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ADVERSE EVENT REPORTINGADVERSE EVENT REPORTING
• Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
ADVERSE EVENT
ADVERSE EVENT(CONTD)
• Thus an AE can be any unfavourable and Thus an AE can be any unfavourable and unintended sign, symptom , or disease unintended sign, symptom , or disease temporally associated with the use of temporally associated with the use of medicinal product, whether or not medicinal product, whether or not considered related to the medicinal considered related to the medicinal product.product.
• New products
• All noxious and unintended responses to a
medicinal product related to any dose should
be considered adverse drug reactions. A
causal relationship between product and AE is
at least a reasonable possibility
ADVERSE DRUG REACTION ( ADR )
• Marketed products• All noxious and unintended responses to a
medicinal which occurs at doses normally
used for treatment
ADVERSE DRUG REACTION ( ADR )
Adverse Event
Intensity Seriousness Expectedness
•Mild
•Moderate
• Severe
•Non Serious
•Serious
•Expected
•Unexpected•Related
•Un-related
Causality
• SERIOUS ADVERSE EVENT(SDE)SERIOUS ADVERSE EVENT(SDE)• DeathDeath• Life-threateningLife-threatening• Requires or prolongs hospitalizationRequires or prolongs hospitalization• Disability or incapacityDisability or incapacity• Leads to congenital anomaly or birth defectLeads to congenital anomaly or birth defect
SERIOUSNESS
• MILDMILD• Does not interfere with routine activitiesDoes not interfere with routine activities
• MODERATEMODERATE• Interferes with routine activitiesInterferes with routine activities
• SEVERESEVERE• Impossible to perform routine activitiesImpossible to perform routine activities
INTENSITY ( SEVERITY )
Seriousness serves as a guide for defining regulatory
reporting obligations.
Severity describes the intensity of the event, and may
be of relatively minor medical significance.
EXPECTEDEXPECTED Listed (IB)Listed (IB)
UNEXPECTEDUNEXPECTED UnlistedUnlisted
EXPECTEDNESS
RELATEDRELATED
CertainCertain –direct temporal relation –direct temporal relation
positive rechallengepositive rechallenge
ProbableProbable-No rechallenge information required-No rechallenge information required
PossiblePossible-can be explained by concomitant medication or -can be explained by concomitant medication or
illnessillness
CASUALITY
UNRELATEDUNRELATED
UnlikelyUnlikely-concomitant drugs or disease provide plausible -concomitant drugs or disease provide plausible
explanationexplanation
Unclassified-Unclassified-needs more dataneeds more data
Not assessable-Not assessable-information is insufficient or contradictoryinformation is insufficient or contradictory
CASUALITY
NoneNone InterruptedInterrupted DiscontinuedDiscontinued OtherOther
ACTION TAKEN
1.1. Serious / Expected / UnrelatedSerious / Expected / Unrelated
2.2. Serious / Unexpected / UnrelatedSerious / Unexpected / Unrelated
3.3. Serious / Expected / RelatedSerious / Expected / Related
4.4. Serious / Unexpected / Related (YYY)Serious / Unexpected / Related (YYY)
Adverse Event
Seriousness Expectedness Causality
SCHEDULE Y SCHEDULE Y 7 DAYS7 DAYS
SAE at the site SAE at the site ETHICS COMMITTEEETHICS COMMITTEE
WITHIN 24 HOURSWITHIN 24 HOURS SPONSORSPONSOR WITHIN 15DAYSWITHIN 15DAYS
REGULATORYREGULATORY ALL THE SITESALL THE SITES(PSMR(PSMR))
AUTHORITIESAUTHORITIES
DOCUMENTATION
US FDA US FDA 7 DAYS7 DAYS
SAE at the site SAE at the site ETHICS COMMITTEEETHICS COMMITTEE
WITHIN 24 HOURSWITHIN 24 HOURS SPONSORSPONSOR WITHIN 14DAYSWITHIN 14DAYS
REGULATORY ALL THE SITESREGULATORY ALL THE SITES(PSMR)(PSMR)
AUTHORITIESAUTHORITIES
DOCUMENTATION
NON SERIOUS AENON SERIOUS AE To be captured in Adverse event CRFTo be captured in Adverse event CRF Should be resolvedShould be resolved
All All SAEs SAEs to be informed to the Ethics committee by to be informed to the Ethics committee by the investigatorthe investigator
DOCUMENTATION
Adverse event Non serious AE SAE
Record in CRF Record in CRF Report Expeditedly
Sponsor CRO (24 Hrs), EC (7 working days)
Regulatory authorities (within 15 calendar days)
REPORTING AEs… TIME FRAMES
When reporting an SAE, the site should include the When reporting an SAE, the site should include the following:following: A description of the eventA description of the event
The date of onset and the date of resolution (if any)The date of onset and the date of resolution (if any)
All related symptoms and concurrent illnesses or All related symptoms and concurrent illnesses or
symptomssymptoms
GUIDELINES FOR REPORTING SAEs
The severity and frequency of symptomsThe severity and frequency of symptoms
TreatmentTreatment
Concomitant medicationsConcomitant medications
Relationship to study drugRelationship to study drug
Supporting documentsSupporting documents
Provide additional follow-up information as soon as Provide additional follow-up information as soon as
availableavailable
GUIDELINES FOR REPORTING SAEs
Prepared by
Nicky