Hello everyone. Thank you for your patience
and welcome to the Webinar titled: “Optimizing Siebel CTMS with Electronic Trip Reports”,
presented by Perficient’s Param Singh, director of clinical trial management solutions.
My name is Eugene Sefanov. I am the marketing manager for Perficient’s Life Science Practice,
and before I turn it over to Param, I’d like to go over some housekeeping items.
During the presentation all participants will be in listen-only mode. However, you may submit
questions to the speaker at any time today by typing them in the chat feature located
on the left side of your screen. Please state your questions clearly and keep
in mind other Webinar participants will not see your questions or comments. And then lastly
your questions to the speaker will be addressed as time allows towards the end of the presentation.
If you still have unanswered questions after the Webinar, or if you’d like to request
information about our services, feel free to use the contact information on the various
slides throughout the presentation. You can also fill out the contact form on the Life
Sciences section of Perficient’s website. Please note that today’s Webinar is being
recorded and will be sent to within several days. A link to the PDF version of the presentation
will also be included. This concludes our housekeeping items and
I would now like to turn the call over to Param Singh. I turn it over to Param.
Thank you, Eugene. Hello everyone! I’d like to welcome you to today’s Perficient Life
Sciences CTMS Webinar. Today we’re going to be discussing how to optimize your Siebel
CTMS application with a fully electronic trip report. So this Webinar is really designed
to explore the various benefits of utilizing a CTMS system with an electronic trip report,
including a fully 21 CFR Part 11 compliance, an e-signature feature that can optimize your
trip report for review and approval process. So, let me start by introducing myself. My
name is Param Singh and I am the director of the clinical trial management solution
practice within Perficient’s Life science business unit. I’ve been working within
the industry since 1999, and during that time I almost exclusively worked with the Siebel
clinical product. I’ve been with Perficient’s Life Sciences
business unit for over six years, including my time at BioPharm prior to the Perficient.
And before that I was part of the Extensions Farmer R&D practice and leading Siebel CTMS
implementations there, as well. So, overall I’ve been part of over 30 implementations
of Siebel CTMS, and they vary from implementations from Pharma, CROs, medical device and academic
institutions; and they vary from anywhere from 30 users or actually even smaller
than that to global implementations of 45,000 users. So, each type and size of these
organizations I implement these systems have their own approach in implementing this solution.
So, let me start with an introduction to our company. To those of you who might not know,
Perficient is a large global information technology consulting organization. Actually, we serve
clients mainly throughout North America and Europe and really our strategy and goal is
to help provide business in technology solutions for companies to be able to be more efficient
in what they do on a daily basis. One of our primary goals is to work with you
not only to deliver solutions, but also, really, to become a partner! We don’t necessarily
want to implement a solution and then walk away; we want to continue to be there to provide
solutions for you that help you meet your business needs.
So, Perficient was founded in 1997 and you’ll see that we have many offices throughout the
US We also have some global offshore resources in different countries, as well. We have a
sizable workforce, in which resources are aligned to specific technologies or industries,
and have established themselves as respective thought leaders in their area of their expertise.
As you can see here, repeat business is one of the main things that we like to try for,
because we want to build those partnerships with organizations. And this slide here just
shows some of the areas of focus that we have across our global consulting organization,
where we bring expertise around the various business solutions and technology solutions
that we bring to our clients. So, a little bit about the Life Science Business
Unit at Perficient. A lot of you probably already know the name BioPharm systems and
you’ve heard it for years in the Life Sciences space. We were acquired by Perficient on April
1st of this year and now we are the Life Science Business Unit within the Perficient Industry
Groups. Our team of experts has remained completely intact since the acquisition, so our services
and our offerings are still the same across the Life Sciences arena. We still have four
distinct practices or focus areas within our Business Unit.
