your clinical trial data management, then contact Clinical Pursuit. The EDC software for clinical trials has built-in e-consent software, remote monitoring features, and a comprehensive range of clinical data management solutions.

Book a demo of the software now.



 

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