Monitoring Plan and Basic Monitoring Visits:

Everything that a CRA

Needs to Know
Introduction

A monitor in a clinical trial is also called a CRA - clinical research

associate. This person is a professional whos responsible for
monitoring the clinical trial and making sure that everything is
according to rules, regulations, and good clinical practice.

Whether you already are a CRA or youre trying to become one, the most
important thing you should be aware of is the monitoring plan. You, as a
CRA or a future CRA, should know what a monitoring plan is, what it
serves for, and what it consists of. The second most important
information for you are the monitoring visits. Below, well explain all the
components of a monitoring plan, as well as which are the most basic
and important monitoring visits.

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Components of a Monitoring Plan

Part I
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CRA Assignments

The first thing that happens before the study starts

is the CRA site assignment.

That means that you will be assigned the sites

which youre going to monitor, and then youll be
trained on the protocol for every study.

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CRA Guidelines

Another thing that happens before the beginning of

the study is the establishment of guidelines for the
CRA.

These guidelines will entail: your internal

communication chain, the person you should
report to (project manager or team leader), your
communication with the site, your communication
with the sponsor, etc. These are the things that will
be stated in the guidelines even before the study
starts.

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Monitor Visit Timeline

The timeline that youll 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 na
ra d i ti o
ee ks
12 w
T
every 6 to 12 weeks. In this timeline, you will also l
enter any schedule changes that might occur n i t or
in 6 to
M o
throughout the duration of each study. Such g
changes in the schedule should always be
reported to the CRO as well as the site. The
k-
communication method of scheduling and w e eks Ris d
e
6 Bas orin
notifying all parties should also be stated and 4 to nt
i
Mo g
explained in the timeline.

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Types of Monitor Visits

Pre-Study Site Selection Close-Out Monitor Visit

Visits (PSVs) Visits Visit Report

Site Interim
Pre-Audit
Initiation Monitoring
Visits
Visits (for Visits
your sites) (Routine
Monitoring
Visits)
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Traditional Monitoring vs
Monitoring
Traditional monitoring is a term
used to describe monitoring based
only on source data verification
(checking the validity of all reported
data by comparing it to originals).
However, its known that this way of
monitoring might require
unnecessary resources that could
be better spent elsewhere. For this
reason, the FDA has proposed a
new method of monitoring known
as risk-based monitoring.
Risk-Based
Risk-based monitoring entails the allocation
of resources based on risk profiles and
areas of need instead of spending these
resources everywhere equally. The aim of
this monitoring is to increase the efficiency
without causing any harm to data quality.
With risk-based monitoring, CRAs will be
able to focus toward the more risky areas
of different sites and work more
strategically. Nowadays, more and more
people prefer and use this type of
monitoring over the traditional one. One of
the most important features of risk-based
monitoring is the individual profile for each
site.
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Problems and Adverse

Events
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 of patients as well as the
good performance of the site. The
CRA is the person whos basically
guiding the site and making sure
that it acts in compliance.
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IVRS/IWRS Knowledge

IVRS stands for Interactive Voice Response

System and IWRS for Interactive Web
Response System. 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 whos responsible for monitoring the
whole drug accountability and
randomization process, you should be
familiar with the way these systems work. In
this way, youll be able to better understand
and follow your monitoring tasks and act
when something isnt done right.
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www.trialjoin.com Investigational Product (IP)
Knowledge
Knowledge of the investigational product is also important for a CRA. You will be presented with a plan for
each of the areas below which youll have to follow and respect throughout the whole duration of the
study (until the end of the close-out visit).

IP preparing and
IP receiving
administering

IP storage IP accountability

Subject dosing Return and destruction of

compliance the IP
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Orders, shipment, and inventory

In this area, youll have to monitor and make sure

that the site takes proper actions regarding orders,
shipment, and inventory storage.

An example of such things are equipment, lab kits,

properly regulated storage areas, etc.

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Basic Monitoring Visits

in Clinical Research

Part II
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Site Selection Visit

A site selection visit means that a CRA goes to

visit a certain site before it can be awarded a
study.

