Adverse Event Safety Reporting Flashcards

The Development Safety Update Report (DSUR) must be submitted to regulatory authorities how often?

Answer: Annually, based on the Development International Birth Date (DIBD)

Per ICH E2F, the DSUR is submitted annually based on the Development International Birth Date (DIBD), which is the date of first approval of an IND or equivalent in any country.

Under 21 CFR 312.32, a 'life-threatening adverse drug experience' is defined as one in which:

Answer: The subject was at immediate risk of death at the time of the adverse event

A life-threatening adverse drug experience is one where the subject was at immediate risk of dying at the time of the event — not one that hypothetically could have caused death.

A sponsor identifies a new safety signal in post-marketing surveillance data for a drug also used in an ongoing IND study. What is the sponsor's appropriate action?

Answer: Promptly inform investigators and update the Investigator's Brochure with the new safety information

Sponsors must proactively communicate new safety information to investigators and update the IB, so investigators can reassess risks for enrolled subjects and update consent forms if needed.

Which entity bears primary regulatory responsibility for expedited SAE reporting to the FDA for an IND-sponsored clinical trial?

Answer: The sponsor (or sponsor-investigator)

Under 21 CFR 312.32, the sponsor holds primary regulatory responsibility for submitting expedited IND safety reports directly to the FDA.

What is the difference between an adverse event (AE) and an adverse drug reaction (ADR)?

Answer: An ADR implies a causal relationship to the drug, while an AE does not require one

An AE is any undesirable experience regardless of causality; an ADR (also called a suspected adverse reaction) implies that there is at least a reasonable possibility that the drug caused the event.

An investigator is required to report SAEs to the IRB/IEC within what general timeframe under U.S. regulations?

Answer: As specified in the IRB's own requirements, typically within 7 to 10 days

While federal regulations do not specify a uniform timeframe for investigator-to-IRB SAE reporting, IRBs typically define their own requirements (often 7–10 days for serious unexpected events).

Which of the following best describes the investigator's documentation responsibilities for adverse events during a clinical trial?

Answer: Record all observed and reported AEs with date of onset, severity, duration, outcome, and assessed relationship to study drug

Investigators must comprehensively document all AEs in source records and on CRFs, capturing onset, severity, duration, action taken, outcome, and causality assessment for each event.