CCA CATO Associate Safety Reporting & Adverse Events 2 — Questions and Answers
Question 1: What is the purpose of an Individual Case Safety Report (ICSR)?
- To summarize all adverse events at study completion
- To report a single patient's adverse event to regulatory authorities and pharmacovigilance databases (Correct answer)
- To document protocol deviations
- To notify the IRB of study amendments
Correct answer: To report a single patient's adverse event to regulatory authorities and pharmacovigilance databases
An ICSR is the standardized report for a single adverse event case submitted to regulatory authorities and pharmacovigilance databases.
Question 2: Which ICH guideline provides the framework for clinical safety data management and expedited reporting of adverse drug reactions?
- ICH E6 (GCP)
- ICH E2A (Correct answer)
- ICH E8
- ICH E10
Correct answer: ICH E2A
ICH E2A provides the definitions and standards for clinical safety data management, including criteria for expedited reporting of adverse drug reactions.
Question 3: Under GCP, what must be included in the source documentation when recording an adverse event?
- Only the severity grade
- Date of onset, description, severity, relationship to IP, action taken, and outcome (Correct answer)
- Only events that required hospitalization
- The subject's insurance information
Correct answer: Date of onset, description, severity, relationship to IP, action taken, and outcome
Adequate AE source documentation includes onset date, description, severity, causality assessment, actions taken, and outcome.
Question 4: What is the distinction between an adverse event (AE) and an adverse drug reaction (ADR)?
- There is no difference; the terms are interchangeable
- An AE is any untoward event regardless of causality; an ADR implies a causal relationship to the medicinal product (Correct answer)
- An ADR is only applicable to marketed drugs, not investigational products
- An AE occurs only in placebo recipients
Correct answer: An AE is any untoward event regardless of causality; an ADR implies a causal relationship to the medicinal product
An AE is any unwanted medical occurrence regardless of whether it is related to the IP; an ADR has an implied causal relationship to the drug.
Question 5: Who is responsible for submitting IND annual safety reports to the FDA for a US clinical trial?
- The Principal Investigator
- The IRB/IEC
- The Sponsor (Correct answer)
- The CRO project manager
Correct answer: The Sponsor
The Sponsor holds the IND and is responsible for submitting the annual IND safety report to the FDA as required by 21 CFR 312.33.
Question 6: What is a 'follow-up safety report' in clinical trial pharmacovigilance?
- A report submitted only when the subject recovers
- An updated report submitted when new information becomes available after the initial SAE report (Correct answer)
- A report filed by the IRB 30 days after the SAE
- A report generated at study lock
Correct answer: An updated report submitted when new information becomes available after the initial SAE report
A follow-up report is submitted when additional clinically relevant information about a previously reported SAE becomes available.
CCA CATO Associate Safety Reporting & Adverse Events 2
What is the purpose of an Individual Case Safety Report (ICSR)?