hey guys have you been getting confused about what these terms are remote
monitoring traditional monitoring risk-based monitoring well in today's
video we're discussing remote monitoring so what is remote monitoring
hey guys Serg here back with another video today we're going to be discussing
remote monitoring what is remote monitoring so like you see in the stock
footage here you've got a phone a landline device and obviously remote
means from far away or in a different location than so you're gonna be
monitoring the site the site P I study coordinator whoever is at the site site
personnel and their data remotely so why is this important
well with the new IC HG CPR two regulations that went in place in 2016
2015 the industry is just now catching up with those regulations and it has
opened the door for what is called remote monitoring as well as risk-based
monitoring but we're not going to confuse you there today
remote monitoring is a style of monitoring to be used in conjunction
pretty much with traditional monitoring but usually they'll have someone like a
remote monitor who can do a lot of the things that the CRA normally does
on-site remotely because the CRA only have to go on site for a few things one
to talk to the P I face to face and a study coordinator face to face if they
want to get that face-to-face connection which is always important that will
never be replaced by you know for Skype WebEx phone the face to face we'll never
get replaced so that is very important so don't underestimate that but the two
things that a CRA has to do on-site that can't be done remotely right now our IP
accountability so they've got to check the IP they've got to check that the IP
is being stored correctly they've got to check that the number of pills have been
administered like they say in the system you know like the study coordinator has
been reporting and rave they've got a or on the source documentation they've got
to say that you know the IP matches up there the investigational product
matches up there so that's the first thing I P accountability the second
thing is source data verification so whatever forms that the patient is
filling out or the study coordinator is filling out whatever medical records or
anything that's collected there they've got to check that versus what's entered
in the Rea into the EDC electronic data capture system I keep saying rave
because that's a popular one that I've got a lot of experience with called
metadata rave so they also make a CTMS a clinical trial management system but
they're famous for you know their clinical trials applications that are
used widely throughout the industry so those are the two things a source data
verification and IP accountability that series must do on-site now everything
else if we're talking document collection unless they want wet inks
then that has to be done on-site as well but typically document collection can be
collected remotely so if an if a new study coordinator is coming on to the
study they're gonna need a financial disclosure form they're going to need
you know that documentation so they have to send that into the CRO they're gonna
need any type of license licensure if that person's person is licensed by any
body if they're a nurse they're gonna want that license they're gonna need a
CV of that person they're gonna need their ICS GCP training conformation so
all of these documents have to be submitted to the CMA or CRA and put into
the trial master file and we know we've done videos on the TMF before if you're
new to clinical research but all that stuff has to be collected and the CRA
does not necessarily have to be on-site to collect them so that can be done by a
remote monitor so I mean there's a number of things that can be done
document collection is one of them also they can review the data in the
electronic data capture system they can they can issue queries an electronic
data capture system this can all be done remotely so this all goes into remote
monitoring when they were basically monitor the data make sure it's accurate
make sure it's coming in on time because that's a big thing sometimes sites like
to enter data late and sponsors don't like that they want to be able to
analyze the data as coming in in a relatively efficient and
quick manner to see if there's not going to be any problems or foresee any
problems in the future so you know that's basically what a remote monitor
is they're gonna be doing anything and everything and this can be they can be
conducting monitoring calls monthly monitoring calls or however the window
is that the sponsor would like sometimes its monthly sometimes it could be
bimonthly sometimes they can be bi-weekly just depends and not even all
studies do calls some are email based I've been on a handful that are email
based where you just email the site all the information you tell them what you
need they email it back so some sponsors don't even want to pay for the the time
it takes to do calls so they'd rather do emails
preferably I prefer doing the calls because it provides a lot more structure
but the emails are okay too because I mean you would through email you can
only get put so much interaction with the person but over the phone calls a
lot more interaction so I prefer that that's just my personal opinion so all
this goes into remote monitoring you know you use your tools at your disposal
at your disposal your phone and your email to collect these documents
interact with the site let them know what's going on and that's why it's so
important for one that you can type correctly and efficiently in your
professionalism is on point because you're gonna be doing a lot of
interaction with the sites and a lot of interaction with all these different
groups vendors the project team the clinical team your CRA this study
coordinator sometimes the P I so you got to make sure that you are well-versed in
your communication and you're on point there so that's remote monitoring I
broke it down a little bit there in another video we're gonna do we're going
to talk about all the things that go on that you talk about during a remote
monitoring call so we're gonna go a little bit further in there and you know
we touched on it briefly but we're gonna go really in
depth onto everything that is asked during a remote monitoring call and if I
ever have to do one we're gonna go we're gonna go over that one too what I
typically ask and some of the questions I ask and you'll see the more you do the
remote monitoring calls the better you'll get at them and that's the same
thing with anything in clinical research anything in life pretty much the more
practice you have the better you're gonna be at it so that's it for this
video guys liked it like it if you liked it share it if you would like to share
it but definitely hit that subscribe button if you're listening right now
just go right on down hit that red subscribe button it's right there
so simple alright guys take care