hey guys ECR G here and today we're gonna talk about a note to file hey guys
ECR G here and today we're gonna be talking about a note to file now what
exactly is a note to file a note to file is a file that is filed in the TMF that
specifies why a mistake was made why a particular document isn't there why a
date on the on any form and the TMF is wrong
etc if something is wrong there's a discrepancy on a form in the TMF a note
to file is created to then explain away that discrepancy say why the discrepancy
is there and that's basically what it is a note to file is called many things
I've heard memo to file or MTF obviously note to file or NT F or just a file note
so most common I would say is probably note to file or memo to file but if you
hear any of those words there's just the same thing now the purpose of a note to
file is to in fact improve data quality I'm confused
at how this is the case if you know what the thought process is for that you can
comment down below or it can convince me otherwise but I'm not convinced that
note to file somehow improve the data quality for a multitude of reasons first
reason being it's just a band-aid for the root problem if a document is
missing the document should have been in there that's in fact the opposite of
improving data quality because the document is not there it's decreasing
data quality because we're just putting we're just putting a note to file in
there saying that the document is not there and providing something excuse for
that reason that's not improving data quality that's the opposite in my
it's not really fixing the problem at hand it's providing a band-aid measure
for the root cause the root cause for a document not being there is because a
CRA didn't collect the file and submit it to the rest of the project team to be
uploaded into the TMF or it was lost in translation or something like that
so teams need to focus on the structural and the systems approach and why
documents are missing or discrepancies are made and focus on that so that the
whole organization as a whole can become better and all the project teams across
the whole entire organization can become better for that reason so no-till files
are more just a band-aid remedy at the at the time and not really a structural
infrastructure solution to improve clinical trials in the research
altogether so if you imagine if you have a lot of notes of files in your TMF how
strong can your data be if you have so many missing documents so many
discrepancies even though for some of the reasons for example a version number
a notes a file can be helpful for just plopping that on top and saying hey this
file should have this such-and-such version number it should be version 2
instead of printed version 5 on there so that can be helpful to explain that but
for notes of files for a complete missing documents or missing folders
that's just unacceptable and that's just more of a band-aid approach and in that
situation there needs to be a more ground-up fundamental difference in the
approach to correct that going forward not just being okay with providing notes
of files so some common reasons I've seen for writing note 2 files are if you
don't have p.i GCP training if it's not signed and dated in the TMF by the p i--
then a note to file is written and you can't get ahold of the PI for whatever
reason or the site has closed down same thing with sub i's i'm a lot of
signatures if you don't have the proper things signed and dated then a note to
file is in order if you can't get ahold of the CRA or the site again just just
simple things like that sometimes if you don't have whole documents like I said
if you don't have PID CP training and the site has closed down I mean it
should have got been gotten a long time ago but a notes a file can be written to
explain why it's not there so things things like that a reason to why you
have would have note to files on a more common basis alright guys that's it for
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