It is not unusual for a monitor to come across upwards of a dozen Notes-to-file at a monitoring visit. At some sites it can seem as though the art of the Note-to-file is perfected as a Magic Eraser with regard to explaining away regulatory discrepancies. The regulatory purist in me shudders at this practice; but at my last monitoring visit, I stepped out of my normal comfort zone and recommended that my site staff colleagues compose several Notes-to-file to document resolution efforts that would otherwise be doomed to follow-up item purgatory. A Note-to-file should not be the immediate solution to a nagging regulatory issue, but there are several instances that can elevate this documentation tactic to preferred status.
So, when is a Note-to-file appropriate?
- To document the location of sometimes-centralized essential documents, such as CVs, medical licenses, laboratory certificates, and clinical trial agreements/budget agreements; or to note the location of a log that might be updated and stored outside of the regulatory binder for the site’s convenience
- To document a specific site practice that is otherwise unusual or unclear
- As a way to document efforts to resolve a potential deviation or non-compliance that has become otherwise unresolvable
To elaborate on the final point, it can be conceded that there are times when certain situations can result in regulatory discrepancies that have no hope of resolution. For example, consider a situation where you are two years into a study and cannot locate training documentation for staff that performed study-related tasks and no longer work at the site. After doing some investigating, you determine that they cannot be located and, unfortunately, there is no copy on file with the sponsor. In this situation, a properly composed Note-to-file will not correct the fact that the documentation does not exist, but it may keep you or someone else from having to go down the same investigative path in the future. In this circumstance, what should be included in the Note-to-file?
For these more complicated regulatory issues, Notes-to-file should describe in brief:
- A summary of the problem or discrepancy
- The action that was taken to resolve the issue
- Why the actions failed to resolve the issue
- Any issue the site has taken to prevent a similar circumstance in the future
- Date and signature of the Research Coordinator and/or Primary Investigator (depending on the severity of the issue documented)
However, if there is a repetitive history or major regulatory non-compliance, it might be in the best interest of a site to complete a Corrective Action Plan and include the Note-to-file. The presence of a Note-to-file will not necessarily stave off a Warning Letter, should the non-compliances be severe enough. There is not a Note-to-file in existence that will take the place of proper staff training and solid SOPs, nor can it ever be considered a replacement for source documentation.
One final point regarding Notes-to-file: this Magic Eraser does not absolve the site of regulatory reporting requirements. If subject medical records were not reviewed for SAEs in a timely manner, a site cannot simply document the oversight in a Note-to-file and claim the issue resolved. Sponsor, IRB and FDA reporting requirements must still be adhered to.
How does your organization handle Notes-to-file?