Drug Reaction Management
After completion of this lecture, student will be able
describes the procedure for identifying,
recording and reporting of Adverse
Reactions(AE) and Serious Adverse Reactions (SARs)
also describes the procedure for reporting
Suspected Unexpected Serious Adverse Reactions(SUSARs)
Ø AE/AR Adverse Event/Reaction
Ø SAE/SAR Serious Adverse Event/Reaction
Ø SUSAR Suspected Unexpected Serious Adverse
Ø CTIMP Clinical Trail of an Investigational Manufacturing
Ø NIMP Non Investigational Medicinal Product
Any Untowarded medical occurance in a patient or a clinical trial
participant administered an investigational product, and which does not
necessarily have a causal relationship with the drug
All untowarded and unintended responses to the IMP related
to any dose administered to that participant.
SERIOUS ADVERSE REACTIONS
medical occurance that at any dose
hospitalisation,or prolongation of existing hospitalisation
in persistent or significant disability or incapacity
a congenital anomaly.
UNEXPECTED SERIOUS ADVERSE REACTIONS
trail protocol or IB should include a list of known side effects for each drug
in the study.
• This should be consulted when a SAR occurs, to
determine expectedness. If the event is not listed, or has occurred in a more
serious form,or more frequently than expected, it should be considered to be a
Identifying of Adverse Events
protocol should state whether any NIMPs are to be supplied to participants in
procedure for notifying such adverse events to the Principal Investigator must
be clearly documented in the trail protocol.
trial protocol should define how AEs will be recorded, and states that all SAEs
will be reported to the Sponsor.
may also be identified by support documents, for example clinical biochemistry,
hematology, and radiology.
Assessment of Adverse
must be assessed for seriousness, causality,
expectedness, and severity
is the responsibility of the PI to assess each AE for seriousness, causality, expectedness, and
sponsor should review if a SAR reported to them is expected or not. If the
event is not expected it will be considered as a SUSAR.
CI or PI or delegated medically qualified research team member should make an
assessment of severity for each AR.
assessment should be recorded on the SAE form and reported to the sponsor
according to the following categories:
• Mild: A reaction that is easily tolerated by
• Moderate: A reaction that is sufficiently
discomforting to interfere with normal everyday activities.
A reaction that prevents normal everyday activities
Reporting of Adverse reactions
date of birth
name of the drug *
for which suspect drug was prescribed or tested.
form and strength
dose and regimen (specify units – e.g., mg, ml, mg/kg) ..
date and time of day.
Stopping date and time, or duration of
Provide the same information for
of Suspected Adverse Drug Reaction(s) Full description of reaction(s) including
body site and severity, as well as the criteria for regarding the report as
serious,whenever possible, describe a specific diagnosis for the reaction
date (and time) of onset of reaction
date (and time) or duration of reaction
on recovery; results of specific tests and/or treatment.
fatal outcome, cause of death and its possible relationship to the suspected
reaction; any post-mortem findings.
Other information relevant to facilitate assessment of the case, such as
medical history of allergy, drug or alcohol abuse; family history; findings
from special investigations etc
about the Investigator*
reporting the event to Licensing Authority:
reporting the event to Ethics Committee overseeing the site:
of the Investigator
should be reported to the licensing authority within 14 calendar days
status report to the licensing authority
Responsibilities of Investigator
adequate medical care is provided to the subject
and unexpected AE should be reported to
the sponsor within 24 hrs
• To the EC within 7 working days
reporting of adverse events is done through data collection in case report
events are already known as potential risks when participating in a research
study with a specific investigational product
is important to have a documented baseline assessment that is detailed with
health history and current health issues prior to exposure to the
the participant is exposed to the investigational product, the research team
must document any changes in health that may be due to the research study
product and report these adverse events through normal data collection tools
provided by the sponsor
reports require a brief history of the event
information that is helpful to the reviewers of the reports are:
demographic information, when the participant started the research study, what
research intervention the participant was receiving,
medical history, concomitant medications
exposure to investigational product,
• abnormal labs or diagnostic tests,
• when the study team was notified of the event,
description of the actual event, relationship of the AE to the investigational
• whether the participant was hospitalized,
• the event has resolved or not,
the participant will be removed from the research study or continue to receive
the research product
OF ADVERSE REACTIONS
• Adverse event – Any Untowarded medical
occurance in a patient or a clinical trial participant administered an
investigational product , and which does
not necessarily have a causal relationship with the drug
• Adverse reactions- All untowarded and
unintended responses to the IMP related to any dose administered to that
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