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What is eConsent?

eConsent is a digital consent process that potential study participants must complete before enrolling in a clinical trial. With eConsent, participants can read and sign important consent documents online.

Some information that participants are given before providing eConsent include:

  • Explanation of the purpose of the research
  • An expected timeline
  • All procedures to be completed during the clinical trial
  • Any predictable risks or discomforts
  • Any possible benefits

Research teams looking into eConsent software must gauge how participant-friendly it is, if it matches their site’s workflows, and if it complies with FDA 21 CFR Part 11 and HIPAA.

Why is eConsent important for healthcare?

In clinical trials, getting consent from participants is vital for confirming they were told and understand essential information. eConsent takes this a step further by allowing research teams to collect this information from participants remotely.

eConsent improves the patient trial experience by ensuring the patients understand what to expect during the trial. Not only does this increase the odds of patients having a better clinical trial experience, but it also reduces the number of people who drop out of the clinical trial. Since a high loss-to-follow-up rate can threaten how valid the results of a clinical trial are perceived, the ability to keep more people in the trial is an important benefit of eConsent.