AE classification, reporting, documentation Flashcards
Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Adverse Event
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 aka adverse experience
Process of converting investigators’ “verbatim documentation” terms to standardized “preferred terms”
Coding of Adverse Events
Even if AEs are not related to or caused by the study drug, if they occur while the subject is on study, they must be collected and reviewed by the PI and tracked.
Examples include transfusion reactions, accidental injuries, surgery
True
Adverse Reaction
A suspected adverse reaction mean any adverse event for which there is a reasonable possibility that the drug caused the adverse event.
Reasonable possibility means ther eis evidence to suggest a causal relationship between teh drug and adverse event.
Serious Event or Serious Suspected Adverse Reaction
An adverse events or suspected aderse reaction is considered “serious” if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization.
A persistent, or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
A “Life Threatening Adverse Drug Experience” Defined
Any adverse experience that places the subjec, in the view of the investigator, at immediate risk of death from the reaction as it occurred, or it is suspected that the use or continued use of the product would result in the patient’s death.
Examples: Hemorrhaging (bleed from ruptured blood vessel, especially when profuse) and internal bleeding with rapid drop in blood pressure, Loss of consciousness from increase in pressure on brain
Hospitalization
Admission to the hospital for longer than 24 hours or prolongation of hospital stay due to adverse event
Disability
A substantial disruption of a person’s ability to conduct normal life functions.
Examples: loss of speech, fatigue so great the subject cannot get out of bed at all, loss of memory, paralysis
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 patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition
serious adverse drug experience
The following are examples of _______________.
* Allergic bronchospasm requiring intentive treatment in an ER or at home
* blood dyscrasias - morbid general state, abnormal material in blood
* convulsions that do not result in inpatient hospitalization
* development of drug dependency or drug abuse
important medical events
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
* cerebral thromboembolism and cerebral vasculitis would be unexpected (by virtue of greater specificity) if the IB only listed cerebral vascular accidents
Unexpected Adverse Events
