Developing informed consent content requires a lot of back and forth communication between multiple stakeholders - an inefficient, slow process with a history of allowing unapproved or out-of-date consents to be accidentally deployed to sites.
Electronic Informed Consent (eConsent) offers a streamlined, collaborative process that promotes faster content development, approval and deployment on one platform, guaranteeing that only the most current and approved consent version is used each time.
Watch this short video to learn about the improvements that eConsent brings to the consent development process.
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.
It’s a very ah, difficult laborious process to develop an informed consent.
It takes a lot of time, a lot of back and forth communication. So if we could streamline that with an electronic collaboration design, it really could help save time and money.
Currently the process is paper, so it’s Track Changes on documents, there’s a lot of ah, sharing information back and forth, version control challenges as well.
In the development of the consent, the institutional review board for this site, the research ethics committee, needs to approve the version that needs to be used for the subject, for the patient prior to study procedures. And ah, sometimes it does—they use the wrong version of the consent.
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, unlike paper which is very possible.
In the consent development process, sponsors typically use a standard operating procedure template that they are required to use.
In some cases, in paper—and electronic—if some of that content has already been used on other studies, we can repurpose it.
Why re-approve something that has been done again and again.
Being able to support getting an informed consent developed quicker, approved quicker, and also to ensure that we have more compliance with patients being enrolled in our studies, and that when they’re being enrolled, they’re much more informed.
Errors in informed consent are very costly. So by not using the right version, by having to re-consent or lose patients because of not getting adequate consent, we could lose data. So— which is—it costs a lot of money. So by doing consent right the first time and then supporting the patient as they move throughout the trial with consent, is—can really save us a lot of money.