Adverse Event Management Flashcards

An 'adverse event of special interest' (AESI) differs from a standard SAE in that it:

Answer: Is predefined in the protocol as requiring expedited reporting regardless of standard seriousness criteria

AESIs are protocol-specified events considered scientifically important for the product's benefit-risk assessment and require enhanced or expedited monitoring and reporting even if not classified as serious.

What is the difference between an Adverse Event (AE) and an Adverse Drug Reaction (ADR)?

Answer: An ADR implies at least a possible causal relationship to the study drug, while an AE does not require causality

An AE is any untoward medical occurrence temporally associated with study drug use, regardless of causality; an ADR implies a causal relationship has been at least reasonably suspected.

The 15-day reporting clock for an expedited IND safety report begins when:

Answer: The sponsor first receives minimum valid safety information about the SUSAR

The 15-calendar-day regulatory reporting clock starts when the sponsor receives the minimum information required for a valid case (identifiable patient, reporter, suspect drug, and adverse event).

A 'protocol-defined SAE exemption' means:

Answer: Certain SAEs anticipated by the disease or procedure do not require expedited reporting to the sponsor if specified in the protocol

Protocols may pre-specify SAEs that are expected outcomes of the underlying disease or procedure, exempting them from the standard immediate reporting requirement to reduce reporting burden.

Which entity is responsible for assessing the causality (relatedness) of an adverse event to the investigational product?

Answer: The investigator, and separately the sponsor's medical monitor

Both the investigator and the sponsor's medical monitor independently assess causality; both assessments must be documented and both can be required in regulatory reports.

In clinical trials, 'outcome' for an adverse event typically refers to which of the following classifications?

Answer: Recovered/resolved, recovering/resolving, not recovered/not resolved, recovered with sequelae, fatal, unknown

Standard AE outcome categories describe the resolution status of the event: recovered, recovering, not recovered, recovered with sequelae, fatal, or unknown.