SOCRA - Society of Clinical Research Associates Adverse Event Safety Reporting Questions and Answers 2

Question 1

What is the timeframe for reporting unexpected fatal or life-threatening suspected adverse reactions to the FDA?

Accepted Answer

7 calendar days

Answer

Per 21 CFR 312.32, sponsors must report these within 7 calendar days.

Question 2

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

Accepted Answer

An AE is any untoward occurrence regardless of causality; an ADR implies a causal relationship

Answer

An AE is any untoward medical occurrence regardless of causal relationship; an ADR implies at least a reasonable possibility of causal relationship.

Question 3

What information must be included in an expedited safety report?

Accepted Answer

Patient identification, event description, suspect drug information, reporter information, and causality assessment

Answer

Reports must include patient identification, detailed event description, suspect drug information, reporter details, and causality assessment.

Question 4

What is a SUSAR and why is it significant?

Accepted Answer

A Suspected Unexpected Serious Adverse Reaction requiring expedited reporting

Answer

A SUSAR is a serious adverse reaction that is suspected, unexpected, and requires expedited reporting.

Question 5

What is the role of pharmacovigilance during a clinical trial?

Accepted Answer

Collect, assess, and report safety data throughout the trial lifecycle

Answer

Pharmacovigilance is responsible for systematic collection, detection, assessment, monitoring, and prevention of adverse effects.

(SOCRA) Society of Clinical Research Associates Practice Test