SOCRA CCRP Adverse Events 2 — Questions and Answers
Question 1: What is a MedDRA in the context of adverse event reporting?
- Medical Data Records Administration
- Medical Dictionary for Regulatory Activities — a standardized medical terminology for AE coding (Correct answer)
- A medication dosage reference application
- A medical device regulatory approval process
Correct answer: Medical Dictionary for Regulatory Activities — a standardized medical terminology for AE coding
MedDRA (Medical Dictionary for Regulatory Activities) is the internationally standardized medical terminology used to classify and code adverse events in clinical trials.
Question 2: What is the purpose of an Investigator's Brochure (IB) in adverse event management?
- To provide marketing information about the drug
- To serve as the reference document for assessing the expectedness of adverse reactions (Correct answer)
- To list all enrolled subjects and their adverse events
- To guide the investigator in prescribing the drug
Correct answer: To serve as the reference document for assessing the expectedness of adverse reactions
The IB summarizes the clinical and nonclinical data on the investigational product and serves as the reference for determining whether an adverse reaction is expected.
Question 3: If an SAE is reported by an investigator to a sponsor, what is the sponsor required to do?
- Immediately terminate the study
- Evaluate the SAE and report to regulatory authorities if it meets expedited reporting criteria (Correct answer)
- Archive the report without action unless the FDA requests it
- Notify only the site IRB
Correct answer: Evaluate the SAE and report to regulatory authorities if it meets expedited reporting criteria
Sponsors must evaluate SAE reports for seriousness, causality, and expectedness, and report to FDA and other regulatory authorities if expedited reporting criteria are met.
Question 4: What is the Common Terminology Criteria for Adverse Events (CTCAE) used for?
- Coding adverse events into MedDRA terms
- Grading the severity of adverse events on a scale of 1 to 5 (Correct answer)
- Classifying the causal relationship of AEs to study drug
- Standardizing adverse event reporting timelines
Correct answer: Grading the severity of adverse events on a scale of 1 to 5
CTCAE provides a standardized grading scale (Grade 1–5) for classifying the severity of adverse events, widely used in oncology trials.
Question 5: What is an 'expedited report' as opposed to a 'periodic report' for adverse events?
- Expedited reports cover all AEs; periodic reports cover only SAEs
- Expedited reports are required within days for unexpected SAEs; periodic reports (e.g., annual reports) summarize all safety data (Correct answer)
- They are the same report submitted on different schedules
- Expedited reports are submitted by the IRB; periodic reports by the sponsor
Correct answer: Expedited reports are required within days for unexpected SAEs; periodic reports (e.g., annual reports) summarize all safety data
Expedited reports (7 or 15 days) are required for unexpected serious adverse reactions, while periodic safety reports summarize all accumulated safety data on a scheduled basis.
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?
- Wait until the hospitalization resolves to report
- Report the SAE to the sponsor immediately or per the protocol timeline (Correct answer)
- Remove the subject from the study before reporting
- Only document the event in the subject's medical record
Correct answer: Report the SAE to the sponsor immediately or per the protocol timeline
Investigators must report SAEs to the sponsor immediately or within the timeframe specified in the protocol, regardless of whether the hospitalization has resolved.
SOCRA CCRP Adverse Events 2
What is a MedDRA in the context of adverse event reporting?