In practice, the site thats interested in Apart from this, the CRA will
conducting a certain study will first fill out also make sure that the site has
a Feasibility Survey which the sponsor enough experience to conduct
will review. Next, if the sponsor considers the study and that theyre able
you to be a good option for their study to enroll the required number
(based on the feasibility survey), theyll of patients. This type of visits is
send a CRA to come for a site selection normally pretty straightforward
visit. On this visit, its the CRAs task to and easy for CRAs because they
confirm that the site actually exists and dont require a lot of in-depth
that everything that theyve stated in knowledge. However, the CRA
their feasibility survey matches the real still has to be familiar with the
situation. study requirements in order to
CRA Knowledge Level be a good judge in this
scenario.
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Site Initiation Visit
This visit happens after the site has been
selected, the terms and budget have
been negotiated, and all the documents
have been signed. Basically, the site
cannot start screening patients until the
site initiation visit happens. Contrary to
the first type, these visits do require that
the CRA has more knowledge and
understands the protocol in-depth. The
site initiation visit entails that the CRA
confirms that all the regulatory
documents are accurate and present, all
the IRB reviews are in place, the contract
and budget are present, the non-
disclosure agreement is signed and
present, and basically that all other
important documents are accurate.
Apart from all of these things, the
CRA will also have to make sure that
the coordinator and the PI are both
up-to-date with everything and that
theyre properly trained and have a
good understanding of the protocol.
Next, the CRA will have to make sure
that the site has all the login details
for the EDC system as well as all the
other systems that the site uses,
make sure that all the laboratory kits
are present and accounted for, etc.
These are some of the basic tasks of
CRA Knowledge Level
a CRA during a site initiation visit,
although, in practice, there are many
more details that the CRA will be
responsible for.
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Regular Monitoring Visits

These are the visits that require the most in terms of CRA experience and
knowledge of the protocol. However, almost all monitors (CRAs) are only
given one study at a time - which means only one protocol to learn and
understand. Even though a CRA could be given multiple sites to handle, most
of them will be doing the same study, which makes this job a bit easier.

Since weve started explaining about regular monitoring visits, CRAs should
know that there are two types of regular visits - traditional and risk-based. In
any case, every CRA will have a monitoring plan which will explain what type
of monitoring visits are required. Depending on the type of monitoring visits,
the CRA will know what he/she is supposed to do on these regular visits. So, if
its traditional monitoring, the CRA will have to do a complete source data
verification (checking if all the reported data matches the originals). However, CRA Knowledge Level
if its a risk-based monitoring, then the CRA will only focus on the areas which
the sponsor considers to be risky for that site and study.

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Site Close-Out Visit
The close-out visit takes place when the study has already finished. A study can end for various reasons, either
because it has been successfully completed or the sponsor dropped the study or even when the sponsor dropped the
site because he/she decided that this particular site isnt a good fit for their study. No matter whats the case, the close-
out visit is always the same for the CRA, whose job would be to:

Check if the site Check that all the

Make sure that the
Ship the IP back Make sure that the site has a plan and has notified the safety reports are
to the sponsor - lab kits are IRB that all the signed and filed
an arrangement
both used and destroyed; research for that appropriately, as
for keeping all the
unused IP; site and study is well as all the other
medical records;
finished; documentation;

1 2 3 4 5

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www.trialjoin.com Pre-Audit Visit

The fifth and last type of visit were going to explain to

you is the pre-audit visit. As the name itself entails, the
pre-audit visit is when the monitor (CRA) comes at the
site to prepare it or make sure that its prepared for an
upcoming audit. This audit can be the FDA, the sponsor,
etc. In this case, the CRA will look for any protocol
deviations, check IP accountability, PI oversight, and
basically check all the documentation and make sure
that there arent any mistakes. In short, the CRA has to
make sure that everything is in perfect order, there arent
any mistakes, and that the site is completely prepared
for an audit.

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CONCLUSION
All of these things that we explained above are part of a monitoring plan. As we said before, CRAs will receive
guidelines and plans for each item above which theyll use to properly conduct their monitoring visits. Even though
CRAs are monitors and theyre only there to supervise, theyll have to be equipped with all this knowledge in order
to be able to point their sites to the right direction. A huge part of the monitoring plan are the monitoring visits. In
the second part of this short guide, weve given you all the details regarding each of these 5 monitoring visits.
Hopefully, weve managed to help all present and future CRAs out there to better understand their roles in clinical
research.

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