ADVERSE EVENT REPORTING

ADVERSE EVENT
• 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
(CONTD)
• Thus an AE can be any unfavourable and
unintended sign, symptom , or disease
temporally associated with the use of
medicinal product, whether or not
considered related to the medicinal
product.
ADVERSE DRUG REACTION ( ADR )

• 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 Event

Intensity Seriousness Expectedness Causality

•Mild •Non Serious •Expected

•Related
•Moderate •Serious •Unexpected
•Un-related
• Severe
SERIOUSNESS

• SERIOUS ADVERSE EVENT(SDE)

• Death
• Life-threatening
• Requires or prolongs hospitalization
• Disability or incapacity
• Leads to congenital anomaly or birth defect
 INTENSITY ( SEVERITY )
• MILD
• Does not interfere with routine activities

• MODERATE
• Interferes with routine activities

• SEVERE
• Impossible to perform routine activities
 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.

 EXPECTEDNESS
 EXPECTED
 Listed (IB)
 UNEXPECTED
 Unlisted
 CASUALITY
 RELATED
 Certain –direct temporal relation
positive rechallenge
 Probable-No rechallenge information required
 Possible-can be explained by concomitant medication or
illness
 CASUALITY
 UNRELATED
 Unlikely-concomitant drugs or disease provide plausible
explanation
 Unclassified-needs more data
 Not assessable-information is insufficient or contradictory
 ACTION TAKEN
 None
 Interrupted
 Discontinued
 Other
 Adverse Event

Seriousness Expectedness Causality

1. Serious / Expected / Unrelated

2. Serious / Unexpected / Unrelated
3. Serious / Expected / Related
4. Serious / Unexpected / Related (YYY)
DOCUMENTATION
SCHEDULE Y 7 DAYS

SAE at the site ETHICS COMMITTEE

WITHIN 24 HOURS

SPONSOR
WITHIN 15DAYS
REGULATORY ALL THE SITES(PSMR)
AUTHORITIES
DOCUMENTATION
US FDA 7 DAYS

SAE at the site ETHICS COMMITTEE

WITHIN 24 HOURS

SPONSOR
WITHIN 14DAYS
REGULATORY ALL THE SITES(PSMR)
AUTHORITIES
 DOCUMENTATION
 NON SERIOUS AE
 To be captured in Adverse event CRF
 Should be resolved
 All SAEs to be informed to the Ethics committee by
the investigator
 REPORTING AEs… TIME FRAMES
 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)

GUIDELINES FOR REPORTING SAEs
 When reporting an SAE, the site should include the
following:
 A description of the event
 The date of onset and the date of resolution (if any)
 All related symptoms and concurrent illnesses or
symptoms
GUIDELINES FOR REPORTING SAEs
 The severity and frequency of symptoms
 Treatment
 Concomitant medications
 Relationship to study drug
 Supporting documents
 Provide additional follow-up information as soon as
available
Prepared
by
Nicky