Paper presents an ongoing Source Data monitoring challenge, especially for multicenter clinical trials. Paper records are clunky, locked off on site, and not a particularly secure way to keep Protected Health Information (PHI).
With all those drawbacks, why is paper so common in clinical trials? Having worked across many different sites, we see three common reasons we deal with so much paper: paper-originated source, electronic health records, and tradition.
Paper-originated source is self-explanatory. It started that way – why change it? If you have a worksheet you filled out with a patient, it makes sense to just toss it into the subject binder and let the monitor worry about it later. That makes remote monitoring difficult unless you redact and send via FedEx or email, but why worry about that now?
Electronic Health Record (EHR) systems are (ironically!) a major cause of paper source documents. In multicenter trials, CRA access to the EHR is inconsistent. While some centers will allow CRAs remote access, there is no guarantee. As a result, Clinical Research Coordinators (CRCs) at many sites will print records for monitors. Another reason CRCs print from EHRs is to maintain a research-specific record. Data collected for research can be more simply connected to a particular set of source documents instead of pooled with all of the other medical data in the EHR. However, there may be issues with the validity of source printed from the EHR… (spoiler: see part 2).
Tradition is the last reason. Clinical research predates EHR systems, and many CROs hold to the idea that “if it isn’t on paper, it isn’t source.” This approach is out of compliance with FDA. If your source review involves looking at printed copies of electronic documents, it may not be sufficient. If you’re monitoring against printed copies that haven’t been validated, you’re not looking at a valid source document. Why get on a plane to do that?
Certified Copy addresses these problems and is a pathway away from paper. We’ll take a closer look at certified copy in part 2 of this blog series.
This post is part of our series, “Using Certified Copy in a Clinical Trial”.
Posts in this series:
Part 1: The Paper Problem
Part 2: What is Certified Copy?
Part 3: What’s Possible with Certified Copies of Source Data?