hey guys ECR G here back with another
video today we're going to be doing a
recap of the first ever clinical
research associate monitoring call to a
site my first ever clinical research
associate monitoring call
hey guys ECR G here today we're gonna be
talking about my first ever clinical
research associate monitoring call now I
know a lot of you guys out there in the
youtube sphere and the podcast sphere
just people of the internet in general
are interested in becoming si Ras or
Clinical Research Associates and the job
is slightly changing a little bit
we'll see this predominantly over the
course of the next few years but even
right now we're starting to see some
changes to the role and the changes are
predominantly because of the IC HG CPR
to guidelines that have been issued that
came out in 2017 so basically see Ras
are going to be in charge of doing risk
based monitoring and all people on the
clinical operations side and what that
is is really a philosophy on using data
to better monitor sites and one of the
things that they found is you do not
have to go on site for every little
thing and in fact you can actually
monitor sites remotely you can do a good
deal of monitoring remotely so what we
can do remotely we're gonna do remotely
and what we have to go on-site for we're
gonna go on-site for so you've seen the
in-house C Ras or Central monitors or
clinical monitors the in-house CRA job
they're gonna be doing a lot of remote
monitoring but also certain companies
depending on how they're set up see Ras
field monitors are going to be doing
remote calls as well potentially and
also there may be some hybrid roles that
come out where I know some companies may
have already implemented this where you
are part CRA part and how CRA which may
be good for those people that don't like
to travel but you still get a little
taste of traveling every now and then
but basically the first monitoring
caller the first time you do anything is
gonna be a little struggle it's gonna be
a little you know taking some time to
get used to so I mean that's that's kind
of how my first call was
I felt pretty prepared because all you
have to do is follow the annotated
report and I felt like my training
program was pretty long you know being
trained to do this it was pretty long
but it could have focused more on I
guess mock calls mock visits and that
would have been extremely beneficial so
basically my first call was my first
ever call and you know the awkwardness
and the nuances of that so basically I
was given an annotated report and the
annotated report has basically has all
the questions you should ask or all the
blanks you should fill in when talking
to the site so it's gonna have things
about you know patient recruitment how's
the site doing with patient recruitment
it's gonna have things about informed
consent
what's the version number of the
informed consent you know what informed
consent if there's a if it's a pediatric
trial they're gonna have you list assent
forms and what when it was signed and
all this stuff they're gonna have you
ask questions about you know is do they
have the site having an IP that's
expired
that's investigational product you know
and question questions like that you
know are there protocol deviations are
there adverse events etc etc so you know
pretty much on my first call I was going
down that annotated report and it's
funny because you going from call to
call as I know now having much more
experience with that I mean I don't even
specifically I was asking the questions
pretty much verbatim as they were listed
on that annotated report but now I don't
even ask those questions now I know more
subtle questions to ask to get the right
answer and more direct questions to ask
to know what I'm looking for so it's
just like anything the more you do it
the better you're gonna get and you know
the annotated report is a good guideline
to follow especially when you're new to
a study when you're new to being a
monitor in general so I was pretty much
just following the annotated report on
down and you know typically on the first
call you may have someone else listening
in besides the study coordinator to make
sure that you're not
doing anything crazy and to essentially
sign you off so that's very popular in
the monitoring world as well you're
gonna have to have someone sign you off
so the so the thing that they do is you
watch one so you watch people do it then
you do one you do a few yourself and
then you teach the next group of people
to do it so I guess it's watch one do
one teach one is the philosophy that
people say in the monitoring community
so you know I watched I watched a few
but I feel like I really learned from
doing so that's actually doing it this
first one was a huge learning experience
didn't feel too nervous about it
because I've had a lot of site
interaction before I've been in you know
tasked with reaching out to sites for
recruitment issues that they may have
and you know by that point by the time I
had my first monitoring call you know I
was pretty well versed in contacting
sites so I didn't feel any nervousness
around that the nervousness started to
come around when the site would ask
