ICH E2A Definitions and Standards for Expedited Reporting Flashcards
University of Cali slideshow
Define Adverse Event
An untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a casual relationship with this treatment.
An ____________ can be any unfavorable and unintended sign (e.g. an abnormal lab finding), symptom, or disease temporarily associated with the use of a drug, without any judgment about causality or relationship to the drug.
adverse event
Define Serious Adverse Event
death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Hospitalization
Admission to the hospital for longer than 24 hours or prolongation of hospital stay due to adverse event
Congenital Anomaly
Exposure to a medical product prior to conception or during pregnancy resulting in an adverse outcome in the child.
Example: Thalidomide - babies born with deformed arms and legs
Important medical events that may not result in death, be life threatening, or require hospitalization may be considered a ____________________ when based upon appropriate medical judgment (they may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition)
serious adverse event
Toxicities from the study drug are consdiered expected (vs unexpected) if found in…
- safety info on approved products is reflected in product labeling (package insert)
- up to date safety info on the products under investigation is found in the Investigator’s Brochure
- from these sources the protocol and ICF is written to explain and describe what risks we currently expect from this study drug
- safety profile of other drugs in this same class
Define an Unexpected Adverse Event
An adverse event or suspected adverse reaction is considered “unexpected” if it is not listed in the investigator brochure or is not listed at the specificity or severity that has been observed; or, if an investigator brochure is not required, available, is not consistent with the risk info described in the general investigational plan or elsewhere in the current application, as amended.
The following are examples of ________________
- hepatic necrosis would be unexpected (by virtue of greater severity) if the investigator brochure only referred to elevated hepatic enzymes or helpatitis
- cerbral thromboembolism and cerebral vasculitis would be unexpected (by virtue of greater specificity) if the IB only listed cerebral vascular accidents
Unexpected Adverse Events
Severity vs Serious
Severity: Refers to the intensity of the event. Is expressed in ‘grades’ of severity. Event itself may be minor (severe headache)
Serious: events that threaten subjects life or functioning
It is the reponsibility of the ___________ to concur with all intensity assessments added to the database for the events identified in the subject
Principal Investigator
Adverse Drug Reaction
All noxious and unintended responses to medicinal product related to any dose should be considered adverse drug reactions.
“responses to medicinal products” means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out
Unexpected Adverse Drug Reaction
An adverse reaction which the nature or severity of which is not consistent with the applicable product information (e.g. Investigator’s Brochure for an unapproved investigational medicinal product)
life threatening
RISK OF DEATH AT THE TIME OF THE EVENT
-It does not refer to an event which hypothetically might have caused death if it were more severe.
Standards for Expedited Reporting: AE must be
- Serious
- Unexpected
- Related (reasonable suspected causal relationship to IP)
