PV Terminology Flashcards
Investigational Product (IP)
Any drug, device, therapy, or intervention after Phase I trial
Event
Any undesirable outcome (ex. lab finding, symptom, disease)
Adverse Event/Experience (AE)
Any related OR unrelated event occurring during use of IP
Adverse Drug Reaction/Effect (ADR/ADE)
AE that is RELATED to the product
Serious Adverse Event (SAE)
AE the causes death, disability, incapacity, is life-threatening, requires/prolongs hospitalization, or leads to birth defect
Unexpected Adverse Event (UAE)
AE that is NOT previously listed on product information
Unexpected Adverse Reaction (ADR)
ADR that is NOT previously listed on product information
Suspected Unexpected Serious Adverse Reaction (SUSAR)
Serious + Unexpected + ADR
Causality Assessment
Review of drug to determine if certain, probably/likely, possible, unlikely, conditional/unclassified, unassessable/unclassifiable
Dechallenge vs. Rechallenge
Causality assessed by measuring AE outcome when withdrawing vs re-admin of IP
Causal Relationship
Causality assessment determined certain, probable/likely, or possible
Seriousness
Based on outcome + guide to reporting obligations
Severity
Based on intensity (mild, moderate, severe) regardless of medical outome
Temporal relationship
Positive if AE timing within use or half-life of drug
Signal
Event info after drug approved providing new adverse or beneficial knowledge about IP that justifies further studying
Identified Risk
Event noticed in signal evaluation known to be related/listed on product information
Potential Risk
Event noticed in signal evaluation scientifically related to product but no listed on product information
Important Risk/Safety Concern
Identified or potential risk that can impact risk-benefit ratio
Risk-Benefit Ratio
Ratio of IPs positive therapeutic effect to risks of safety/efficacy
Summary of Product Characteristics (SmPC/SPC)
Guide for doctors to use IP
