SOCRA CCRP Adverse Events 2

Question 1

What is a MedDRA in the context of adverse event reporting?

Accepted Answer

Medical Dictionary for Regulatory Activities — a standardized medical terminology for AE coding

Answer

Medical Data Records Administration

Answer

A medication dosage reference application

Answer

A medical device regulatory approval process

Question 2

What is the purpose of an Investigator's Brochure (IB) in adverse event management?

Accepted Answer

To serve as the reference document for assessing the expectedness of adverse reactions

Answer

To provide marketing information about the drug

Answer

To list all enrolled subjects and their adverse events

Answer

To guide the investigator in prescribing the drug

Question 3

If an SAE is reported by an investigator to a sponsor, what is the sponsor required to do?

Accepted Answer

Evaluate the SAE and report to regulatory authorities if it meets expedited reporting criteria

Answer

Immediately terminate the study

Answer

Archive the report without action unless the FDA requests it

Answer

Notify only the site IRB

Question 4

What is the Common Terminology Criteria for Adverse Events (CTCAE) used for?

Accepted Answer

Grading the severity of adverse events on a scale of 1 to 5

Answer

Coding adverse events into MedDRA terms

Answer

Classifying the causal relationship of AEs to study drug

Answer

Standardizing adverse event reporting timelines

Question 5

What is an 'expedited report' as opposed to a 'periodic report' for adverse events?

Accepted Answer

Expedited reports are required within days for unexpected SAEs; periodic reports (e.g., annual reports) summarize all safety data

Answer

Expedited reports cover all AEs; periodic reports cover only SAEs

Answer

They are the same report submitted on different schedules

Answer

Expedited reports are submitted by the IRB; periodic reports by the sponsor

Question 6

A participant in a clinical trial is hospitalized for a condition the investigator believes is related to the study drug. What should the investigator do first?

Accepted Answer

Report the SAE to the sponsor immediately or per the protocol timeline

Answer

Wait until the hospitalization resolves to report

Answer

Remove the subject from the study before reporting

Answer

Only document the event in the subject's medical record