I lead the clinical trial management solution practice, where we focus on CTMS and our ASCEND
accelerator solution and also Mobile CRA. We also have the clinical data management
practice, the clinical safety and pharmacovigilance and clinical data warehouse practices, as
well. They focus on their own set of products, applications, services and offerings. So,
with each of our practices, we offer the same level of industry and technology expertise,
as we always have, in implementing and hosting the various applications that we’ve supported.
And I’d like to wrap up the introductions just by taking a minute about the CTMS practice
and explain a little bit more what we do. We provide a variety of services and products
related to CTMS; we manage implementations of Siebel clinical, whether those are custom
implementations or implementations of our Siebel Clinical Accelerator, ASCEND. Also,
if you’ve seen some of our previous Webinars, you know that we do extensive work with integrations
in and out of Siebel CTMS and related systems. Our approach to implementation is very process-focused.
We also provide our process consulting services to help organizations define and harmonize
their SOPs and business processes across their organizations with respect to clinical trial
management. We also offer comprehensive training services and products related to Siebel Clinical
and our ASCEND solution. So, that’s just a glimpse of some of the services and products
that we offer in the space. Again, for more information, please feel free to visit our
website or contact us directly. So, with that wrapping up our introduction,
I’d like to go over today’s agenda. We’re going to start with a brief look at the components
of a typical size visit report, which we call “trip reports” (this is the terminology
within Siebel. Then we’ll look at four common challenges associated with completing trip
reports electronically. And then for each of those challenges we’re going to discuss
some of the ways in which Siebel Clinical– Either Vanilla, out of the box, or our ASCEND
Accelerator version of Siebel Clinical, how those systems and those configurations address
some of the challenges that we’ll go over. And then the majority, I think, of today’s
Webinar we’re going to go into a live demonstration of some of those features and completing and
approving that electronic trip report in our ASCEND Accelerator configuration, which will
include the electronic signature capability for submission and approval of the trip report.
So, we’re actually going to go into a live demonstration of the system and, again, we’re
going to be looking at the latest version of Siebel and with our ASCEND Accelerator
configurations on top of that. So, before we get started, I did want to point
out (and just remind everyone) that if you have an issue, please just use the chat feature
to bring that to our attention. And also, if you have any questions along the way that
you’d like us to address at the Q&A session after our demonstration, please also submit
those in the chat function (or the chat window) on your screen, at any time during the presentation.
Those questions will come directly to me and I can answer them at the end. Also, I want
to remind everyone that we are recording the presentation and we’re going to post it
on the website afterwards. So, with that we’ll get started.
The first thing we’re going to go over is just a typical trip report components. In
your organization you may have sort of different types of trip reports that are set up, but
what I wanted to go over is typically what we’ve seen in implementing CTMS, what are
some of the typical components of the trip reports, that we’ve seen in our experience!
So, at the right top we have our site visit information, high level information about
the site visit itself (when it was started, when it was completed, what the status was),
some basic information about the site visit itself. And then we have our checklist items,
a list of items that are typically in micro-monitoring, SOP for example, that you’ll have the monitors
to check off these things that occur during the site visit. We have our narrative questions,
questions that require some sort of narrative response. Then we have our follow-up items,
so, any sort of option items that have come out of that site visit, or open items that
again followed up during that site visit. These four pieces are typically part of any
trip report, whether it’s initiation, qualification, monitoring, or closeout.
The next piece is the additional pieces for monitoring visits you’ll have things like
enrollment statistics, so, current moment statistics on the site. Potentially, you’ll
have serious adverse events that you’re monitoring, protocol deviations, and monitored
case report forms. Those pieces technically come in a play when we actually start the
monitoring after you’ve started rolling a patient study.
So, let’s look at each of these in a little bit more detail. For site visit information
these are basic facts that you need to capture in each trip report: the back-round details
about the site visits, high level information about the sites, the type of visit the visit,
the start and ending, the status is actually prizing at that visit. This is just the high
level information about the actual site visit. So, the next is the checklist items. These
are checks that need to be done or checks during the visit that can typically be answered
with a “yes”, or “no”, or “not applicable”, so, really just going through a checklist
of things that were done and making sure that everything was addressed.
