hey guys ECR G here back with another video today we're going to be talking
about what is an annotated report in clinical research
hey guys Serg here back with another video this might be a short video today
today we're going to be talking about what is an annotated report in clinical
research now for you guys interested in the monitoring aspect the clinical
aspect of clinical research this is something that is very very important
but before we go ahead and get into that I'm gonna talk to you guys about the
resume review program we have going on right now this is a program where if you
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back to the annotated report the Entertainer report is a document or an
outline of how a monitoring visit or monitoring call should go and it has all
of the bullet point that a monitor is gonna want to hit during the visit so
that is an integral part I'm gonna deconstruct one a little bit later where
we go into a little bit more detail on the different thing the different
questions you might ask but it is basically a list of things that you want
to hit so you want to talk about subject recruitment you want to talk about you
know randomization how the randomization process is going you want to talk about
informed consent you want to talk about training of the site staff have they all
done their training so there's gonna be a huge list of things that are on that
annotated report that a monitor is gonna get when they're new to the study by the
CTL the clinical trial lead and they're gonna be given this document to make
sure that they hit all of the things that the sponsor wants them to hit and
the study team wasn't to hit during the monitoring visit and then to make sure
that's covered throughout the duration of the study throughout the duration of
the visit and it's really important because you want to make sure that when
your monitor goes on-site or your monitor is calling the site for
monitoring call that everything is covered and that they do a thorough
visit because a lot of times they're not going to be seeing the site for at least
another six to eight weeks if they're talking about going on-site or if
they're a remote monitor or in-house CRA these visits typically happen once a
month maybe once every six weeks depending on what the sponsor wants and
the sponsors obligation for that so it really just depends but every time you
do a visit you want to make sure you're as thorough as possible to ensure that
the data is being monitored correctly and everything is being monitored
correctly so that by the time an audit happens or if it not it happens by the
FDA you know all the T's are crossed and the I's are dotted and when it comes to
the clinical study so typically the clinical trial lead or the lead CRA is
the one who comes up with an annotated report and they may do it in conjunction
with the project manager and obviously in conjunction with the sponsors team
because they are the ones paying for the trial and they are the ones who are
probably going to be overseeing the monitoring aspect because that is one of
the most important aspects of the trial they want to make sure that at every
visit whatever they need covered is going to be covered so they're typically
going to be looped in and involved in that process as well and this is gonna
happen you know before monitors come on to the study so pretty early in the
process of a clinical trial they're gonna start working on this and you know
it's a really good form it is something that you know I use as the basis for my
monitoring visits and then obviously as you go through the trial there's gonna
be other questions that pop up throughout and obviously this this is
you know kind of a living breathing document as a protocol gets updated
they're gonna be more questions you need to ask or this can this document can be
amended throughout the study depending on what needs to be changed or added to
annotated report but it's kind of a misnomer because it's not necessarily a
report but it's basically a template for the monitoring visit report that's why
it's called an annotated report it's essentially a template for the
monitoring visit report so you know there's a lot of information on there
they're pretty you know they it's pretty high level just just basically a
template or scaffold for how a visit should go and all the topics that should
be discussed so hope that helps comment down below if there are any questions
with annotated report or dealing with the annotated visit reports and email us
Ally clinical Group at gmail.com for any increase you may have resume review
program it is up there as always guys follow us on the podcast subscribe to
this channel like this video share this video watch it a few times if you're a
little bit confused about annotated visit reports and comment down below any
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take care