Explaining the Different Types of Routine Monitoring Visits

Explaining the Different Types of
Routine Monitoring Visits

Introduction
In the clinical research industry, there are several types of basic monitoring visits
that everyone involved in it should differentiate, especially CRAs (monitors). A CRA
(clinical research associate) or a monitor is the person responsible for visiting a
site in order to ensure that the clinical trial is being conducted properly. The CRA’s
tasks include on-site visits and ensuring compliance, subjects’ safety, data quality
and integrity, etc. Although clinical trials belong in the medical field, a CRA doesn’t
have to be a doctor or a medical professional. It’s enough if a CRA has a
background in Life Sciences, past experience in clinical trials (most often as a
coordinator), and the proper training.
The main monitoring visits are the Site Selection Visit, Site Initiation Visit, Regular
(Interim) Monitoring Visits, Site Close-Out Visit, and the Pre-Audit Visit. Out of all
these monitoring visits, here we’ll pay more attention to the Routine Monitoring
Visits, as one of the most frequent and important visits at a site.
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Explaining the Concept of Routine Monitoring Visits
Usually, the CRO will have to prepare a
monitoring plan for each site conducting
the study, which will later be given to the
CRA as a guideline. In almost all cases,
even though a CRA might be assigned
multiple sites to visit, they will all be
conducting the same study. This is done
so that the CRA’s job is easier and he/she
is not overwhelmed with different
protocols. As a general rule of thumb, the
CRA will be appointed to geographically
close regions. However, this is not always
the case, so the CRA should be aware of
the fact that sometimes they might need
to travel for site visits.
DEFINITION
As the name itself suggests, a
Routine (or Interim) Monitoring
Visit is a mandatory and frequent
visit that occurs every 4 to 6 weeks
(sometimes less often), depending
on the site’s enrollment volume.

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Different Types of
Routine Monitoring Visits
As we’ve mentioned before, the sponsor or the CRO will have to prepare a
monitoring plan for each site conducting the study. They will do this based
on the site’s enrollment predictions and capabilities as well as on the
different risk profiles of each site. In creating this plan, the CRO/sponsor
can choose between 2 different types of Regular Monitoring Visits:
Traditional Monitoring Visits
Risk-Based Monitoring Visits
a third sub-type of visits is the Remote Monitoring which we’ll
discuss further in this article.

What is Traditional Monitoring?
Up until recently, Traditional
Monitoring was used worldwide.
Traditional Monitoring entails that
when the CRA visits a site (usually
every 4 to 6 weeks), he or she
engages in a 100% complete
Source Data Verification (also
known as SDV).
SDV entails checking if all the
reported data matches the original
documents.
With this type of monitoring, the
CRA spends all their time for SDV,
which means there’s little to no
time left for other important site
visit activities such as checking all
the regulatory documents, PI
meetings, site support regarding
recruitment, protocol training, etc.
The Traditional Monitoring
strategy is the same for every site,
regardless of their risk profile, and
the only difference you might see is
the frequency of the visits.
As expected, the more
enrollment the site has, the more
frequent the visits.
When the time comes for another
Routine Monitoring Visit, the CRA
will simply continue where he left
off with the SDV.
Traditional Monitoring Visits are
not the perfect strategy since
they disregard the site’s risk
profile and waste time on
unnecessary protocols instead of
focusing on the weak points of
that specific site.

What is Risk-Based Monitoring?
Contrary to Traditional Monitoring,
Risk-Based Monitoring takes into
consideration the so-called “risk
profile” of each specific site and
then targets the site’s weak points
instead of wasting time on
unnecessary formalities.
Ever since 2013, when the FDA first
released the guidelines for Risk-
Based Monitoring, more and more
sponsors and CROs choose to use
this strategy instead of the
traditional one.
The reason behind this is that the
Traditional Monitoring strategy
entails an unnecessary waste of
time and resources, while the Risk-
Based strategy is more focused and
targeted towards the actual
weaknesses of each individual site.
Nowadays, Risk-Based Monitoring
is seen as much more productive,
effective, and efficient than the
traditional one.
Additionally, the Risk-Based model
uses algorithms with all the data
which allows for a better detection
of problems and frauds.
By detecting issues and fraudulent
activities electronically instead of
manually, we save a lot of time
which can be dedicated to more
important activities.
This practice largely increases site
productivity.

What is Remote
Monitoring?
The concept of Remote Monitoring cannot be defined
as a third and separate strategy, but rather as an
additional one which will be used in combination
with either Traditional or Risk-Based Monitoring.
DEFINITION
Remote Monitoring is defined as a practice which
allows CRAs to perform Source Data Verification
(SDV) and view all the sources remotely – in virtual
workspaces. Usually, SDV is performed on-site,
which again can be seen as a waste of time that’s
better to be used on other improvements. For this
reason, many sponsors and CROs are starting to
incorporate Remote Monitoring as an amazing way
to increase the productivity of Routine Monitoring
Visits.

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How does the CRA prepare
for a Routine Monitoring Visit?
Before anything else happens, the CRA will be given a so-called Monitoring
Plan which will serve as a guideline for his visits.
Next, we’ll explain to you the things that a CRA must learn and know in
order to be prepared for a Routine Monitoring Visit.

After the CRA gets assigned a site to monitor, the CRO or the sponsor should establish CRA guidelines. These guidelines
will contain:
CRA Guidelines
The CRA’s internal
communication chain
The person
whom the CRA
should report to
The CRA’s
communication
with the site
The CRA’s
communication
with the
sponsor
These are the things that will be stated in the guidelines even before the study starts in order to avoid confusion and
miscommunication.

