CPI Adverse Event Management & Reporting Flashcards
6 cards from real CPI practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CPI Adverse Event Management & Reporting flashcards as text
What is the key difference between a 'protocol deviation' and a 'protocol violation' in clinical research?
Answer: A deviation is a minor unplanned departure; a violation is a significant departure that may affect subject safety or data integrity
A protocol deviation is a minor unplanned departure from the approved protocol, while a protocol violation is a significant departure that may impact subject safety, rights, or the integrity of study data.
Which FDA system is used to track post-market adverse event reports for drugs and medical devices?
Answer: FAERS (FDA Adverse Event Reporting System)
FAERS (FDA Adverse Event Reporting System) is the FDA's post-market pharmacovigilance database used to store and analyze adverse event and medication error reports.
What is MedWatch, and when is it used in the context of clinical research?
Answer: The FDA's safety reporting program for reporting serious problems with human medical products
MedWatch is the FDA's Safety Reporting Program, used to report serious adverse events, product quality problems, and medication errors involving FDA-regulated products.
How should an investigator properly document an adverse event in a Case Report Form (CRF)?
Answer: Document all AEs with onset date, duration, severity, relationship to study drug, action taken, and outcome
Complete AE documentation in a CRF requires recording onset date, duration, severity grade, investigator's causality assessment, actions taken, and resolution or outcome.
What determines the 'expectedness' of an adverse reaction in an IND study?
Answer: Whether the reaction is described in the current Investigator's Brochure (IB) or reference safety information
Expectedness is based on whether the adverse reaction is listed in the current Investigator's Brochure or reference safety information for the investigational product.
Which regulatory authority requires sponsors to submit a Development Safety Update Report (DSUR) for investigational drugs?
Answer: ICH member authorities, per ICH E2F guideline
DSURs are required under ICH E2F by ICH member regulatory authorities (including FDA and EMA) as annual comprehensive safety updates for investigational drugs.