Safety and Compliance Flashcards

In the RACE fire response acronym used in clinical settings, what does the 'C' stand for?

Answer: Contain the fire by closing doors

RACE stands for Rescue, Alarm, Contain, and Extinguish or Evacuate.

A tube breaks inside a centrifuge while spinning blood samples. What is the safest initial action?

Answer: Keep the lid closed and wait for aerosols to settle before opening

Leaving the lid closed for a period, typically about 30 minutes, lets infectious aerosols settle before cleanup.

NIH policy requires staff involved in NIH-funded clinical trials to complete GCP training how often?

Answer: Every 3 years

NIH expects Good Clinical Practice training to be refreshed at least every three years.

After an FDA inspection of a research site, which form lists the investigator's inspectional observations?

Answer: Form FDA 483

Form FDA 483 is issued at the close of an inspection to document objectionable conditions observed.

A laptop with unencrypted identifiable health data from 600 participants is stolen. Under HIPAA, what is the outer limit for notifying affected individuals?

Answer: Without unreasonable delay, no later than 60 days after discovery

The HIPAA Breach Notification Rule requires individual notice without unreasonable delay and within 60 calendar days of discovery.

Which biosafety cabinet is most commonly used to protect personnel, product, and the environment when handling BSL-2 agents?

Answer: Class II

Class II BSCs provide personnel, product, and environmental protection and are standard for BSL-2 work.

A participant's study visit occurred outside the protocol-defined window. How should the RA handle it?

Answer: Document it as a protocol deviation and report per IRB and sponsor requirements

Departures from the protocol must be accurately documented and reported as deviations, never concealed by altering records.