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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.  
 
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 
 
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 
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 
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 
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.  
 
 
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 
 
 

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