CPI Infection Control & Prevention 4

Question 1

A clinical trial site has identified a Clostridioides difficile (C. diff) infection in a participant. Which disinfectant is REQUIRED to decontaminate the environment?

Accepted Answer

Sodium hypochlorite (bleach) solution

Answer

C. difficile spores are resistant to alcohol and many disinfectants; sodium hypochlorite (bleach) is required for effective environmental decontamination.

Question 2

During a clinical trial, which of the following would constitute a breach of aseptic technique when preparing an injectable investigational product?

Accepted Answer

Preparing the product outside a biological safety cabinet

Answer

Injectable investigational products must be prepared in a sterile environment (e.g., biological safety cabinet or ISO 5 clean room) to prevent microbial contamination.

Question 3

Post-exposure prophylaxis (PEP) for HIV after a needlestick should ideally be initiated within:

Accepted Answer

72 hours

Answer

HIV PEP should be started as soon as possible and ideally within 2 hours, but remains effective if initiated within 72 hours of exposure.

Question 4

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?

Accepted Answer

Recommending N95 masks for outdoor activities in dusty areas

Answer

In endemic areas, N95 masks during outdoor activity in dusty environments reduce inhalation of Coccidioides spores, particularly for immunocompromised individuals.

Question 5

Which of the following is the MOST effective method to verify that steam sterilization (autoclave) is functioning correctly?

Accepted Answer

Biological indicators using Geobacillus stearothermophilus spores

Answer

Biological indicators using G. stearothermophilus spores are the gold standard for verifying the lethality of steam sterilization cycles.

(CPI) Certified Physician Investigator Practice Test

(CPI) Certified Physician Investigator Practice Test

CPI Infection Control & Prevention 4