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

30 calendar days

Answer

15 calendar days

Answer

90 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

No difference

Answer

An ADR is less serious

Answer

An AE only occurs during treatment

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

Only the participant's name

Answer

Just the MedWatch form number

Answer

Only drug name and batch number

Question 4

What is a SUSAR and why is it significant?

Accepted Answer

A Suspected Unexpected Serious Adverse Reaction requiring expedited reporting

Answer

Standard Unrelated Safety Assessment Report

Answer

Safety Update Summary for Annual Review

Answer

Supplemental Urgent Safety Alert Request

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

Manage the trial budget

Answer

Recruit participants

Answer

Manufacture the investigational product

Question 6

What is a Development Safety Update Report (DSUR)?

Accepted Answer

An annual report providing comprehensive safety analysis during drug development

Answer

A daily safety summary

Answer

A report only when SAEs occur

Answer

A post-marketing report