The timeline that the CRA will be given will contain information such as the frequency of site visits, which site to visit when, etc.
Usually, in traditional monitoring, you will visit sites every 4 to 6 weeks, while in risk-based monitoring the visits will be on every 6
to 12 weeks. However, this timeline also varies from site to site depending on the enrollment numbers and activities. In this
timeline, the CRA will also enter any schedule changes that might occur throughout the duration of each study. Such changes in the
schedule should always be reported to the CRO as well as the site. The communication method of scheduling and notifying all
parties should also be stated and explained in the timeline.
Monitoring Visits Timeline
Traditional Monitoring
Sites are visited every
4 to 6 weeks
“ “ Risk-Based Monitoring
Sites are visited every
6 to 12 weeks
“ “Frequency
of Visits

Being prepared for problems and adverse events is
extremely important for every CRA. You, as a CRA, will
be given some sort of a guideline that will help you
and show you how to deal with any problems that
might arise throughout the study, as well as how to
react and report when any adverse events occur.
Knowing how and when to react is important for the
safety and well-being of patients as well as the good
performance of the site. The CRA is the person who’s
basically guiding the site and making sure that it acts
in compliance.
Problems and Adverse Events

These systems are used to simplify the management of randomizing, enrolling, and dismissing subjects, as well as to
optimize the supply and stock of IP (investigational products). As a CRA who’s responsible for monitoring the whole drug
accountability and randomization process, you should be familiar with the way these systems work. In this way, you’ll be
able to better understand and follow your monitoring tasks and act when something isn’t done right.
IVRS/IWRS Knowledge
Interactive Voice Response
System
Interactive Web
Response System
IVRS IWRS

As a CRA, you’ll have to be able to understand all
things concerning the IP (investigational product)
such as IP receiving, administering, storage, IP
accountability, dosing compliance, return and
destruction of the IP, etc. Furthermore, you’ll have
to ensure that the site is properly conducting their
orders, shipment, and inventory or storage
procedures.
IP, Orders, Shipment and Inventory Knowledge

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Before, During, After...
When it comes to Routine Monitoring Visits, there are three things of utmost
importance that both sites and CRAs should be familiar with.
1. The first one is the Confirmation Letter which happens before the visit,
2. The second milestone is what happens during the visit,
3. And the third one is the Follow-Up Letter which takes place after the
visit. Below, we’ll give you a detailed explanation of these three points.

Before - Confirmation Letter
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Before each Routine Monitoring Visit,
the CRA is supposed to send a
Confirmation Letter to the site which
states the date and time of the visit.
The site should then decide if this date
and time are good for them. Aside from
this, the Confirmation Letter usually
contains also bullet points of which
activities the CRA will perform on the
following visit and which documents
will be reviewed. In this way, the site
will be able to prepare for the visit and
provide all the necessary details to the
CRA without losing valuable time.
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These activities are usually called
“action items” and they’re basically
tasks which the site needs to provide
or correct before the visit. Many
Confirmation Letters will also contain
the information of whether or not the
PI will need to be present for the visit,
and if so, then for how long. Usually,
PIs should be available for each visit
for at least 15 minutes.
Date and Time of Visit
Action Items for Review
Needed PI Time for the Visit
Documents for Reviewing
Confirmation Letter

During the Visit
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Most commonly, the site coordinator is the one who has the obligation to receive the CRA and provide him with the necessary items for the
monitoring visit. Depending on the monitoring style (traditional or risk-based), each CRA will have their own way of doing things. Usually, the
CRA will ask to review all new action items that occurred after the previous Routine Monitoring Visit. These will probably include some (or all)
of the following: Drug (IP) Accountability, EDC Source Verification, any protocol deviations, Recruitment Numbers and Plans, Training Logs,
Subject Visit Logs, Regulatory Maintenance, Informed Consent procedures, checking for problems and adverse events, meeting with the PI,
etc.
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CRC receives the CRA CRC provides the CRA with necessary itemsCRA will review all new action items
CRA tells the
site what needs to be changed or corrected

...During the Visit
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Common action items
reviewed on a visit:
- IP Accountability;
- EDC Source Verification;
- Protocol deviations;
- Recruitment numbers and plans;
- Training Logs;
- Subject Visit Logs;
- Regulatory Maintenance;
- Informed Consent Form;
- Problems and adverse events;
- PI meeting; etc

After - Follow-Up Letter
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The Follow-Up Letter is an official letter that’s sent
after the Routine Monitoring Visit.
As the name itself suggests, this letter contains a
summary or an outline of all the action items that were
reviewed during the latest visit.
Everything that needs to be resolved until the next
visit, as well as all new randomized subjects, can be
found in the Follow-Up Letter.
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Aside from all these things, this letter will also note if
the PI was available for a discussion during the visit
or not.
Irregular PI meetings and inadequate PI oversight are
two things that do not portray a good image for that
site.
To put it simply, the Follow-Up Letter should give
detailed information about everything that
happened during the latest Routine Monitoring Visit.

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CONCLUSION
Routine Monitoring Visits are definitely the most important types of visits that occur throughout the duration of a study. The CRA (the
monitor) is the person who’s supposed to keep everything in check and make sure that the site is working according to all guidelines and
safety procedures. Like this, the site will continue moving on the right track and many unnecessary compliance problems can be
avoided. In this article, we’ve explained to you the concepts of Traditional Monitoring vs Risk-Based Monitoring, as well as the idea of
Remote Monitoring. We hope that we’ve managed to improve your site’s processes for everyone involved and helped you conduct a
better trial. As a sponsor, your task will be to find a good CRA and provide him with a good Monitoring Plan that will enable him to do his
job well. On the other hand, as a site, your job is to follow the CRA’s advice, be available on each visit, and show him all the action items
that he wants to review. Like this, the whole trial process will develop smoothly and without any delays or problems.
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Explaining the Different Types of Routine Monitoring Visits

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