Noted.

I find that one significant gray area in clinical research is the use of the Note to File.  There are numerous situations that may or may not require the use of an explanatory Note to File, depending on who and when you ask.  Generally the Note to File should be reserved for situations where something has occurred over the course of the study that cannot be explained sufficiently using the documentation already present in the chart (or file/crf/etc...).  The point of the Note to File is to provided clarification so that an auditor or outside reviewer can understand a situation, see what was done to correct it, and move onward with few or no questions.  The problems with Notes to File, however, that I see are twofold:

1) Notes to File (and one of my pet peeves is incorrect pronunciation of the plural...it's Notes to File, not Not to Files.  Welcome to middle school grammar) are often written poorly with too little or too much information. 

2) Charts will have either too many or too few Notes to File to explain situations in the trial.

 Notes to File should ideally be concise, well written grammatically, and informative.  They should not be filled with flowery language and should not go into great detail explaining something that an auditor would already know.  For example auditors should understand the protocol, so one should not describe protocol procedures related to a note to file in great detail because the note will become too wordy and likely confusing to the reader.  Ideally, a Note to File will identify what the problem is, how it was fixed, and what was done to prevent it from occurring in the future.  Anything that goes outside of this is a furbelow.


Secondly one should exercise good judgement when creating Notes to File.  Too many of them will raise a red flag to an auditor that there were many mistakes in a study, too few will not adequately address mistakes or issues with the data/study files/etc. A good rule of thumb is to write a Note to File when a situation arises that cannot be explained by a progress note (ex. regulatory binder issue) or when a mistake occurs that has implications for the entire study (ex. consent error or dosing error) if not corrected. 

It is confusing for inexperienced coordinators to decide what merits a Note to File, but it is important to learn so make sure you ask an experienced staff member if you have questions.  Remember  that even though a Note to File is useful for explaining sticky situations,  it is also an indication of a discrepancy or mistake in a trial and should not be used liberally.