Some of the examples here of the checklist items are whether the site staff records are
current, the site regulatory binder is complete and each informed consent is countersigned
and dated. So, really, just going through a checklist of exactly what they need to do
on that monitoring visit and marking it in that checklist item. As part of what we’re
talking about are either on paper or electronically, a checklist also might have some additional
comments that are wanted. So, if you’re going through and saying “yes” to each
of those items and you come across a “no”, your business process can dictate if I
select “no” that this was not done; that the monitor requires some sort of comments;
that you can systematically do that, as well, through some configuration in the system,
but your business process can dictate that as well.
And then there are open-ended questions. Those questions are items that are required to be
done or performed during a site visit, but that requires sort of a narrative response
beyond the simple “yes” or “no”. Here are some examples of open-ended questions
of: “How would you describe the site’s compliance with the informed consent policy?”
“How would you describe the site compliance with the drug accountability procedure?”
So, it really requires some detailed assessment against each of those questions, so, it’s
not simply just a “yes” or “no”. Next we have our follow-up items. These are
the options that a site must – usually you find them during the site visits, but not
always. You can also identify follow-up items even over the phone or prior to a site visit,
but essentially it’s something that we want to be able to track, that requires some sort
of follow-up on the site and we’re going to keep some rolling over on each subsequent
site visit, to be able to make sure that those items are then complete.
Some examples are if Sub I requires training and product handling. So, if there’s some
staff training that needs to be done that hasn’t been completed yet, we would mark
that as a follow up item. Then on the next site visit, we would confirm that those things
have been completed. You can read some of the other examples here, but really it’s
just to track action item that have been either identified or continue to be monitored on
these site visits. Additionally, for monitoring visits potentially
you’re going to need to track these additional items, so, enrollment statistics of how many
subjects are screened, how many are active, how many are currently terminated at the time
of that site visit; what is the current state of that site.
You, potentially, are going to be tracking serious adverse events at the time of the
visit and protocol deviations what is our running log of protocol deviations or
violations that are occurring on the site. And then the case report forms that are being
monitored during that visit, as well. Again, not all of these may apply to every organization,
but these are typically what we see being tracked on trip reports from a monitoring
perspective. What are some of the challenges that we see
with trip reports, specifically when we’re talking about trip reports within the system,
right? The first one is adhered to site visit SOPs. How do we insure within the system — If
we have a specific monitoring SOPs established in our organization, how do we have everyone
adhere to that and ensure that they’re in compliance with those SOPs. And if they’re
not, how do we identify where they went out of compliance? Capture a snapshot in time
for when the site visit occurs. When we’re talking about electronic trip
reports, we’re talking about pulling data from what’s being tracked for that particular
site. So, how do we insure when we’re talking about a trip report that we can
actually take a snapshot in time for things like enrollment and follow-up issues and other
items, so we can look back at that electronic record month from now and see that as of July
30th this was what the state of the site was in terms of enrollment, in terms of deviations,
SOPs etc? How do we track the report during the review or approval process? Can we essentially
do a full review and approval submission directly in the system? And then how do we record compliant
approval? So, having that review process and facilitating communication back and forth
and then ultimately reporting the actual approving and signatures electronically. So, those are
some of the challenges that our clients have been met with and we’ve been there when
we were talking about the fully electronic realization of this entire process. So, how
do we address some of those challenges? So, the first one: adhering to SOPs. Siebel
Clinical addresses the challenge of adhering trip reports adhere to governing SOPs through
a template functionality. So, a template is essentially like an outline that allows you
to create a sort of blank form that monitors can fill out each time they visit a site.
It’s almost like enabling and embedding your SOPs, your full template of items that
need to happen on every trip report when monitoring a trip report.
