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Just as remote treatment options are increasing due to advancing technology and the COVID-19 pandemic, remote clinical investigations are increasing as well. Decentralized clinical investigations, especially those that involve medical device clinical investigations, will typically require some type of eConsent from the participants in the study.
This blog includes several best practices you should follow regarding eConsent in medical device clinical investigations. You can also watch our webinar on eConsent on demand.
eConsent involves two distinct types of consent.
Note that it's not always necessary to obtain both types of consent. Sometimes, there is a soft enrollment in studies. Sometimes, investigators may split the studies into two parts, each requiring a different kind of consent.
The consent process still requires several steps. These include presenting the objects of the trial or study, making sure participants understand all rights, risks, and ethics regarding the trial, and then gaining the participants' acceptance. Basically, eConsent is a digital reproduction of this process. You can complete eConsent digitally or traditionally. A traditional method means a signature on a piece of paper.
The individuals involved in this process include:
Electronic signatures are electronic using an ink-like signature on a specific device. A biometric signature may rely on fingerprints, iris scans, or even different types of algorithms. Digital signatures and advanced biometric signatures are also options.
eConsent has different aspects to consider, basically breaking down into three specific types.
Regulatory compliance involves understanding the difference between eConsent and eSignature. Most countries that primarily conduct trials and clinical investigations will accept eConsent. Not all countries, however, accept both for all clinical investigations. Only a few countries have specific guidelines for these processes.
A few deciding factors can help you determine if you need consent in your trials or investigations. Questions to ask include the following:
The following are a few examples regarding eConsent.
The following are several FAQs regarding eConsent in a medical device clinical investigation.
The age of paper is now past, and eConsent is how clinical investigations will continue to progress in the future. eConsent is already in use for enrolling participants in clinical research and medical device clinical investigation.
Reach out to us and let us help you determine the feasibility of applying eConsent to your study design - We're here to help.
Páll Jóhannesson, M.Sc. in Medical Market Access, is the founder and Managing Director of Greenlight Guru Clinical (formerly SMART-TRIAL). Páll was previously the CEO of Greenlight Guru Clinical where he led the team to create the only EDC specifically made for medical devices.