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