Drug Accountability:

An Important Aspect of Clinical

Research
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 isnt 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, well 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

thats 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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Receiving the Study Step

Drug and IVRS/IWRS 1
The drug accountability process
starts even before randomization.
More specifically, it starts as soon
Step Placing the IP in a Locked
as the site receives the IP. Once the
Cabinet/Storage
drugs are received, the site 2
coordinator has to log in to IVRS
Every research site should
(Interactive Voice Response
have a locked cabinet with
System) or IWRS (Interactive Web
the appropriate
Response System), take the
temperature adjustments
shipment document, and manually
for keeping the
check if all the units stated in the
investigational drug. So,
document are actually in the
after making sure that all
delivered box (bottles, etc.) and
the drugs delivered, place
that they arent damaged.
them in your locked cabinet.
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IP Accountability Log
After youve placed the drug
in the locked cabinet/storage,
youll 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.
Step
3
Step Subject
4 When Randomization
its 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
subjects 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. 6
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Returning of the IP
Step
The IP bottle/unit should 5
be returned to the site
regardless of whether its
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.

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A filled out IP accountability log should give you the following information:
0 0
1 2
IP number of every Date when the IP is
single unit/bottle received
0 0
5 6
How many pills were Date of return of the
assigned to each IP
subject
0 0
3 4
Date when the IP is Which IP is assigned
assigned to a subject to which subject
0 0
7 8
How many pills/units IP thats returned to
of IP were returned the sponsor/CRO at
the end of the study
and date
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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 wont remember

which IP is dispensed to which subject. This will
make it really hard to keep track of the IP. For this
reason, its important to log in this data anytime
someone takes or returns an IP.

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Close-Out Visit

When the study ends, its 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
werent 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 theyre 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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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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You can receive an FDA Warning Letter some of the following problems have been found at your site:

! ! ! ! !

Records of incomplete An adequate Theres a lack of drug Not keeping records Shipping invoices
and/or incorrect inventory of drugs accountability of drug distribution and dispensing
distribution was not registries in relation during the study records that in
maintained so now to drug transfer comparison show
records do not between sites more drugs being
identify recipients administered than
of a particular originally received
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You can receive an FDA Warning Letter some of the following problems have been found at your site:

! ! ! ! !

Issues between forms Non-availability of Study medication Inaccurate and/or The CRO failed to
of drug administration dispensing drug that is missing or not inadequate source properly supervise
and accountability records accounted for documents the clinical trial and
ensure compliance
or stopping of
unreliable clinical
investigators
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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 youre 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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