One of the more difficult tasks for FDA employees is making a presentation to a public meeting. Regulated industry is always interested in what FDA has to say about enforcement of its regulations. There is increased interest by clinical trial professionals because the GCP regulations found in 21 CFR 312 and 812 don’t have the level of specificity found in Good Laboratory Practice or Good Manufacturing Practice. And when you mix GCP with Part 11, the electronic records and electronic signatures regulation, then public interest goes through the roof.

In the past few months I attended workshops where FDA employees gave very different presentations regarding the thorny issue of electronic records used in clinical trials. FDA regulations require clinical investigators to keep “adequate and accurate case histories” for all human subjects participating in a clinical trial. The problem for many studies, particularly inpatient studies, is that the records are kept by an institution, not the clinical investigator conducting the study. The institution maintains the records as part of the practice of medicine. FDA does not regulate hospitals or the practice of medicine, only the records that are required for a clinical trial. Up until now FDA has been very careful not to initiate jurisdiction over the electronic medical records (EMRs) found in many hospitals and medical centers.

To help researchers maintain accurate records and utilize computerized systems, FDA published a guidance document, Computerized Systems Used in Clinical Investigations (May 2007). This document gave a specific definition for a “certified copy” that researchers could make from electronic or other records: “Certified Copy:  A certified copy is a copy of original information that has been verified, as indicated by a dated signature, as an exact copy having all of the same attributes and information as the original.”

So I was rather surprised when I attended a presentation that didn’t mention this definition but instead featured a slide stating: “’Certified copy’ -copies of records must be generated using a verified process that produces copies with same content and meaning as original record.”  The speaker also suggested that FDA could assert jurisdiction over hospital EMR records, something I had not heard before.

I wanted to know just what was meant by “a verified process” and just where was the information available? My question went unanswered. I was particularly concerned because I had published an article in Applied Clinical Trials and I was worried what I had written was either inaccurate or out of date. Then, a few weeks later, I attended another workshop with another FDA speaker. This time there were no surprises and “certified copy” was just the way I had read it in the guidance document. The speaker said that FDA was not going to assert jurisdiction over EMRs in the immediate future. That made quite a difference between the two presentations.

There are two important things to remember about computerized records, including EMRs. First, FDA has scaled back its enforcement of Part 11. In August 2003 FDA published a guidance document that limited FDA’s oversight of computerized records. This document, Part 11, Electronic Records; Electronic Signatures—Scope and Application, announced that “FDA is re-examining part 11 as it applies to all FDA regulated products.” In this document FDA announced that part 11 would be “interpreted narrowly” and that FDA would “exercise enforcement discretion.” FDA stated, “we anticipate initiating rulemaking to revise provisions of that regulation.”

Second, FDA is working hard to update part 11 and has internal work groups doing just that. However, FDA has a rulemaking process and any changes would need to be published in the Federal Register and opened for public comment. That hasn’t happened yet. Until it does, the safest thing to do is to rely on the two guidance documents that FDA has published. In using EMRs researchers should use a risk-based analysis of the system and what data are being captured. Research can’t grind to a halt because of the use of EMRs. But it is the responsibility of researchers and sponsors to make sure that their records are “adequate and accurate.” That’s a difficult thing for anyone to explain, including representatives of FDA.

For more information, please see:

Computerized Systems Used in Clinical Investigations

Part 11, Electronic Records; Electronic Signatures—Scope and Application