All of that can be enabled as a template, so when you create a new monitoring report
the template will mirror that SOP and apply it to each trip report, so then the monitor
can actually go in electronically and mark off the checklist. This functionality really
ensures that you can adhere to those SOPs and consistently do monitoring in a standard
manner. The great thing about that is the templates are also administered in the system,
so, as your SOPs change, you’re not actually having to change your process; or as your
organization grows and you have a different monitoring process in a different geography,
for example, all that you would need to do is to create a template to that geography.
It gives you a lot of flexibility in that it’s driven by an administrative feature,
but also ensures compliance across your operating procedures.
So, to demonstrate how a trip report template can be set up to mirror SOP, here’s a portion
of a sample monitoring visit SOP. This shows two sections: one about regulatory binders
and one about a study product. Let’s see what these items look like in a trip report
template. In this example, each of the lines from that SOP that we looked at earlier related
to regulatory binders, have been converted into your checklist items. They can be answered
with “yes”, “no”, or “not applicable”, or some sort of dropdown. And the section
of the SOP that was about the study product has been converted into open-ended questions.
So, you can see the questions that we looked at: “How would you describe the storage
space and the condition of the study product? Adequate? Secure?” That’s an open-ended
question, so, that’s actually a question and not a checklist item.
This is how the Siebel application can actually convert directly from your SOPs into these
specific templates. So, once that template is in the system, this can apply multiple
times to every site visit that’s needed to be filled out from a monitoring perspective.
During the demo, we’ll actually look at some of that and how to use that template
to complete the trip report. So, we’re going to actually look at that and we’ll look
at one particular example of how do we translate that and how we help our clients translate
their SOPs directly into these templates. Another common challenge associated with trip
report is they needed to have the report reflect a snapshot in time. This is easy to do with
paper reports, because you’re filling out the paper once and you’re submitting it
essentially. But it becomes a lot trickier with electronic reports, because you’re
using data that are constantly being updated. So, your enrollment, statistics is being updated.
How do we take a snapshot to be included in our trip reports? You need to record and track
even the statuses, follow-up items, or protocol deviations without needing to recreate them
for each new trip report. In ASCEND, in our Accelerator, we’ve created
these areas outside of the trip report, where you can track things like follow-up items,
protocol deviations, SAEs, CRF monitoring, and then within the trip report there’s
a way to actually import the read-only copies of those records. Again, we’re going to
look at how that’s going to work directly in our demo, but essentially what’s needed
to happen is we need to pull in and make copies of the records and copies of enrollment statistics
and then embed them directly in the trip report, so they remain static while the rest of the
data that you’re tracking actually continues to be updated. We’ll show you exactly how
that works in just a couple of minutes in our demo.
Another common challenge is they needed to track the trip report as it moves through
its review process. With paper reports it’s easy to walk the report around from desk to
desk, but we need to configure the systems so it can actually do that electronically.
So, if we have an electronic trip report, we need to figure out a workflow that’s
going to facilitate that communication back and forth that review that review process
back and forth between the submitter and the reviewer. So, one of the things that Siebel
CTMS has out of box is this trip report “Status” field, which is governed by a state model,
so it controls the order of status changes and which user can make which changes in the
system. You can actually dictate based on different users, different user types, who
can actually the status from trip report in progress to submitting, versus submitting
to be rejected or approved. The Siebel system out of the box does that.
In our Accelerator, ASCEND, we’ve sort of taken that process a little further and put
in a full electronic signature capabilities with re-authentications. Every time that you
submit a trip report or approve a trip report, we want to capture an electronic signature
so we re-authenticate the user. We also have a complete visible audit trail, so when we
submit, reject, all the different types of status changes that happen, any number of
rejections that may have occurred, all of those we capture in the visible audit trail.
That’s something that, again, we’ll look at in a couple of minutes, but essentially
the Siebel application allows us to have that complete back and forth review directly in
the system. So, there’s no need to print out an actual report or email an actual report
and do that review process. You can actually do it directly in the system as well.
