Infection Control & Prevention Flashcards
7 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 7 Infection Control & Prevention flashcards as text
A clinical trial site has identified a Clostridioides difficile (C. diff) infection in a participant. Which disinfectant is REQUIRED to decontaminate the environment?
Answer: Sodium hypochlorite (bleach) solution
C. difficile spores are resistant to alcohol and many disinfectants; sodium hypochlorite (bleach) is required for effective environmental decontamination.
During a clinical trial, which of the following would constitute a breach of aseptic technique when preparing an injectable investigational product?
Answer: Preparing the product outside a biological safety cabinet
Injectable investigational products must be prepared in a sterile environment (e.g., biological safety cabinet or ISO 5 clean room) to prevent microbial contamination.
Post-exposure prophylaxis (PEP) for HIV after a needlestick should ideally be initiated within:
Answer: 72 hours
HIV PEP should be started as soon as possible and ideally within 2 hours, but remains effective if initiated within 72 hours of exposure.
A clinical trial site is located in a region with endemic Coccidioidomycosis. Which infection prevention measure is MOST relevant for immunocompromised trial participants in this setting?
Answer: Recommending N95 masks for outdoor activities in dusty areas
In endemic areas, N95 masks during outdoor activity in dusty environments reduce inhalation of Coccidioides spores, particularly for immunocompromised individuals.
Which of the following is the MOST effective method to verify that steam sterilization (autoclave) is functioning correctly?
Answer: Biological indicators using Geobacillus stearothermophilus spores
Biological indicators using G. stearothermophilus spores are the gold standard for verifying the lethality of steam sterilization cycles.
In a trial evaluating a wound care product, a participant develops a methicillin-resistant Staphylococcus aureus (MRSA) wound infection. Which isolation precaution should be implemented?
Answer: Contact Precautions
MRSA is transmitted primarily through direct contact, requiring Contact Precautions including gloves and gown for all interactions.
Under FDA regulations, when a clinical trial involves a serious unexpected adverse event potentially related to an infection control failure, the sponsor must submit an IND Safety Report within:
Answer: 7 calendar days if life-threatening, 15 calendar days otherwise
FDA requires expedited IND Safety Reports within 7 calendar days for life-threatening or fatal unexpected serious AEs and within 15 days for other serious unexpected AEs.