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What To Do When There Are
Adverse Events and Serious Adverse
Events?
Introduction
Clinical trials are experimental studies where the efficiency and safety of a new
drug are being tested. For this reason, patients who decide to participate need to
sign an informed consent form which states that they’re aware of the risks and
benefits associated with the study drug or investigational product. With all this in
mind, it’s expected that as some point, some patients will experience adverse
events or even serious adverse events.
At the site level, it’s important to know what to do when this happens. What do
you do when a patient experiences an adverse event? What do you do when it’s a
serious adverse event? Whose job is it to deal with these cases? Who should
report this and to whom? What should the CRA do? What should the PI and
coordinator do?
All of these questions and the answers to them are crucial in case of such
situations.
2
Defining Adverse Events
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3
According to 21 CFR 312.32(a):
“Adverse event means any untoward medical occurrence
associated with the use of a drug in humans, whether or not
considered drug related.”
Defining Serious Adverse Events
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4
According to 21 CFR 312.32 (a):
“An adverse event or suspected adverse reaction is
considered "serious" if, in the view of either the
investigator or sponsor, it results in any of the following
outcomes:
Death A life-threatening
adverse event
Congenital anomaly/
birth defect
A persistent or
significant incapacity or
substantial disruption of
the ability to consuct
normal life functions
Inpatient hospitalization
or prolongation of
existing hospitalization
1 2 3 4 5
Defining Serious Adverse Events
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5
“Important medical events that may not result in death, be life
threatening, or require hospitalization may be considered a serious
adverse drug experience when, based upon appropriate medical
judgment, they may jeopardize the patient or subject and may
require medical or surgical intervention to prevent one of the
outcomes listed in this definition.” 21 CFR 312.32 (a)
In this sense, “life-threatening” entails that according to the PI, the
subject is at a risk of death at the given moment or that the subject
will be at risk of death if the IP continues being used.
As an example of life-threatening conditions, we have internal
bleeding, a sudden drop in blood pressure, a sudden rise in blood
pressure, loss of consciousness, etc.
What should the CRA do?
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6
01
ensuring that the PI and coordinator record
adverse events and serious adverse events on
the source documents;
02
making sure that all serious adverse events are
reported to the sponsor and the IRB;
03
ensuring that the recorded adverse events are
not actually serious adverse events;
04
making sure that all adverse events and serious
adverse events are recorded in the adverse event
log and later in the EDC system;
05
making sure that the PI is aware of all adverse
and serious adverse events;
The CRA or the monitor at the site does
exactly that – he/she monitors! When it
comes to adverse events or serious adverse
events, the CRA’s job is only to make sure
that they’re properly documented and
reported. It is not the CRA’s job to document
anything or report to anyone!
In this field, the tasks of a CRA are the
following:
What should the PI do?
www.trialjoin.com
7
As a medical professional responsible for the safety and well-being of the
patients, the PI should assess each situation and decide if it’s an adverse event
or a serious adverse event.
Next, the PI should take all necessary measures to ensure that the patient is
taken care of, whether it’s hospitalization, discontinuing the IP, etc.
And finally, it’s usually the PI’s job (if it’s not delegated to the coordinator) to
record adverse events and report all serious adverse events to the sponsor and
the IRB.
What should the coordinator (CRC) do?www.trialjoin.com
8
#1
Often, the PI
will delegate
the task of
recording
adverse events
to the
coordinator, so
this is
something that
he/she has to
do.
#2
Another
important
coordinator
task is to follow
all adverse and
serious adverse
events and
inform the PI
whenever
something
seems urgent or
unclear.
#3
All sponsors and/or
CROs keep metrics that
show them the
percentages of adverse
events and serious
adverse events. This is
done in order to draw a
conclusion regarding
the safety of the drug.
So, if you are failing to
record these events at
your site, while all of
the sponsor’s other
sites have reported
more adverse and
serious adverse events,
the sponsor will know
that you’re
mismanaging your site.
Record all
AE
Record
and
Report all
SAE
What should the Sponsor/CRO do?
www.trialjoin.com
9
● The only task of the sponsor and/or CRO in these
cases is to supervise and keep metrics of all their sites
conducting the same trial.
● These metrics for adverse events and serious adverse
events will show the sponsor when a site doesn’t do
their job properly.
● Regularly check your metrics and see if any site has
much more or less than the average numbers. Like
this, you’ll be able to spot any fraudulent activities or
sites that don’t follow GCP regulations and protocols.
RISK vs BENEFIT ratio
www.trialjoin.com
10
If many patients have reported adverse events or serious adverse
events to the study’s IP (investigational drug), then the risk vs
benefit ratio is considered in order to decide if the study will
continue or be dismissed.
When the risks are greater than the benefits, then the study will be
stopped. But, if it’s established that the benefits are greater than
the risks, then the study may continue.
When it comes to certain patients who experience serious adverse
events in the trial, those patients are free to quit the study or to
continue with a lower dose (if appropriate). In any case, all
participants in a trial have the right to quit whenever they want and
for any reason, without any penalties or consequences.
RISK BENEFIT
www.trialjoin.com
CONCLUSION
Recording adverse events and serious adverse events is crucial for the final data extraction and judging the safety of the new
investigational drug. This is usually the job of the PI or the site coordinator.
