Reducing Regulatory Risk with eConsent

October 11, 2016

The paper-based informed consent process is widely-acknowledged as one of the most-cited regulatory deficiencies in clinical trials today.

Interest in Electronic Informed Consent (eConsent) is increasing, supported by industry groups and regulatory bodies due to its ability to improve consent compliance, validate participant comprehension and provide an accurate audit trail. 

In this short video, 30 year industry veteran Sandra "SAM" Sather, discusses the impact of informed consent regulatory risks and how eConsent technology holds the power to minimize and, in some cases, eliminate them.


Sandra "SAM" Sather’s current focus of consulting is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She has over 30 years of clinical experience, has a Bachelor of Science degree in Nursing and a Master of Science degree in Education with a Specialization in Training and Performance Improvement. SAM has been dual certified by the Association for Clinical Research Professionals (ACRP) for over 10 years as a CCRA and CCRC. She is a current member of the ACRP Academy Board of Trustees, and ACRP Regulatory Affairs Committee (RAC); SAM has been a clinical research coordinator, site manager, sponsor and CRO monitor, auditor, trainer and quality manager. She has multiple training, monitoring and project management experiences of diverse size, and objectives with a variety of global clients. She is a frequent speaker at industry conferences and has authored dozens of courses for clinical research training programs. In 2002 she co-founded Clinical Pathways (CP), LLC. 



Informed consent is one of the top cited regulatory deficiencies by the FDA.

Reconstructing and evaluating the consent process is very hard right now, because it’s very handwritten, and it’s very difficult for a regulatory authority to see that a patient was adequately consented.

For example, one study might have 100 sites and 100 different informed consents to approve.

And so the study coordinator who commonly is scheduling the patient and getting the consent ready, it’s—it’s not uncommon that they might choose the wrong version or the wrong study consent. And in paper it’s not that easy to tell. One version could look very close and similar to another. So there’s really no stopgap for them that is concrete to not use the incorrect version.

When we develop an electronic informed consent, the electronic system actually date-time stamps and creates an approved version, so there’s no other version available to the site. So it’s very site specific. So there’s no way for them to use the wrong version.

Another compliance issue that’s very common in informed consent is the completion of the consent is done incorrectly. So some informed consents require initialling of patients every page, or multiple signers. And in a paper document it’s very easy to flip over a page and not do the required initials. In an electronic system, it would prevent the person from progressing further into the eConsent, by having to complete and answer a question before they move on. So a lot of the mistakes in the documentation or the filling out of the consent can really be helped a lot.

I think there’s many studies that we do a lot of redo. So the cost of doing it correctly in the beginning, where we could monitor it early on, would be a great improvement.

So ah, having the ability to meet the HIPAA requirements is very important. So having password protection, having audit trail. Ah, meeting the 21 CFR Part 11 compliance is really important.

The—the two ma—major goals of the FDA are to support human subject protection and data integrity. And the informed consent process is really one of the starts of all that. So if we do that better, we can better support patients and also have better data. 

FDA Supports Innovation in Clinical Trials with eConsent
FDA Supports Innovation in Clinical Trials with eConsent

How eConsent Improves Consent Development
How eConsent Improves Consent Development