
Electronic vs. paper: hybrid approaches for modern sites
Evaluate the trade-offs between paper, electronic, and hybrid document management approaches, including 21 CFR Part 11 considerations and certified copy requirements.
Two binders, one study, no agreement on which is official
It is 2026. A coordinator at a mid-size research site opens the electronic regulatory binder system on the desktop monitor, clicks into the personnel section, and confirms that the principal investigator's current CV is uploaded -- signed, dated, PDF. Then the coordinator turns around, opens the physical three-ring binder on the shelf behind the desk, and flips to Tab 2. There, behind the "Investigator and Site Personnel" divider, sits the same CV -- but this one is a paper original with a wet-ink signature.