This document provides an overview of the key components of a clinical trial monitoring plan and basic monitoring visits that a clinical research associate (CRA) needs to be aware of. It discusses the main parts of a monitoring plan including CRA site assignments, guidelines, visit timelines, and types of visits. It also explains the differences between traditional and risk-based monitoring approaches. Finally, it outlines the basic monitoring visits that occur, including site selection, initiation, regular monitoring, and close-out visits. The document is intended to educate both new and experienced CRAs on monitoring best practices.

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Monitoring Plan and Basic Monitoring Visits: Everything
that a CRA Needs to Know
A monitor in a clinical trial is also called a CRA - clinical research associate. This
person is a professional who’s 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 you’re 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,
we’ll explain all the components of a monitoring plan, as well as which are the most
basic and important monitoring visits.
Part 1: Components of a Monitoring Plan
CRA site 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 you’re going to monitor, and then
you’ll be trained on the protocol for every study.

2.
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.
Monitor Visit Timeline
The timeline that you’ll 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. In this timeline, you 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.
Types of Monitor Visits
- Pre-Study Visits (PSVs);
- Site Initiation Visits (for your sites);
- Site Selection Visits (depends on your CRO, you might be sent out to visit
sites that aren’t yours);
- Interim Monitoring Visits (Routine Monitoring Visits): reviewing of the consent
form, reviewing of the source data, reviewing of the EDC data and CRF (case
report forms), patient-reported outcomes (PROs), etc.;
- Close-Out Visit (how will it be conducted, who’s responsible for this visit);
- Pre-Audit Visits;
- Monitor Visit Report (confirmation letter plus all the follow-up letters)
Risk-Based Monitoring vs Traditional Monitoring

3. 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, it’s 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 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 way of monitoring is to increase the efficiency without causing any harm to
data quality or resources. With risk-based monitoring, CRAs will be able to point
their 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. This means that the CRA will know which are the risks
associated with a certain site and all its weak points, so he/she will be able to focus
their attention on those areas. This individualism in risk-based monitoring is the
reason why it’s much more efficient when compared to traditional monitoring.
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 who’s basically guiding the site and making sure that it
acts in compliance.
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 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

4. understand and follow your monitoring tasks and act when something isn’t done
right.
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 you’ll have to follow and
respect throughout the whole duration of the study (until the end of the close-out
visit).
- IP receiving;
- IP preparing and administering;
- IP storage;
- IP accountability (drug accountability);
- Subject dosing compliance;
- Return and destruction of IP;
Orders, shipment, and inventory
In this area, you’ll 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.
Part 2: Basic Monitoring Visits in Clinical Research
Site Selection Visit
This is the first visit that occurs before a study starts. A site selection visit basically
means that a CRA goes to visit a certain site before it can be awarded a study. In
practice, the site that’s interested in conducting a certain study will first fill out a
Feasibility Survey which the sponsor will review. Next, if the sponsor considers you
to be a good option for their study (based on the feasibility survey), they’ll send a
CRA to come for a site selection visit. On this visit, it’s the CRA’s task to confirm that

5. the site actually exists and that everything that they’ve stated in their feasibility
survey matches the real situation. Apart from this, the CRA will also make sure that
the site has enough experience to conduct the study and that they’re able to enroll
the required number of patients. This type of visits is normally pretty
straightforward and easy for CRAs because they don’t require a lot of in-depth
knowledge. However, the CRA still has to be familiar with the study requirements in
order to be a good judge in this scenario.
Site Initiation Visit
The site initiation visit is the second visit in order. 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 they’re 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 a CRA during a site initiation visit, although, in
practice, there are many more details that the CRA will be responsible for.
Regular Monitoring Visits
The third type of visits are the 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 we’ve started explaining about regular monitoring
visits, CRAs should know that there are two types of regular visits - traditional and
risk-based. Traditional monitoring visits require a complete, 100% source data
verification, while risk-based monitoring is focused on individual risk profiles of

6. different sites. Today, risk-based monitoring is beginning to grow in popularity
because it’s more efficient and prevents an unnecessary spending of resources. 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 it’s traditional
monitoring, the CRA will have to do a complete source data verification (checking if
all the reported data matches the originals). However, if it’s 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.
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 isn’t a good fit for their study. No matter
what’s the case, the close-out visit is always the same for the CRA. During this visit,
the CRA will have to ship the IP (investigational product) back to the sponsor - both
used and unused IP, make sure that the lab kits are destroyed, and make sure that
the site has a plan and an arrangement for keeping all the medical records. Another
thing that the CRA will have to check is whether the site has notified the IRB that all
the research for that site and study is finished. Finally, the CRA will have to check
that all the safety reports are signed and filed appropriately, as well as go through
all the other study documentation.
Pre-Audit Visit
The fifth and last type of visit we’re 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 it’s 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 aren’t any mistakes. In short, the CRA has
to make sure that everything is in perfect order, there aren’t any mistakes, and that
the site is completely prepared for an audit.

7. 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 they’ll
use to properly conduct their monitoring visits. Even though CRAs are monitors and
they’re only there to supervise, they’ll 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,
we’ve given you all the details regarding each of these 5 monitoring visits.
Hopefully, we’ve managed to help all present and future CRAs out there to better
understand their roles in clinical research.
Visit ​https://trialjoin.com/research-resources/​ for more articles
Or Call
(415) 873-9709