When it comes to serious adverse events, the coordinator must immediately notify the PI and report these events to the sponsor
as well as the IRB. This is the only way to conduct a safe and productive trial!
When you’re not sure about a certain event, it’s always better to stay on the safe side and record it, or ask the site PI for guidance
and help.
11

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What to Do When There Are Adverse Events and Serious Adverse Events

  • 1. What To Do When There Are Adverse Events and Serious Adverse Events?
  • 2. Introduction Clinical trials are experimental studies where the efficiency and safety of a new drug are being tested. For this reason, patients who decide to participate need to sign an informed consent form which states that they’re aware of the risks and benefits associated with the study drug or investigational product. With all this in mind, it’s expected that as some point, some patients will experience adverse events or even serious adverse events. At the site level, it’s important to know what to do when this happens. What do you do when a patient experiences an adverse event? What do you do when it’s a serious adverse event? Whose job is it to deal with these cases? Who should report this and to whom? What should the CRA do? What should the PI and coordinator do? All of these questions and the answers to them are crucial in case of such situations. 2
  • 3. Defining Adverse Events www.trialjoin.com 3 According to 21 CFR 312.32(a): “Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.”
  • 4. Defining Serious Adverse Events www.trialjoin.com 4 According to 21 CFR 312.32 (a): “An adverse event or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: Death A life-threatening adverse event Congenital anomaly/ birth defect A persistent or significant incapacity or substantial disruption of the ability to consuct normal life functions Inpatient hospitalization or prolongation of existing hospitalization 1 2 3 4 5
  • 5. Defining Serious Adverse Events www.trialjoin.com 5 “Important medical events that may not result in death, be life threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.” 21 CFR 312.32 (a) In this sense, “life-threatening” entails that according to the PI, the subject is at a risk of death at the given moment or that the subject will be at risk of death if the IP continues being used. As an example of life-threatening conditions, we have internal bleeding, a sudden drop in blood pressure, a sudden rise in blood pressure, loss of consciousness, etc.
  • 6. What should the CRA do? www.trialjoin.com 6 01 ensuring that the PI and coordinator record adverse events and serious adverse events on the source documents; 02 making sure that all serious adverse events are reported to the sponsor and the IRB; 03 ensuring that the recorded adverse events are not actually serious adverse events; 04 making sure that all adverse events and serious adverse events are recorded in the adverse event log and later in the EDC system; 05 making sure that the PI is aware of all adverse and serious adverse events; The CRA or the monitor at the site does exactly that – he/she monitors! When it comes to adverse events or serious adverse events, the CRA’s job is only to make sure that they’re properly documented and reported. It is not the CRA’s job to document anything or report to anyone! In this field, the tasks of a CRA are the following:
  • 7. What should the PI do? www.trialjoin.com 7 As a medical professional responsible for the safety and well-being of the patients, the PI should assess each situation and decide if it’s an adverse event or a serious adverse event. Next, the PI should take all necessary measures to ensure that the patient is taken care of, whether it’s hospitalization, discontinuing the IP, etc. And finally, it’s usually the PI’s job (if it’s not delegated to the coordinator) to record adverse events and report all serious adverse events to the sponsor and the IRB.
  • 8. What should the coordinator (CRC) do?www.trialjoin.com 8 #1 Often, the PI will delegate the task of recording adverse events to the coordinator, so this is something that he/she has to do. #2 Another important coordinator task is to follow all adverse and serious adverse events and inform the PI whenever something seems urgent or unclear. #3 All sponsors and/or CROs keep metrics that show them the percentages of adverse events and serious adverse events. This is done in order to draw a conclusion regarding the safety of the drug. So, if you are failing to record these events at your site, while all of the sponsor’s other sites have reported more adverse and serious adverse events, the sponsor will know that you’re mismanaging your site. Record all AE Record and Report all SAE
  • 9. What should the Sponsor/CRO do? www.trialjoin.com 9 ● The only task of the sponsor and/or CRO in these cases is to supervise and keep metrics of all their sites conducting the same trial. ● These metrics for adverse events and serious adverse events will show the sponsor when a site doesn’t do their job properly. ● Regularly check your metrics and see if any site has much more or less than the average numbers. Like this, you’ll be able to spot any fraudulent activities or sites that don’t follow GCP regulations and protocols.
  • 10. RISK vs BENEFIT ratio www.trialjoin.com 10 If many patients have reported adverse events or serious adverse events to the study’s IP (investigational drug), then the risk vs benefit ratio is considered in order to decide if the study will continue or be dismissed. When the risks are greater than the benefits, then the study will be stopped. But, if it’s established that the benefits are greater than the risks, then the study may continue. When it comes to certain patients who experience serious adverse events in the trial, those patients are free to quit the study or to continue with a lower dose (if appropriate). In any case, all participants in a trial have the right to quit whenever they want and for any reason, without any penalties or consequences. RISK BENEFIT
  • 11. www.trialjoin.com CONCLUSION Recording adverse events and serious adverse events is crucial for the final data extraction and judging the safety of the new investigational drug. This is usually the job of the PI or the site coordinator. When it comes to serious adverse events, the coordinator must immediately notify the PI and report these events to the sponsor as well as the IRB. This is the only way to conduct a safe and productive trial! When you’re not sure about a certain event, it’s always better to stay on the safe side and record it, or ask the site PI for guidance and help. 11