questions that I had no idea the answers
to or even questions that I should know
the answers to but I don't know the
answers to but I find that most people
tend to be very welcoming and very nice
and monitoring community there's a lot
of turnover there so you're constantly
getting used to working with brand new
people you know it's it's it's rarer to
find a study coordinator that's been at
the same site for five ten years you
know you may be on a study for a few
years and you may go through two three
four different study coordinators you
know even within a site even within a
department they constantly move people
from one study to another to another to
another so even if they haven't left the
company or the organization they may not
be on your study anymore for whatever
reason so I feel like they're used to
working with people that aren't as
experienced so I'm definitely happy
about that but you know overall went
pretty smoothly monitoring calls can
last anywhere from
about 15 minutes if you're pretty quick
to about you know an hour hour and a
half if you're slow or there's a lot of
queries to go over or a lot of action
items to go over and things of that
nature luckily this first one only lasts
about 30 minutes and you know it's
pretty good to have someone to sign you
off that's actually on the study a lot
of times they may have someone who's not
on the study so they're not as familiar
with the study on the call so that way
if the site study coordinator asks
something that you don't know the answer
to that person's able to jump in because
they're on the study and familiar with
the study and be able to ask questions
so luckily that happened on my call in
fact the person who was listening in
actually jumped in a few times and was
asking questions just for their own
personal benefit for some things that
they were working on so that's pretty
awesome
and that seemed to work out to my
benefit as well so that's that's
actually a tip if you ever get the
opportunity have someone who's actually
on the study listening to your call for
your sign off visit and depending on you
know different companies may do it
differently so it just kind of depends
but that seemed to work pretty well and
the calling lasts about 30 minutes you
know this person was asking the
questions they were helping me out along
the way so pretty low-key affair I was
just more so worried that you know the
site would ask me questions and I
wouldn't know or they would ask me a
bunch of questions and I'd have to go
follow up on a bunch of them but you
pretty much just do your best to do what
you can and that's that so then after
the monitoring call that's when the hard
part is that's when you've got to write
your report that's when you've got a
write your follow up letter so the
report takes about mmm I'd say about two
days to write most people don't write
the report the same day because there's
a lot of information you've got a track
in there in the report you've got to
basically talked about everything that
you talked about on the call so if you
talk about recruitment you've got to
talk about what they say there's what
you know if they say like hey I'm
screening to patients next week and we
plan on randomizing a patient next week
as well you've got to write that down
and you've got to know the specific
patient IDs and you know if they say you
know I'm gonna get the the true week you
know clinical research is really big on
training so if they say something like
hey I got it you know they're missing
some training then you've got to follow
up with them on the training and then
you've got to put that as an action item
usually so there's there's just a lot to
go into it a lot that goes into it and
we'll actually doing more training more
videos on the channel about monitoring
so make sure that you stay by and
subscribe to this channel because we're
gonna be pushing a lot of monitoring
content over the next few months and
really excited about that because I know
a lot of people are interested in
monitoring and becoming CRA s so
definitely stay tuned for that but
overall monitoring experience was good
report was good it's finished took about
a few days then the lead CRA or the CTL
has to review it and to prove it and
then if they approve it then you can
finalize it sign it and submit it to the
trial master file and you and you submit
the confirmation letter the report and
the follow-up letter to the trial master
file and that obviously goes to the
sponsor at the end of the study so you
know it's a it's a process to get
through one but you know as you get more
and more under your belt you're going to
be able to you know do them quick more
quickly and you're gonna get used to
them and you're gonna be a lot better at
it so that's the review of my first
monitoring call didn't it went pretty
smoothly didn't have any hiccups or
anything like that so stay tuned because
one of these times I'm gonna tell you
about a horror story
dealing with that so if you guys enjoyed
this video like share subscribe as
always email us at elites clinical group
at gmail.com for any enquiries you may
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alright guys take care