Transforming clinical trials with electronic consent: benefits and best practices

If you’re running a clinical trial, you know just how crucial it is to get informed consent from participants. But juggling piles of paper forms can be a real headache – not to mention a compliance risk if any go missing. That’s where electronic consent forms come in. By digitising the process, you can make your trial far more accessible, just as compliant, and extra secure.

Make it easier for participants

Finding (and retaining) willing participants is already an uphill battle for clinical trials. Electronic consent forms remove a lot of the barriers that put people off, by allowing people to review materials and provide consent from anywhere, whether they’re home or on a mobile device.

This means no more worrying about scheduling in-person appointments just to get signatures; no more missed appointments or inconvenient trips to try and get to you. Participants can complete everything on their own time when the details are still fresh in their mind.

Comprehensive audit trails keep you compliant

The MHRA and ethics committees require detailed documentation of the entire consent process to make sure proper protocols were followed. Electronic forms make this a breeze by automatically capturing a full audit trail – when the participant received materials, when they viewed them, when they completed consent steps, etc.

So you’ll have ironclad records showing you followed protocol to the letter. And manually flipping through reams of paperwork will be just a distant memory!

“Researchers must show that their research takes account of the views of patients and ordinary members of the public. They must also show how they protect the privacy of the people who take part. An NHS research ethics committee checks this before the research starts.” – NHS Health Research Authority

Encryption protects sensitive data

Participant privacy is the most important consideration in clinical research, and when dealing with any personal health data. Electronic consent forms use powerful encryption to protect any and all sensitive information during transmission and storage. So you can be confident it’s secure and only authorised people can access it all.  And centralised, access-controlled management makes it easy to apply the same consistent security policies across all your trials.

Inaccessible, cumbersome, and risky paper-based consent processes are quickly becoming a thing of the past. By digitising with a secure, validated electronic form system, you’ll be able to streamline participant recruitment while still meeting the highest standards for compliance and data protection. A cure for clinical trial headaches if we ever heard one!

Want to talk more about incorporating electronic consent forms into your process? Drop us a message and let’s talk! 

The Author

Jonny Vaughan

Founder & Technical Director of 10 Degrees. Jonny's day to day focus is on determining the best technical solutions for our clients, driving technical innovation and leading our sustainability agenda.

The 10 Degrees Team