hey guys Serg back with another video today we're gonna go in depth down deep
into an annotated report stay tuned
hey guys easy RG here back with another video today we're gonna be talking about
what isn't annotated report what exactly is on an annotated report because I know
how loud you guys are curious now if you haven't watched my last video about what
is an annotated report I would go and watch that because that really sets the
foundation for today's video about you know what exactly the questions that are
on an annotated report so just quick summary annotated report is basically a
template for all the things that should be looked at on a monitoring visit now
like I said before go and look at the previous video the title of what is an
annotated report and to learn a bit more about exactly what what that template
entails but you know now we're gonna go deep so the first thing that's typically
on an annotated report that they want to talk about or that the study team wants
you to talk about on a monitoring visit is subject recruitment subject
recruitment is huge subject recruitment is one of the most important things that
allow site to be selected for study so obviously from the CRO and the sponsors
perspective we want to know how are you doing with recruitment so on the
annotated report is just going to be a template but what I typically do is I
look at the SIV report or the P I questionnaire or
feasibility survey and look at how many patients this set the site said they'll
be able to enroll and I write that down on my annotated report so if the sub if
a site says they're gonna enroll ten patients I write that down there so I
know that what I'm talking to the study coordinator either on the phone or you
know on site I know hey they said they're gonna enroll this many patients
so that's typically how I start and I typically open up with a very open
question about that you know how is recruitment going and I look let them
talk typically you don't want to put words in the site's mouth when you're
talking about recruitment you want to let them you know kind of tell it from
their perspective and then you can ask follow-up questions from there so you
know on the on the annotated report they're just gonna be a general question
that that will say something like you know is
the site on target to meet the enrollment plan for this study if no
then refer to action items so that's that I typically add a lot of follow-up
questions to my my personal annotated report but on the annotated report
itself is just gonna have that very general question so okay yeah next on
the annotated report is gonna be a section about informed consent and now
this is just one version of an annotated report I'm sure other ones may be
structured differently depending on where you work but you know this is just
one version that are out there out of probably many but they're all gonna be
you know structured in a particular way that makes sense for that CRO or for
that sponsor so you know one of the sections that's also on there is
informed consents so it'll be like you know is in for information regarding
informed consent being collected for this report an informed consent is very
important to the study because that's where the study coordinator where the PI
is going to educate each patient about what is going on in the study and
usually for informed consent if it's if it's a pediatric study there's gonna be
a sent forms which shows that you know they sign off on it but there's also
gonna be consent forms which show that you know the parent signs off on it too
so you're gonna need both but if someone's over the age of 18 then all
they need is the consent so you know typically you have to collect the
information that's on the informed consent form like version date a
signature date things like that so next section is going to be dealing with
informed consent then the section after that typically there's gonna be a
section about queries and action items so typically that you know they're gonna
ask the generic question is is the site current with data entry and query
resolution and this is the section where you know you they talk about the queries
you talk about the queries and you know any missing data points and you know
we'll do a further in-depth video on you know some
of the follow-up questions but really I just wanted this video to be about the
generic annotated report template so you guys have an idea of what that's like
and then then there might be another question that says where the previous
action items and data queries resolved you know on the annotated report it's
really just a guideline in a template so typically when you're in the system and
the CTMS system there's gonna be you know checkboxes for the annotated report
saying yes or no so if you noticed that previous question you know where
previously opened action items and queries resolved that's a yes or no
question so if they were resolved you check yes if they were not resolved you
check no and all of these tend to be yes or no questions and then you know and
the next section is gonna be are there any protocol deviations to report that's
a yes or no question if yes and then you're gonna want to
describe them a little bit further in the next box but that open question is
just a yes or no question okay and then another box is going to be about any
serious adverse events so did this the staff report or did the site report any
serious adverse events that's a yes or no question
and then they typically ask about other serious adverse events so they say have
there been any serious adverse events previously and that's a yes or no
question also so you're getting you're beginning to see a pattern here about
the yes or no question on the annotated report and then they you know they ask
other questions next the next was gonna be a whole section about the
