Safety and Compliance Flashcards

For an IND study, within how many calendar days must the sponsor report an unexpected fatal or life-threatening suspected adverse reaction to FDA?

Answer: 7 calendar days

21 CFR 312.32 requires fatal or life-threatening SUSARs be reported to FDA no later than 7 calendar days after the sponsor learns of them.

Under the HIPAA Safe Harbor method, how many specified identifiers must be removed for data to be considered de-identified?

Answer: 18

Safe Harbor requires removal of 18 identifiers, including names, small geographic units, dates, and record numbers.

A refrigerator storing investigational product logs a temperature excursion overnight. What is the appropriate first action?

Answer: Quarantine the product and notify the sponsor per protocol

Affected product is quarantined and labeled do-not-use until the sponsor assesses stability and gives disposition instructions.

Which ethical principle from the Belmont Report is most directly applied through the informed consent process?

Answer: Respect for persons

Respect for persons recognizes individual autonomy, which is honored by voluntary informed consent.

A study coordinator asks an RA to perform a protocol task not listed for them on the delegation log. What should the RA do?

Answer: Decline until the PI delegates the task and documents it on the log

ICH GCP requires the PI to delegate study tasks only to trained, qualified staff and document this before the work is done.

Which type of fire extinguisher class is designated for fires involving energized electrical equipment in the U.S.?

Answer: Class C

Class C covers energized electrical equipment, while A is ordinary combustibles, B flammable liquids, and D combustible metals.

How many sections does a GHS-compliant Safety Data Sheet (SDS) contain under OSHA's Hazard Communication Standard?

Answer: 16

OSHA HazCom 2012 aligned with GHS requires a standardized 16-section SDS format.