And last is the biggest challenge, because it’s related to that review process. The
biggest challenge that we’ve seen when it comes to electronic trip reports is how to
ensure approval of those trip reports. There’s three primary ways of approving
a trip report, each with varying degrees of compliance. The first one, which is the most
I guess conservative, is ink signature. So, while you can still do the review and
approval of a review process and finalize that trip report directly in the system, some
organizations choose to go down the very conservative route where we still need to print that report
once it’s final and then having ink signatures on those printed reports and then file them
away. The next conservative is the full on re-authentication of the users, so, capturing
a fully re-authenticated electronic signature upon submission and approval in the system
and having that in an audit trail as well. That’s something that we’re going to look
at. That’s what we’ve built our ASCEND Accelerator on. And the last one is the visible
audit trail. It’s still following that same review and approval process, but the only
thing it doesn’t have is that re-authentication pieces (you know, the user having to log in
username and password each time that they’re actually filing the document), but we’re
still controlling who gets to change the status from submitting to be approved within the
system controls and we’re capturing that visible audit trail. So, those two are similar
in nature. The re-authentication method, of course, captures the username and password,
so, each time it ensures that the correct user is essentially signing the trip report.
In the demo we’re going to show you that a full re-authentication piece with a full
electronic signature piece around the submission and approval of the trip report.
That’s all the slides that we have around today looking at this whole electronic trip
report topic, so, we’re going to go into the demo. We’re going to spend a descent
amount in the demo, just to go through all of what we’ve covered around what the system
can do for us. So, let me share my desktop here. What we’re going to go through essentially,
is creating a new trip report; going through the actions of completing it; going through
the actions of submitting it; and then, I’ll log out of the system and log back in as a
different user and approve or reject the trip report. We’ll sort of go back and forth
just a little bit, to sort of facilitating that review and approval process, and how
that’s going to work. So, let’s jump into site management. And
again, for those of you that are not familiar with the latest version of Siebel this is
what we’re looking at right now. It’s the latest version of the Siebel Clinical
application with our ASCEND configuration on top of it. So, those of you that have seen
Siebel Clinical out of the box, what you’re going to see today are some of the features
that are a little bit different, since we’ve enhanced our system in our Accelerator. I’m
just going to go into one of our sites here. Before we go into our actual trip report,
I want to show you how we’re tracking the information that’s actually going to be
fed into our monitoring trip report. The first piece that we’re going to look at is we’re
going to follow-up items first. So, we mentioned that follow-up items is a typical inclusion
into our trip report. What we have here is a running list of follow-up issues that we’ve
tracked for this particular site. You can see that some of them are open…Some of them
are closed…We have a different categorization available, so, you can have different follow-up
issues and you can categorize them in a different way whether it is documentation issue,
training issue, personnel, facility etc. So, you’re actually putting in these issues,
you’re putting in a status, so, (if it’s open), you can see: when they’re open; when
they’re closed; due date; completed date; who it’s assigned to… And then we also
have this checkbox of selected for trip report. Now, by default we’ll see this when
we going to into the trip report, but by default all open items — If an item is opened
today on this site visit and it remains open during the next two site visits, that item
is always going to be pulled in automatically into the trip report. So, we have this feature
to sort of carry over where that issue will carry over from each site visit report to
the next. When you close that trip report to include it — Let’s say I closed a particular
follow-up issue today… Once I mark it as closed, I would select the trip report. So,
any closed items that are closed, within the last site visit for example, and we want to
include it within this site visit report, we’ve selected for the trip report and then
ultimately it will get pulled in. Let’s look at protocol deviations. So, we
had the follow-up items and now we’re looking at protocol deviations and this is a way for
us to track our protocol deviations. So, again, we have a type of protocol deviations, whether
it’s con meds, eligibility, informed consent, visit window, study device/drug deviation;
different basic categorizations of deviations or violation that are potentially occurring
at that particular site. You can put in a description in a current state identified
by monitored subject statistics. Deviation or violation like a visit window violation,
you can actually select and associate it to a particular subject and put it the options
required of resolution if we have those details for this particular deviation.
