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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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Part I
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CRA Assignments
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CRA Guidelines
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Site Interim
Pre-Audit
Initiation Monitoring
Visits
Visits (for Visits
your sites) (Routine
Monitoring
Visits)
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IVRS/IWRS Knowledge
IP preparing and
IP receiving
administering
IP storage IP accountability
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Part II
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Site Selection Visit
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 Apart from all of these things, the
selected, the terms and budget have CRA will also have to make sure that
been negotiated, and all the documents the coordinator and the PI are both
have been signed. Basically, the site up-to-date with everything and that
cannot start screening patients until the theyre properly trained and have a
site initiation visit happens. Contrary to good understanding of the protocol.
the first type, these visits do require that Next, the CRA will have to make sure
the CRA has more knowledge and that the site has all the login details
understands the protocol in-depth. The for the EDC system as well as all the
site initiation visit entails that the CRA other systems that the site uses,
confirms that all the regulatory make sure that all the laboratory kits
documents are accurate and present, all are present and accounted for, etc.
the IRB reviews are in place, the contract These are some of the basic tasks of
CRA Knowledge Level
and budget are present, the non- a CRA during a site initiation visit,
disclosure agreement is signed and although, in practice, there are many
present, and basically that all other more details that the CRA will be
important documents are accurate. 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:
1 2 3 4 5
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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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