There are many regulations that we need to take into account in order to make a successful clinical trial!

1. Drug Accountability:
An Important Aspect of Clinical
Research

2. Introduction
Drug accountability is an interesting topic related to
clinical research, both for the CRAs and for the clinical
research sites. Even though drug accountability isn’t a
task that should be performed by the CRA, he or she
is still responsible for monitoring and making sure
that the site is correctly performing every task related
to this field.
The topic of drug accountability is especially
important in regards to quality data as well as for
patient safety. For this reason, we’ll give you an
in-depth explanation of everything that drug
accountability entails.
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What is an IP?
In clinical research, IP stands for
Investigational Product.
The investigational product is the product
that’s being tested - it can be either the
actual active ingredient or a placebo
(depending on the nature of the study).
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IP (Drug) Accountability Steps
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5. Receiving the Study
Drug and IVRS/IWRS
Placing the IP in a Locked
Cabinet/Storage
The drug accountability process
starts even before randomization.
More specifically, it starts as soon
as the site receives the IP. Once the
drugs are received, the site
coordinator has to log in to IVRS
(Interactive Voice Response System)
or IWRS (Interactive Web Response
System), take the shipment
document, and manually check if all
the units stated in the document
are actually in the delivered box
(bottles, etc.) and that they aren’t
damaged.
Step
1
Step
2
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Every research site should
have a locked cabinet with
the appropriate temperature
adjustments for keeping the
investigational drug. So,
after making sure that all the
drugs delivered, place them
in your locked cabinet.
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When it’s time to randomize the
subjects, log in to the IWRS, follow the
instructions on their website, and start
randomizing the subjects. After one
subject is randomized, the website will
give you a number which refers to the
subject’s number for the IP he/she
received on that specific visit. This
number should be then logged into
your IP accountability log in the
specific blank space. After this is done,
you (as the site coordinator) will go to
your drug storage/cabinet, find the
appropriate bottle/unit of IP
(according to the same number) and
give it to the subject.
Subject RandomizationStep
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IP Accountability Log Step
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After you’ve placed the drug
in the locked cabinet/storage,
you’ll fill out and keep an IP
accountability log in a
separate binder. Here, you
will manually enter every
number from every
bottle/unit of IP. After this is
done you will have a list with
all the units of IP. The rest of
the log will be left blank for
now because the product is
still not dispensed to
subjects.
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The IP bottle/unit should
be returned to the site
regardless of whether it’s
completely empty or not.
Once the subject returns
the IP unit, you will enter
the number of returned
pills and the date they
were returned in your IP
accountability log.
Returning of the IP
Step
5
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8. 01 02
06 07
03 04
0805
IP number of every
single unit/bottle
Date when the IP is
received
Date when the IP is
assigned to a subject
Which IP is assigned
to which subject
How many pills were
assigned to each
subject
Date of return of the
IP
How many pills/units
of IP were returned
IP that’s returned to
the sponsor/CRO at
the end of the study
and date
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A filled out IP accountability log should give you the following information:

9. The Importance of Logging Data On Time
Maintaining and entering data in the IP log should
always be done regularly and on time. Many
coordinators forget to enter this data and when this
happens, it can really quickly become a huge mess.
After some time has passed, you won’t remember
which IP is dispensed to which subject. This will
make it really hard to keep track of the IP. For this
reason, it’s important to log in this data anytime
someone takes or returns an IP.
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10. Close-Out Visit
When the study ends, it’s time for a close-out
visit.
On this visit, all your IP should be accounted for.
You should have a completely filled out IP
accountability log, returned (opened) bottles of
used drugs, and unused (closed) drug units that
weren’t assigned to any subjects.
The returned (used) units of IP and the unused
ones will then be shipped back to the sponsor or
CRO, and in the IP log you will fill out the
appropriate field for this.
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CRAs and Drug Accountability
As we mentioned before, the CRA is only the monitor
of the study. This means that he or she is not
responsible for any of the steps explained above.
The CRA will be there to only monitor that the site is
doing this drug accountability and that they’re doing it
correctly and accurately. One of the most important
tasks of a CRA when it comes to drug accountability is
to make sure that the IP log is constantly and properly
maintained and kept up-to-date. After the study ends,
on the close-out visit, the CRA (monitor) will ship the
used and unused units of IP back to the sponsor or
the CRO.
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12. FDA warning letters for drug accountability failures
Usually, the FDA will come for a drug accountability
inspection at your site. Here, they will check and
control if all of your drug accountability processes
and activities are accurate.
If they see that the site fails to comply with all drug
accountability rules and regulations, they will send
you a warning letter.
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Records of incomplete
and/or incorrect
distribution
An adequate
inventory of drugs
was not
maintained so now
records do not
identify recipients
of a particular
batch of the drug
There’s a lack of drug
accountability
registries in relation
to drug transfer
between sites
Not keeping records
of drug distribution
during the study
Shipping invoices
and dispensing
records that in
comparison show
more drugs being
administered than
originally received
You can receive an FDA Warning Letter some of the following problems have been found at your site:

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Issues between forms
of drug administration
and accountability
Non-availability of
dispensing drug
records
Study medication
that is missing or not
accounted for
Inaccurate and/or
inadequate source
documents
The CRO failed to
properly supervise
the clinical trial and
ensure compliance
or stopping of
unreliable clinical
investigators
You can receive an FDA Warning Letter some of the following problems have been found at your site:

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CONCLUSION
To sum up, drug accountability is an important field in clinical research that will allow you to properly keep track of
every single unit of IP. By doing this task correctly and promptly, you will manage to save yourself a lot of time during
the close-out visit, avoid confusion, and improve data integrity and quality. Furthermore, remember that drug
accountability is a task that belongs to the site (usually the site coordinator), not to the CRA. The CRA will only be there
to monitor and make sure that you’re performing these tasks properly. And finally, the most important part of this
whole thing is the IP accountability log. Make sure to fill this out as soon as your IP arrives, and every time a subject
takes or returns the IP. Like this, you will have a clear and completely filled out accountability log which will provide you
with a better outlook on the whole picture. Drug accountability is one of the most important things in clinical research
since it can greatly influence the quality and integrity of study data and results.
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