hey guys Serg here and today we're gonna be talking about most common mistakes I
see in the TMF
hey guys II see RG here today we're going to be talking about the most
common mistakes I see in the TMF now the TMF is a huge topic in clinical research
because it is the big file it is the most important deliverable it is the
deliverable that is handed over to the sponsor and is reviewed over and over
again and it has everything in there from the meeting minutes from all of the
site delegation logs all the IP temperature logs all kind of different
logs FDA 1572 investigator brochure protocol signature pages that goes on it
houses everything in a clinical trial so it is very important and oddly often
times throughout the course of a clinical trial these things go on for
years there are random intervals at which the team will stop everything
come bring everybody together project manager lead CRA maybe some CRA s maybe
some in-house CRA s and any other people that are working on the trial they'll
stop everything and take inventory of what is in this trial master file and
what is not there so that's called TMF reconciliation and today I'm a list some
of the common mistakes I see in the TMF that I'm constantly you know submitting
queries for correcting reaching out to sites reaching out to CRA s to see if
they can correct it or find a better version of it so here are the most
common mistakes that I see number one is naming and this is just a simple you
know formatting error someone doesn't know how to make correct ly in the TMF
and you know usually they follow a specific format but it can be to sponsor
dependent based on how they want it named because it is their TMS but
they're paying for so they can determine how they want it but usually there's a
kind of convention that it follows and it's the location in the TMF so we could
look anything something like you know s dot 0.06 dot point o4 so
it'll be that location that specific folder then it'll be underscore then
will be country followed by the site number so let's say you know Belgium
it'll be BL say site three be elo three then it's usually followed by the p9
last name and then it's followed after that on the document name so let's just
say s IV confirmation letter and then usually the date is last so they usually
follow a specific format and it can be dictated based on the study and the
sponsor but usually there's a specific format that's going but gone by and the
most common error I find is that it's not in US with the specific format that
it needs to be in people just throw it into TMF any kind of way so when someone
is doing team at reconciliation they have to go in there and change the name
because the name is important and the naming is important you want everything
to be consistent really so one document has the same kind of naming format as
the next document in the next document and that's the most common mistake I see
in the TMF actually it's easy to make and that's probably why that's the most
common mistake I see second is the problem I see with actual documents and
it's signatures being cut off this happens surprisingly a lot probably see
arrays are quickly fumbling to scan documents in to to their computer and
just mistakenly you know honest mistake mistakenly cut the signature off and the
date - usually they're on the same line so normally we have to ask them to
rescan it or ask the site to send a clean copy over
so signatures are something that's common that's cut off and those are
important because you need to have a signature and date on pretty much
everything and you know exactly that something that is very important and and
usually you know can make a break the document if there's not if it's not
there then they're going to want one is there well there have to be a note to
file filed and notify will make it later on this list the third most common
mistake I've seen the TMF is missing documents now this really isn't a
mistake per se but oftentimes there are documents that should be there that are
not there for whatever reason for example if I have a if I have an S if
I'm looking at the S ID section I have an S IV report and a follow-up letter
well it's clear that I need a confirmation letter because the
confirmation letter was written before the visit actually took place and we
know the visit took place because we have a follow-up letter and a si B
report so we know that the confirmation letter should be there and it's not
there so that's an issue so we've got to rectify that by maybe it's in some
folder or something or maybe the CRA has it or something like that but that's
something else missing documents is another common one and then the fourth
common mistake I see in the TMF is note to files for things that there shouldn't
be with the files for we got to stop getting into this habit of writing milta
files for for just any miscellaneous thing I feel like Note 2 files our way
used way too much in clinical research and you know if you don't have a
document then you need to really get that document in like there's no excuse
for it usually usually there's not a good excuse for why you don't have a
document and you know it gets to the end of the trial and I just want to kind of
get it over with so they just write notes of fouls for everything every
little error there's a note to file for it and you
know that's just typically how it's done you know after years and years of work
you just kind of want to get it over with
so you know that's why notes a thousand written and they're very rarely written
for something that can't be rectified with a little bit more effort but uh you
know those are right that's my big for the most common mistakes you see in the
TMF so they'll go over them again we've got naming conventions we've got
signatures and dates being cut off we've got missing documents and fourth we got
notes of files so that's pretty much it from
kind of mistakes I see in the TMF watch you guys comment down below what
comments you see in the TMF what mistakes you see in the TMF comment
those down below in the comments section go ahead and like this video share it
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care