PAPER 2026 COMPLETE QUESTIONS
AND VERIFIED ANSWERS GRADED
A+
◉ The term non-clinical studies refers to:
a) Studies in vitro cell culture models
b) Studies in organ culture
c) Studies in animal models
d) Pilot human studies. Answer: Answer:
c) Studies in animal models
◉ Non-clinical studies
a) Should be performed in at least three species
b) Must include a disease animal model
c) Should be sufficient to indicate safety in human studies
d) Are not needed before some human studies. Answer: Answer:
c) Should be sufficient to indicate safety in human studies
Non-clinical studies are animal studies and their main purpose is to
gather data on potential toxicities and adverse effects in animals to
predict safety in humans
, ◉ Toxicology studies in animal models
a) Should be reviewed by qualified experts
b) Assessed for their implications of subject safety
c) a only
d) a and b. Answer: Answer:
d) a and b
Should be reviewed by qualified experts AND assessed for their
implications of subject safety
◉ Clinical trial protocols should reflect
a) Reasonable costs for the clinical trial
b) Minimize sample sizes to reduce risks
c) Sound scientific design
d) The use of control groups whenever possible.. Answer: Answer:
c) Sound scientific design
◉ The responsibility for the protection of clinical trial subjects rests
with
a) IRB/IEC
b) Investigator
c) Sponsor
d) All of the above. Answer: Answer:
d) All of the above