Adverse Event Reporting & Safety Monitoring Flashcards

Causality assessment in adverse event reporting refers to:

Answer: Evaluating the likelihood that the investigational product caused the adverse event

Causality (or attribution) assessment evaluates the causal relationship between the investigational product and the adverse event, typically categorized as unrelated, unlikely, possible, probable, or definite.

The Common Terminology Criteria for Adverse Events (CTCAE) is a standardized system used to:

Answer: Grade adverse event severity on a numerical scale from 1 to 5

The NCI's CTCAE provides standardized severity grading: Grade 1 (mild) through Grade 5 (death), enabling consistent adverse event characterization across trials.

Which of the following is NOT among the standard regulatory criteria for classifying an adverse event as 'serious'?

Answer: Resulted in an isolated clinically significant laboratory abnormality

The six standard SAE criteria (ICH E6) are death, life-threatening, hospitalization, disability, congenital anomaly, and medically important events — an isolated lab abnormality alone does not meet the definition unless deemed medically important.

In clinical trial practice, who is primarily responsible for assessing the causal relationship between the investigational product and an adverse event?

Answer: The principal investigator or a qualified designee

The principal investigator (or a qualified clinical designee) at the site is responsible for assessing causality for each adverse event based on clinical judgment and knowledge of the participant's medical history.

What is the primary purpose of an IND Safety Report submitted by a sponsor to the FDA?

Answer: To promptly inform FDA and all investigators of unexpected serious adverse drug reactions

IND Safety Reports (Expedited Safety Reports) are submitted to inform FDA and all investigators of unexpected serious ADRs so that participant safety across all sites can be protected.

Under FDA regulations, when a sponsor receives or becomes aware of a fatal or life-threatening unexpected serious adverse drug reaction, they must notify FDA within 7 days and:

Answer: Notify all investigators as soon as possible, also within 7 calendar days

Sponsors must notify FDA within 7 days and simultaneously distribute the IND Safety Report to all investigators as quickly as possible, consistent with the 7-day reporting timeframe.

When an investigator receives an IND Safety Report from the sponsor, the investigator is required to:

Answer: Submit it to the IRB as required by IRB policy and assess impact on participants

Upon receiving an IND Safety Report, investigators must submit it to the IRB per IRB requirements and assess whether ongoing participants need any safety-related actions, such as consent form updates.