Adverse Drug Reaction Management

Adverse Drug Reaction Management


       Identifying adverse events

       Assessing adverse events

       Reporting adverse reactions


After completion of this lecture, student will be able to:

       Identify adverse events

       Assess adverse events

       Report adverse reactions


Ø  It describes the procedure  for identifying, recording and reporting of Adverse  Reactions(AE) and Serious Adverse Reactions (SARs)

Ø  It 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 Reactions

Ø  CTIMP       Clinical Trail of an Investigational Manufacturing Product

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.


    Any untowarded medical occurance that at any dose

Ø  Results in death

Ø  Is life-threatening

Ø  Requires hospitalisation,or prolongation of existing hospitalisation

Ø  Results in persistent or significant disability or incapacity

Ø  Is a congenital anomaly.


       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

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 Principal Investigator must be clearly documented in the trail protocol.

       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.

Assessment of Adverse Event

       AEs must be assessed for  seriousness, causality, expectedness, and severity

       It is the responsibility of the 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.

Assessment of Severity

Ø  The CI or PI or delegated medically qualified research team member should make an assessment of severity for each AR.

Ø  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

Reporting of Adverse reactions

Ø  Patient details



              Age and date of birth



Ø  Suspected drugs

              Generic name of the drug *

              Indication(s) for which suspect drug was prescribed or tested.

              Dosage form and strength

              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

Ø  Other Treatment(s)

                  Provide the same information for concomitant drugs

Ø  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

Ø  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

Ø  Details about the Investigator*



              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


Responsibilities of Sponsor

       SAE should be reported to the licensing authority within 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

       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

       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

       Most reports require a brief history of the event

       Key information that is helpful to the reviewers of the reports are:

       participant demographic information, when the participant started the research study, what research intervention the participant was receiving,

       previous medical history, concomitant medications

       last 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 product,

        whether the participant was hospitalized,

        the event has resolved or not,

       whether the participant will be removed from the research study or continue to receive the research product



       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 participant

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