Notes to File (NTF) are useful in the documentation of events that a reviewer may find
confusing. NTF need to be well written, relevant, timely, address the root causes of problems
and minimize their recurrence. It is important the NTF corrects the root cause of the problem,
not just document it. NTF also help a study team to recognize patterns and change policies and
procedures, if necessary. File NTF with the document it refers to, either in the subject or
regulatory files. Ensure there is a consistent, logical system for filing the NTF.
Sample Note to File:
<print on Department Letterhead>
Date:
<date that the Note to the Study File is written>
To:
<protocol number followed by ‘Regulatory Binder’ or ‘Study File #’>
From:
<name and title of person writing the NTF along with their signature>
Issue:
<description of problem>
Root Cause:
<why did the problem occur>
Corrective Action:
<how the existing problem was solved, by whom and when; if the
problem cannot be solved, i.e. missing data, document the attempts
to obtain the data and note the data is unable to be captured>
Resolution:
<how the problem was solved, by whom and when; may be the same
date as the memo>
Additional Information: <comments or other relevant information>
16-Apr-13