A Note to File (NTF) is a record that allows the clinical site and the sponsor to document an identified issue or discrepancy during a clinical study. A NTF should include the following items:
· The root cause of the discrepancy/issue
· The corrective action taken to prevent its recurrence
· Explanation of how the corrective action has resolved the problem
Depending on the issue or discrepancy a NTF can be recorded for study participant(s) or overall study related documents. The NTF should be filed in the subject chart if it is relevant to the subject and if the NTF is relevant to the study, it should be filed in the applicable section of the study binder.
The most common events that a NTF may be appropriate are
· Missing regulatory information/documents
· Missing data in the patient chart
Every clinical site has a NTF template with the organization letterhead. The NTF should be authored and initiated by the individual or organization responsible for its content. Usually the Clinical Research Coordinator (CRC) authors and signs the NTF and the principal investigator (PI) signs it to confirm the accuracy.
The clinical site and sponsors should not depend on NTFs to secure compliance. Having an effective quality system prior to selecting a site and enrolling patients can mitigate mistakes during the study. That’s why the sponsor needs to make sure that the study staff and the PI are well trained on the protocol and are aware of their responsibilities.