MANAGEMENT OF ADVERSE REACTIONS

Presented By Ch. Deepthi

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)

ABBREVATIONS

AE/AR Adverse Event/ReactionSAE/SAR Serious Adverse Event/ReactionSUSAR Suspected Unexpected Serious Adverse ReactionsCTIMP Clinical Trail of an

Investigational Manufacturing ProductNIMP Non Investigational Medicinal Product

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.

DEFINITIONS

SERIOUS ADVERSE REACTIONS Any untowarded medical occurance

that at any doseResults in death Is life-threateningRequires hospitalisation,or prolongation

of existing hospitalisationResults in persistent or significant

disability or incapacity Is a congenital anomaly.

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

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.

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.

Assessment of Adverse EventAEs 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.

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

Reporting of Adverse reactions

Patient detailsInitials GenderAge and date of birthWeightHeightSuspected drugsGeneric name of the drug *.Indication(s) for which suspect drug was

prescribed or tested.Dosage form and strength.

Reporting of Adverse ReactionsDaily 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

treatmentOther Treatment(s) Provide the same information for

concomitant drugs

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.

Reporting of Adverse ReactionsOutcomeInformation 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.

Reporting of Adverse Reactions Details about the Investigator*NameAddressTelephone numberProfession (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. 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

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.

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.

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

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.

IDENTIFYING OF ADVERSE REACTIONS

Has an AE been identified?

Has an AR been

identified?

Is the AE or AR serious?

yes

no

This is a SAR/SAE

Is this IMP Related ?

This is a AE

This is a SAR

This is a SAE

yes

no

IDENTIFYING OF ADVERSE REACTIONS

AE

Is it Serious ?

Yes No

It is a SAE. It is AE.

Is the event related to the IMP?

Yes No

Is the event Expected It is SAE. No Action Required.

(listed in IB,Protocol)

Yes No

It is SAR. It is a SUSAR