Adverse event
An unfavorable medical occurrence during treatment, whether or not the treatment caused it. It may be unrelated to the treatment or caused by it.
Adverse drug reaction: A harmful and unintended response to a medicine for which a causal relationship is suspected. Unlike an adverse event, this term implies a suspected link to the medicine.
Adverse event reporting: The collection and communication of unfavorable medical occurrences observed during healthcare or research. Reporting turns individual occurrences into records that can be reviewed for safety signals.
Clinical trial: A research study that prospectively evaluates health interventions in human participants. Adverse events are collected systematically during trials to characterize intervention safety.
Medication error: A preventable mistake in prescribing, dispensing, or using a medication that may cause harm. An error describes a problem in medication use; an adverse event describes an unfavorable occurrence.
Serious adverse event: An adverse event meeting criteria such as death, life threat, hospitalization, disability, or congenital anomaly. Seriousness is defined by outcomes, not by whether treatment caused the event.
Case report form: A standardized document used to collect data about each participant in a clinical study. Study teams use it to record event details consistently.
Informed consent: A process in which a person receives relevant information and voluntarily agrees to participate or undergo care. Consent materials disclose foreseeable risks, while ongoing safety findings may require updates.
Side effect: A secondary effect of a treatment, which may be beneficial, neutral, or harmful. A side effect is attributed to treatment, while an adverse event need not be.
Severity: The intensity or degree of a condition or symptom. Severity describes how bad an event is, separately from whether it meets seriousness criteria.
MedDRA: A standardized medical terminology used to code and classify clinical and safety data. Its terms let reports from different studies be grouped and analyzed consistently.