Discover Why Electronic Revisions Of ICFs Are Easier

By Camila Matheny and Andrew Mackinnon

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? Paper consent revisions involve updating forms based on protocol changes, securing IRB/EC approvals, distributing new versions to sites, and tracking down old forms, which often leads to errors and regulatory issues. Regulatory inspections, such as those from the FDA and EMA, have shown that paper-based consent issues contribute significantly to compliance violations. In contrast, the digital ICF process simplifies updates by allowing sponsors to build new forms quickly using modern consent tools, publish approved versions, and archive obsolete ones, eliminating the need for physical removal of outdated forms at sites. This automated version control ensures higher data quality and reduces human error. By shifting to digital consent systems, clinical trials experience fewer deficiencies, improved completeness of forms, and greater efficiency for Clinical Research Associates (CRAs), allowing them to focus on more critical tasks instead of managing paperwork. The shift to eConsent is increasingly seen as a way to address the pain points associated with traditional paper-based consent processes, especially during amendments and re-consenting.