ACRP CP EXAM SCRIPT COMPLETE
QUESTIONS AND VERIFIED CORRECT
ANSWERS GRADED A+ 2026
◉ What is a clinical research protocol requirement? Answer: A protocol
outlines the specific procedures, interventions, and timelines that must
be followed in a research study. These may include tests or treatments
that go beyond or differ from standard of care.
◉ True or False: Clinical trial procedures always align with standard
medical care. Answer: False. Protocols may include additional or
alternative interventions, assessments, or visits that are not part of usual
care.
◉ What's an example of a difference between standard of care and a
research protocol? Answer: In standard care, a patient with hypertension
might get blood pressure checks every 3 months. In a protocol, they may
be required to return every 2 weeks for blood draws and vitals per study
timeline.
◉ Why is it important to distinguish between standard of care and
research requirements? Answer: To ensure:
Informed consent accurately reflects risks and procedures
,Proper billing compliance (e.g., sponsor vs. insurance)
Ethical clarity—patients know what's research vs. clinical care
◉ What is clinical equipoise? Answer: is the genuine uncertainty within
the expert medical community about whether one treatment in a trial is
better than another. It ethically justifies enrolling participants in a
randomized trial.
◉ Why is clinical equipoise important in research? Answer: It ensures
that no participant is knowingly given inferior treatment, and it upholds
the ethical principle of beneficence in clinical trials.
◉ What is a therapeutic misconception? Answer: Therapeutic
misconception occurs when a research participant believes that the
primary purpose of a clinical trial is to benefit them individually, rather
than to generate generalizable knowledge.
◉ True or False: Participants with therapeutic misconception may not
understand the risks of being randomized. Answer: True. They may
mistakenly assume they'll receive the best treatment, not understanding
that assignments are random and the primary goal is research.
◉ How can research staff reduce therapeutic misconception during
consent? Answer: By clearly explaining:
The purpose of the study (to gather knowledge, not guarantee treatment)
, That randomization or placebo may occur
The differences between research and individualized clinical care
◉ What is the Investigator's Brochure (IB) and how does it protect
subjects? Answer: The IB is a comprehensive summary of the clinical
and non-clinical data on the investigational product. It informs
investigators about risks, safety, dosing, and pharmacology—critical for
protecting participants' safety.
◉ Name 3 key elements of the study protocol that help ensure subject
protection. Answer: Inclusion/exclusion criteria
Safety monitoring procedures
Adverse event reporting requirements
◉ What are the essential elements of an informed consent document?
Answer: Purpose of the study
Risks and benefits
Voluntary participation
Right to withdraw at any time
Alternatives to participation
Confidentiality
Contact information
QUESTIONS AND VERIFIED CORRECT
ANSWERS GRADED A+ 2026
◉ What is a clinical research protocol requirement? Answer: A protocol
outlines the specific procedures, interventions, and timelines that must
be followed in a research study. These may include tests or treatments
that go beyond or differ from standard of care.
◉ True or False: Clinical trial procedures always align with standard
medical care. Answer: False. Protocols may include additional or
alternative interventions, assessments, or visits that are not part of usual
care.
◉ What's an example of a difference between standard of care and a
research protocol? Answer: In standard care, a patient with hypertension
might get blood pressure checks every 3 months. In a protocol, they may
be required to return every 2 weeks for blood draws and vitals per study
timeline.
◉ Why is it important to distinguish between standard of care and
research requirements? Answer: To ensure:
Informed consent accurately reflects risks and procedures
,Proper billing compliance (e.g., sponsor vs. insurance)
Ethical clarity—patients know what's research vs. clinical care
◉ What is clinical equipoise? Answer: is the genuine uncertainty within
the expert medical community about whether one treatment in a trial is
better than another. It ethically justifies enrolling participants in a
randomized trial.
◉ Why is clinical equipoise important in research? Answer: It ensures
that no participant is knowingly given inferior treatment, and it upholds
the ethical principle of beneficence in clinical trials.
◉ What is a therapeutic misconception? Answer: Therapeutic
misconception occurs when a research participant believes that the
primary purpose of a clinical trial is to benefit them individually, rather
than to generate generalizable knowledge.
◉ True or False: Participants with therapeutic misconception may not
understand the risks of being randomized. Answer: True. They may
mistakenly assume they'll receive the best treatment, not understanding
that assignments are random and the primary goal is research.
◉ How can research staff reduce therapeutic misconception during
consent? Answer: By clearly explaining:
The purpose of the study (to gather knowledge, not guarantee treatment)
, That randomization or placebo may occur
The differences between research and individualized clinical care
◉ What is the Investigator's Brochure (IB) and how does it protect
subjects? Answer: The IB is a comprehensive summary of the clinical
and non-clinical data on the investigational product. It informs
investigators about risks, safety, dosing, and pharmacology—critical for
protecting participants' safety.
◉ Name 3 key elements of the study protocol that help ensure subject
protection. Answer: Inclusion/exclusion criteria
Safety monitoring procedures
Adverse event reporting requirements
◉ What are the essential elements of an informed consent document?
Answer: Purpose of the study
Risks and benefits
Voluntary participation
Right to withdraw at any time
Alternatives to participation
Confidentiality
Contact information