investigational product so they're gonna ask you know has the randomization
process been followed according to the protocol so yes or no question
has the blind been maintained if there is a blind that is so they're gonna ask
about that that's a yes or no question is there enough and I pee without
expiring is there enough unexpired I be on site that's a yes or no question
and like I said if there's a there's a follow-up to that if the site will
usually say yeah but you know it's expiring next week so then you've got a
you know tell them to order a new IP
like I said uh you know we'll the blind maintain question is really a yes or no
there's not really gonna be any follow-up there then you may ask you
know next question is gonna be about clinical supplies in the facilities if
they're if there are any changes there so you they might ask you know are there
enough clinical and lab supplies that are not expired also so that's a yes or
no question and you might ask you know how are the
how are the equipment at the facility are they being properly maintained and
calibrated and that's a yes or no question also but you know a follow-up
question to that could be when was the equipment last calibrated and what is
the calibration schedule like now this is a question that you would typically
ask in the earlier stages typically after you've done like a bunch of
monitoring visits or monitoring calls you don't need to ask that question
anymore because I already told you what the schedule is like some of them you
know they do it every six months some sites do it every month it just depends
on the site and then another question might ask are are the biological samples
being adequately collected for the study labeled stored packaged all that stuff
and that's a yes or no question also but this this is going to be different per
annotated report not all not not everything you know may be shipped on a
weekly basis or something like that some of the samples may be held for months at
a time some of the samples may be shipped every day
it just depends so the annotated report is going to be different per protocol I
cannot stress that enough this is a living this is going to be different for
every study that you're on so you know some of the questions are
gonna be generic and they may be you know per protocol per per study per
protocol but there are gonna be different different ones you know but
here's one that's gonna be you know the same for every study they ask about the
site qualifications you know have the site staff remain the same since the
last visit they want to make sure of that because you want to make sure if
there's a new study coordinator coming on that you have their medical license
their financial disclosure form there's the updated 1572 new GCP
training new protocol training that's why you want to make sure that you ask
these questions but a lot of times you know if you're doing these monthly or
every other month there's no new site staff changes typically but when there
are you wanna make sure you ask that question so you can get all the stuff
into the TMF and then you also ask you know has all site staff and adequately
trained up into this point so those are just the simple generic questions and
that's gonna be on every study pretty much yeah that's unanimous
then you may ask off the TMF now it's the monitors job to review the TMF and
collect any outstanding documents sometimes they may have an in-house CRA
to help them do this sometimes they may have another monitor that's gonna help
them do this sometimes it's just themselves just depends so you know they
may ask about the TMF on the annotated report but that's really a question for
you to answer because the site is not responsible for uploading documents into
the TMF the site is responsible for providing documents to the CRA to upload
into the TMF but they are not responsible for uploading into the TMF
directly so a question may be are all essential documents present in the TMF
which can be on the annotated report and you know that's not something you would
ask the site that's something you'd ask yourself so but that's on there and then
typically at the end I mean that's the end of the of an annotated report like I
said you're gonna be gonna be some follow-up questions that
you might have in there as you get more experienced but you know the last
question you would ask is when can we schedule the next visit and you go ahead
and get a date tentatively on the calendar now if you're doing visits
every month it's gonna be a lot easier to stick to that visit but if you're
doing visits every other month or even longer than that every three months you
know things come up for the site they may have a patient coming in and have to
cancel that visit so you're gonna have to make sure that you reach out to them
a week in advance or a few days in advance to make sure that date and time
it still works same thing if you're doing remote monitoring also so you know
that's just a basic annotated report like I said each study protocol gonna be
a little bit different and they may have more information on there depending on
the study and they may have less information on there depending on the
study each CRO is gonna have some kind of template and then it's gonna be the
study team leads the project manager the lead CRA or a clinical trial lead and
then in correspondence with the sponsor to come up with the annotated report for
that particular study so that's an important distinction to make that you
know these these change based on the study and I know I've said that a bunch
but it's just very important to understand that so alright guys if you
have any questions comment down below email us elite clinical group at
gmail.com interested in the resume review program email us they're also
happy to have you and take care guys