1. MANAGEMENT OF
ADVERSE REACTIONS
Presented By
Ch. Deepthi

2. INTRODUCTION
 It describes the procedure for identifying,
recording and reporting of Adverse
Reactions(AE) and Serious Adverse Reactions
(SARs)
 It also describes the procedure for reporting
Suspected Unexpected Serious Adverse
Reactions(SUSARs)

3. ABBREVATIONS
 AE/AR
Adverse Event/Reaction
 SAE/SAR Serious Adverse Event/Reaction
 SUSAR
Suspected Unexpected Serious
Adverse Reactions
 CTIMP Clinical Trail of an Investigational
Manufacturing Product
 NIMP
Non Investigational Medicinal
Product

4. DEFINITIONS
ADVERSE EVENTS
Any Untowarded medical occurance in a patient
or a clinical trail 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
participant.

5. DEFINITIONS
SERIOUS ADVERSE REACTIONS
Any untowarded medical occurance that at any
dose
 Results in death
 Is life-threatening
 Requires hospitalisation,or prolongation of
existing hospitalisation
 Results in persistent or significant disability or
incapacity
 Is a congenital anomaly.

6. DEFINITIONS
SUSPECTED UNEXPECTED SERIOUS
ADVERSE REACTIONS
 The 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 SUSAR

7. Identifying of Adverse Events
 The trial protocol should define how AEs will
be recorded, and states that all SAEs will be
reported to the Sponsor.
 AEs may also be identified by support
documents, for example clinical
biochemistry, hematology, and radiology.

8. Identifying of Adverse Events
 The protocol should state whether any NIMPs
are to be supplied to participants in the trail.
 The procedure for notifying such adverse
events to the CI or PI must be clearly
documented in the trail protocol.

9. Assessment of Adverse Event
 AEs must be assessed for seriousness, causality,
expectedness, and severity
 It is the responsibility of the CI or PI to assess
each AE for seriousness, causality,
expectedness, and severity
 The 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.

10. Assessment of Severity
 The CI or PI or delegated medically qualified
research team member should make an assessment
of severity for each AR.
 The 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 the
subject.
Moderate: A reaction that is sufficiently
discomforting to interfere with normal everyday
activities.
Severe: A reaction that prevents normal everyday
activities

11. Reporting of Adverse reactions
 Patient details
Initials
Gender
Age and date of birth
Weight
Height
 Suspected drugs
Generic name of the drug *.
Indication(s) for which suspect drug was
prescribed or tested.
Dosage form and strength.

12. Reporting of Adverse Reactions
Daily dose and regimen (specify units - e.g., mg,
ml, mg/kg) ..
Route of administration.
Starting date and time of day.
Stopping date and time, or duration of
treatment
 Other Treatment(s)
Provide the same information for
concomitant drugs

13. Reporting of Adverse Reactions
 Details 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. *
Start date (and time) of onset of reaction.
Stop date (and time) or duration of reaction.

14. Reporting of Adverse Reactions
 Outcome
Information on recovery; results of specific tests
and/or treatment.
For a fatal outcome, cause of death and its
possible relationship to the suspected
reaction; any post-mortem findings.
Any 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.

15. Reporting of Adverse Reactions
 Details about the Investigator*
Name
Address
Telephone number
Profession (speciality)
Date of reporting the event to Licensing
Authority:
Date of reporting the event to Ethics
Committee overseeing the site:
Signature of the Investigator

16. Responsibilities
Responsibilities of Sponsor
 SAE should be reported to the licensing
authority with in 14 calendar days.
 Submit status report to the licensing authority
periodically
.
Responsibilities of Investigator
 Ensure adequate medical care is provided to the
subject
 SAE and unexpected AE should be reported to
the sponsor within 24 hrs
 To the EC within 7 working days

17. Responsibilities
 Regular reporting of adverse events is done
through data collection in case report forms.
 Adverse events are already known as
potential risks when participating in a
research study with a specific investigational
product.
 It is important to have a documented baseline
assessment that is detailed with health
history and current health issues prior to
exposure to the investigational product.

18. Responsibilities
 As 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.

19. Responsibilities
 Most reports require a brief history of the
event.
 Key information that is helpful to the
reviewers of the reports are:
o participant demographic information,
when the participant started the research
study, what research intervention the
participant was receiving,
o previous medical history, concomitant
medications

20. Responsibilities
o last exposure to investigational product,
abnormal labs or diagnostic tests,
o when the study team was notified of the
event, description of the actual
event, relationship of the AE to the
investigational product,
o whether the participant was hospitalized,
the event has resolved or not,
o whether the participant will be removed
from the research study or continue to
receive the research product.

21. IDENTIFYING OF ADVERSE REACTIONS
Has an AE been
identified?
Has an AR been
identified?
Is the AE or AR serious?
y
e
s
n
o
This is a SAR/SAE
Is this IMP Related ?
y
e
s
This is a
SAR
n
o
This is a
SAE
This is a AE

22. IDENTIFYING OF ADVERSE REACTIONS
AE
Is it Serious ?
Yes
It is a SAE.
No
It is AE.
Is the event related to the IMP?
Yes
No
Is the event Expected
(listed in IB,Protocol)
Yes
It is SAR.
No
It is a SUSAR
It is SAE. No Action Required.