Next we’ll look at the adverse event. So, here we have a listing of adverse events or
serious adverse events that were monitoring that were sort of managing at a site
level, whether they’re adverse events or serious adverse events. We can associate them
to a subject; we can put in an event name and then just high level information about
that particular adverse event just from a monitoring perspective, right? It’s not
meant to be a safety system, or just sort of capturing high level details about the
adverse events that we’re monitoring for this particular site.
The last thing that we’ll look at is CRF tracking. So, here we have a listing of all
of our planned visits, planned number of CRF pages, and then I’m going to use them in
the system, during each of the CRF page details (which pages we’ve collected, which ones
we’re missing, which one’s are verified, what’s retrieved, and any additional comments).
So, with each of these things that we’ve looked at outside of follow-up tracking, CRF
tracking, protocol deviations, adverse events… Those can come into the system automatically
through and EDC or a Data Management Integration, as well. You basically see the setup in the
system where you can actually this information outside of the trip report. Typically in Vanilla
implementations of Siebel Clinical, and others, we see some of this information sort of embedded
directly in the trip report and that’s the only place to see that (like follow-up items,
for example). What we’ve done differently is we have all of those pieces as part of
the site management you know, follow-up issues, CRF tracking, adverse events, protocol
deviations but it’s also going to be a component in our actual site visit report.
We’re going to manage these sort of living records and we’re going to continue to manage
an update, versus in the rip report they’re going to be static records.
Now I’m going to go into my site visit area and, what I’m going to do, is actually create
a brand new site visit report. And I’m going to make it a site monitoring visit and all
of those components are going to be adherently a part of the site monitoring visit, where
they wouldn’t necessarily be a part of that in an initiation or qualification visit. So,
I’m going to go into the client visit hyperlink here and it’s going to give me a blank canvas
for my actual electronic trip report the fully electronic trip report that’s in the
system and we’re going to go through the options of creating it. I’m going to
put in our site visit details you know, the highest components that we talked about!
Let’s say the visit started today and it ended today (so, it’s a single day visit).
As soon as I enter that information, you’ll notice that our current enrollment statistics
are blank right now, but as soon as I enter this date the system is automatically going
to calculate and take a snapshot of our current enrollment statistics of subjects across each
of these statuses. Or how many do we have screened, enrolled, total completed, active,
early terminated and etc. This is a snapshot that’s happening as soon as that visit is
completed and comes in. Even six months from now when we’ve enrolled many, many, many
more patients, if I come back in this electronic record, it will show me that as of July 31st
2014 we only had: 21 enrolled, 8 completed, 9 active etc.
Next I’m going to actually show you what the template functionality looks like. We’re
going to apply embedded SOP, monitoring SOP, in the form of a template. So, I’m going
to lock at this demo site monitoring template and click “ok”, and this is going to apply
all of our checklist items directly to the system! And our questions as well! So, these
areas were blank when we came in here, and now it has all of our questions and checklist
items directly in the application. Now it’s where the SOP comes in. It takes
the guesswork out of what I need to do, just by applying that template. I’m just going
to go through the notion of putting in our answers for each of these questions here.
I can type them in, I can choose from the dropdown and I’m just go through that
really quickly here and the last question here– So, you can have a process like I said.
If anything you’ve answered as “no”, we’re going to put in some additional comment.
So, you go through that and then, down here, these are the narrative questions. This one,
I’m going to put in a narrative response, as it requires additional details. I’m just
going to say that the storage is adequate. The next piece I come on to is our monitoring
follow-up items. Everything is blank here. All I simply have to do is I already managed
the site, so I just input everything that’s relevant. It’s going to pull in everything
that’s still open. So, anything that’s not closed essentially will be pulled in here.
