hey guys Serg here back with another episode I have been doing a lot of
traveling on site recently in the past few weeks and I noticed that I've
recently gone to a string of sites that could really really use some help with
what to expect when a monitor comes on site so today's episode is called
a study coordinators should do this before a monitoring visit so a lot of
people out there interested in becoming study coordinators see arrays or
monitors or you know project managers or whatever the role you might be
interested in but a lot of people have got to understand what goes on on site
when a monitor goes on site so a lot of people don't really know and this
obviously takes some time to really kind of understand what's going on the more
you have practiced and the more you have gotten experience in the clinical
research industry so I'm gonna go ahead and get started here and the first thing
that a study coordinator should do before a monitor goes on site is of
course is enter missing data this is the reason the main reason that a monitor is
coming on-site is to go ahead and clean screen not necessarily analyze but make
sure that the data was collected properly and according to the protocol
and I see gcp that's the main reason why I monitor goes on site you know every
six to eight weeks or ten weeks or whatever the monitoring schedule is but
they're going on for data to make sure that the data has been collected
appropriately and according to protocol so the study coordinator has to enter
the missing data because if the monitor goes on site and there's no data in the
EDC system they can't source data verify now that of course they can do their
sort data review if the data was collected properly but it really really
helps you know so they can lock the database so the data manager can go in
and do their job if the data has been entered beforehand so monitors get
really really frustrated when no data has been entered in to the CRF or EDC by
the study coordinator so that's one of the main things that study coordinators
should do before a monitoring visit is to check to make sure that all the
data has been entered so the second thing that study coordinators should do
before monitor comes on-site is to review the follow-up letter or email
from monitor and complete the action items from the last monitoring visit so
the reason why a follow-up letter is sent out is because it usually contains
the action items which are the items that need to be focused on before the
monitor comes back on-site so these can be things like you know make get a
training form make sure that the site has completed the proper protocol
training maybe they had a new site staff member make sure the 1572 is updated
make sure the delegation log has been updated make sure the PI has signed off
on the delegation log things like that are things that are common action items
that happen all the time and so these are added as action items to make sure
specifically so the study coordinator or the person who is on site representing
representing the site for the monitoring visit has been able to do what the
monitor has asked and get them caught up with regulations and regulatory findings
so that's the second thing is review the action items from the last bit those can
be found on the follow-up letter or if your monitor is nice they may have sent
you an email right after the visit so you have to wait for the follow-up
letter with the follow-up letter oftentimes you know a lot of monitors
send them out late if there are if there no structure in the organization but
they usually send them out a week or two after probably about three weeks
actually three weeks to a month after the previous monitoring visit but I know
these can come out late sometimes they may send out the day before or two days
before so it is up to the study coordinator to ask well in advance of
the monitoring visit if you have not heard from the monitor you know what
they need what you need to do action item was before the monitoring visit so
that would make a good study coordinator someone who is proactive and asked what
they can do beforehand so that's one thing review the follow-up letter and
complete the action items then the third thing and I'm only going to give you
guys three two because we'll do more videos on this in
the future but these are the three main ones first one just to review with enter
data second one complete the action items and then the third one is to
update the ISF binder now of course a lot of these things are going to be
included in the action items but the iossef binder is something that's going
to hold you know the trainings is going to hold
medical licenses CVS ire be documentation any type of sponsored
correspondence it's gonna hold all of these things so you want to make sure
your ISF binder is up-to-date because a good monitor or if a monitor has enough
time is going to try and review the ISF binders before they leave for the
monitoring visit so that's one thing that you've got to do and so when i said
number one was to enter missing data i forgot to mention one thing when you're
entering the missing data you're also responding to queries from the last
monitoring visit so that's all done in what's called the electronic data
capture system a common one is metadata rave that a lot of people use but when
you're entering the data you've got to go in there and make sure that the old
data those queries have been addressed also so that the monitor can source data
verify and then data management can go in and do their review also so those are
the three things that a study coordinator should do before the next
monitoring visit those are the three main things now your monitor may what
like other things to be done there may be some interesting things on the action
items list that may take time and you may not be able to do in time for the
monitoring visit that's fine but you at least want to be aware and at least have
an update from the monitor when they come on site for what has been done and
what hasn't been done so I hope that was beneficial I want to do a lot more
things from a monitors perspective on what sites and study coordinators should
do so if you've got any topics comment down below on youtube or send me an
email elite clinical group at gmail.com if you got any topics you'd like me to
cover take care
you