CATO Associate Safety Reporting & Adverse Events Flashcards

What is the purpose of an Individual Case Safety Report (ICSR)?

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.

Which ICH guideline provides the framework for clinical safety data management and expedited reporting of adverse drug reactions?

Answer: ICH E2A

ICH E2A provides the definitions and standards for clinical safety data management, including criteria for expedited reporting of adverse drug reactions.

Under GCP, what must be included in the source documentation when recording an adverse event?

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.

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

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.

Who is responsible for submitting IND annual safety reports to the FDA for a US clinical trial?

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.

What is a 'follow-up safety report' in clinical trial pharmacovigilance?

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.