These are all read-only! I can’t edit this information, but it’s telling me what’s
currently going on at the site: what are the open items at the site and what has been closed
since the last site visit! Those are the ones that I selected for the trip report and automatically
they get pulled in. I’m going to input CRF. I just click on that button and it will pull
in all of the ones that I’ve selected for the trip report so, everything that I’ve
monitored. Protocol deviation is going to pull in all of our running lists of accumulative
protocol deviations at the site. And then SAEs… If you remember, we had two SAEs and
one AE, so, this is designed to just pull in our serious adverse events. Both of those
came in. Now I’m ready to submit the trip report. You’ll notice that I have a submit
button here, but before I can do that, I actually have to assign a reviewer to the trip report.
So, I have to define who is assigned to this trip report, or who is responsible for this
one, and then who is actually going to be the reviewer.
Before I can submit it, I have to have a reviewer. I’m going to pick somebody other than myself.
If I choose myself, it’s not going to let me submit a trip report directly to myself.
So, now I can submit it and this where the electronic signature comes in to play. “Are
you sure you want to submit this trip report?” I say “yes” and then it gives me some
sort of legal warning around: “this is the equivalent of physically signing this document”,
and I say “ok”. Now I will enter my username and password
and if I don’t ensure the correct password, it’s not going to let me… So, I’m going
to enter that in, it’s going to automatically flip the trip report status to “submitted”
and put in the submitted date. So, I can’t approve my trip report, because I’m not
listed as a reviewer. And even if I were, I wouldn’t be able to approve my own submitted
trip report. So, there’s some logic in place here that doesn’t allow you to review and
approve your own trip report. I’m just going to log out really quick and
we’ll log in as the reviewer. On the homepage we have this concept of an inbox. So, here
we have basically notifications. Anytime somebody submits a trip report, or approves a trip
report, or rejects a trip report, that’s where you have an option pending. It’s going
to show up on your inbox. Now I submitted it to this admin and now they
get a notification in their inbox. I’m going to click on that notification and it takes
me directly to the trip report in question. I, as an administrator or a reviewer, can
now go through and review this trip report. And you’ll notice that the import buttons
are turned off. So, once it’s submitted everything is in a sort of static mode. The
only thing that I can do is put in a reviewer comment against things that I want updated.
So, for example, if
I wanted some additional comments here and say “This is not filled out! Complete this!”,
I can put in a comment directly on the checklist items or questions. And then if I want some
reviewer comments on the entire trip report itself…
So, for example, I notice that here in the question it says storage is adequate, but
in my follow-up items I see that there’s an open follow-up item saying the supplies
are not kept in a proper facility. So, that conflicts with the checklist items. I can
put in some reviewer comment and say: “Close appropriate follow-up issues”. I can reject
this trip report. For rejection it just gives me the warning;
it doesn’t require me to sign the trip report. So, that signature is only required during
an approval. Now, if I log out and come back in as myself, I should see a notification
potentially of that this trip report was rejected. I can go in and actually make those updates.
So, here I see that the Siebel administrator has rejected my trip report. It’s telling
me to rectify it. I can click on it and I’ll go into the trip report and make an update
if needed. For updating this information I can obviously update directly on the checklist
items in the question. If this needs to be filled out, I’ll just
fill that out directly; put the reviewer comment (“close appropriate follow-up issues”).
These, like I mentioned, are read-only right now, because they’re snapshots and I can’t
really do anything here. What I have to do is go to my site and update the management
information for that site. So, I’ll go into my follow-up issues for this, I’m going
to look at this and close that issue, I’m going to select the trip report and then put
in some additional comments. So, now if I go back into my site visit and if you look
at this follow-up items section, you’ll notice that that record is still saying “open”
and there’s no comment. So, the updates that I made are not in this record, because
this was a snapshot that was taken when I submitted the trip report. So, if I want to
update this information, all I simply have to do is import.
