SOCRA Adverse Event Safety Reporting 5

Question 1

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

Accepted Answer

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

Answer

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.

Question 2

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

Accepted Answer

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

Answer

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.

Question 3

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?

Accepted Answer

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

Answer

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.

Question 4

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

Accepted Answer

The sponsor (or sponsor-investigator)

Answer

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

Question 5

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

Accepted Answer

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

Answer

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.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Adverse Event Safety Reporting 5