By: Camila Matheny and Andrew Mackinnon
One of the most common questions we’re asked about eConsent (digital or electronic informed consent) is: What does the ICF amendment or revision process look like within a digital platform and is this harder or easier than traditional paper-based approaches?
I’m sure we are all familiar with the paper process, and the inherent challenges this poses:
Make all the updates to the paper consent form required from the protocol amendment, updated safety information or other study change
- Submit for IRB/ECs approval, or possibly notification where the changes are minimal
- Distribute the approved version to sites
- Try and track down all existing paper copies of the now obsolete paper consent form at the site to remove them from use
The traditional paper process requires a lot of communication between monitors and sites during the distribution of the new ICFs and retirement of old versions. The challenges with this process are clear when reviewing regulatory inspection data. FDA inspections highlight the consent process as resulting in up to 38% of 483s issues, with the EMA inspections highlighting consent issues as the 4th highest cause of critical findings. A significant number of these result from the use of the incorrect consent form, or the lack of a robust process around the consent versioning and use at site.
So, how different is the digital informed consent process, and can this process help with some of current paper consent challenges? The digital process, also includes the same initial process however has a number of steps that significantly enhance the quality:
Make all the updates to the paper consent form required from the protocol amendment, updated safety information or other study change
- Submit for IRB/ECs approval, or possibly notification where the changes are minimal
- Complete the build of the newer ICF in the digital system (using the track changes can help expedite the process)
- Publish approved version to sites
- Archive the obsolete version preventing it from being used
With modern consent authoring tools, updating a template and creating a new version can be done in a matter of minutes. Building a robust communication plan with the eConsent provider is a key element of success here to ensure that a rapid turnaround of the new template is achieved. The ability to “publish” the new ICF templates, and to “archive” obsolete ICF templates, is critical to the improved quality of the digital process. Gone are the days when the CRA would have to patrol the site, visiting all the different locations where patients are consented, to find and remove all the obsolete copies of the previous version. Sponsors can now take control and guarantee data quality and version control across every single site, ensuring they will always utilize the correct and approved version of ICF templates. This frees the CRA to focus their time on study updates, data review and training instead of hunting out stacks of paper!
While the revision and approval process is not much different whether using paper or digital informed consent in a clinical trial, the communication and distributions of each of them are vastly different, with paper proven to result in reduced quality whilst digital being the solution to increase data quality. This public study highlighted just that, with eConsent resulting in zero deficiencies and researchers concluding that eConsent had a significant association with improved completeness compared to paper consent
Sponsors, and sites, looking to avoid some of the pain points associated with the traditional paper consenting process, and especially those associated with amended forms and re-consenting, are more and more looking to a digital solution especially given the broader benefits we have highlighted across this blog series.
https://www.centerwatch.com/articles/26539-study-supports-implementation-of-econsent-finding-benefits-over-traditional-methods
CAMILA MATHENY, EXECUTIVE DIRECTOR, DCT OFFERINGS
An expert in clinical trial operations, Camila works closely with pharma, biotech, and CRO customers to articulate the value of adopting and implementing digital technologies to deliver decentralized and hybrid clinical trials. As a member of the SCDM eSource Consortium, DTRA, and EFGCP, Camila leads with data, the driving force behind bringing new therapies to market. With over 15 years of clinical trials experience, a background in data management, and a passion for the latest cutting-edge technologies, Camila provides a unique combination of expertise to help guide customers towards a better way to adopt and implement technologies the most impactful and sustainable way.
ANDREW MACKINNON VP, GM, ECONSENT
As General Manager for eConsent, Andrew Mackinnon oversees the development of the eConsent product, as well as the implementation of eConsent in Medable studies, ensuring that Medable’s clients can run high quality, effective and efficient decentralized clinical trials. Andrew has 20 years of experience in managing clinical trials at large Pharma, Biotech and CRO companies, most recently as a Senior Director in one of Covance’s therapeutic area delivery groups and as Head of Business Performance. From his involvement in one of the earliest deployments of decentralized methodologies, he has been passionate about the benefits that this approach can bring in reducing the burden of clinical research on both sites and patients and looks to leverage his broad operational expertise to improve how this approach is utilized.