You’ll notice that now it shows “closed” and there’s my updated comment. So, that’s
really to show you that this is truly a snapshot in time. So, that if I come back a year from
now, it’s going to show me exactly what the status was of that site at the time of
this particular site visit, once it gets finalized. Again, I can submit those trip reports and
go to those options. What I also want to show you in the demo at
this point this status audit trail. So, there’s a full on approval history, so, when I look
at this particular trip report, I can see a full status history of this particular trip
report. When I submitted it, when it was rejected,
it was projected by and then finally it was resubmitted. If you have multiple iterations
of submission-rejection, you can actually dive into approval history to see why it took
so long for that trip report to get approved. So, there’s a lot of adherent features in
the trip report that show your progress in the organization against your metrics around
monitoring, your metrics around trip report, review and approval to the point where you’re
actually seeing how many days of trip report for turn around. So, all of that has been
dealt into the trip report functionality of our accelerator to help an organization drive
those metrics and do that full review and approval directly in the system, without needing
to print the actual report. And what the report looks like, actually, I just have it open
here… Once it gets finalized and approved, you need
to potentially generate a PDF and this is just a sample of your enrollment statistics,
your list of attendees, your checklist questions. You’ll notice that the comments are in here,
but not the reviewer comment; your approval history; the approval signature section this
is still in here, but you can actually remove it and have the system generate an equivalent
of the electronic signature directly here, based on the electronic signature that’s
in the system. And then it has all of your monitoring license, as well. Your follow-up
issues, your monitoring CRF, your protocol deviations log and your serious adverse events.
This is what the trip report prints out on the PDF, once it’s finalized, can look like.
With that, I will end the demo and I will open it up I think we have a few minutes
here for some question and answer. So, Eugene, I’ll turn it over to you to moderate
them. Great, thank you! So, before we begin to reach
out to the questions, I just want to remind everybody that you can ask your questions
in the chat feature on the left hand-side. And we’ll go through as many as we can get
to! We have some questions that already came in. I’ll start with the first one: “Are
the adverse events sent from EDC or are they captured here in this application?”
Great question! For things like subject enrollment statistics, subject, subject visit, completion,
CRF, serious adverse events, protocol deviations, all of these pieces in the live demo today
they were entered in the system manually. But each of those items that I just mentioned
all of those objects! are just as easily being able to be captured from and
EDC system or a data management system. It really depends on how this system is set up,
to be able to extract that information in sort of a standard manner across studies from
those systems, so, we’ve been able to do it. For example, Oracle Clinical and RDC,
we’ve been able to do that and capture all of that information automatically and send
that information into Siebel Clinical. So, once that information is there (when you’re
talking about completing your trip report, you’re importing that information that was
automatically sent through that integration. So, all that is possible, but it’s also
possible to just enter that information directly into Siebel. So, it’s really up to you,
whether you have a capability of interfacing to your EDC system, whether you have one system
that is multiple that can increase the complexity a little bit, but ideally you have that information
automatically entered from a source system, rather than manually entering them.
Great! The next question is: “Are there versions available to be used on iPad or MAC?”
Yes, for the latest version of Siebel Clinical. So, whether you’re talking about a Vanilla
implementation of Siebel Clinical 8.1, 8.1.11, which is the new Open UI version of Siebel
Clinical. What Open UI really means is, it’s a browser
agnostic, and it’s system and device agnostic. You can run the entire application as you
saw it today on any browser with any sort of Windows machines (like Chrome, Firefox,
IE 10+). You can also run the entire system on an iPhone, on an iPad, on your MAC, on
Safari… So the sort answer is yes! The system that you saw today all of its
functionalities and all of the capabilities can be run on any version of Apple devices,
Android devices, as well as Windows machines. So, as if anything is zero installed and you’re
just using a browser to access the entire application.
Okay, great! Thank you. This actually ends our Q&A session. We didn’t have any more
questions, so, we’re actually right on time! We’d like to thank you very much for joining
today’s Webinar. As a reminder, the recording will be sent
to you within the next few days for you to share with your colleagues. We have several
upcoming Webinars that you are welcome to register for. You can visit Perficient’s
website and view the upcoming ones that we have. If there are additional questions, feel
free to email. You can see the contact information on the screen right now.
We thank you very much for your participation and hope that the information that we provided
you would say it was helpful. Have a great rest of the day and evening.