NAPSRX CHAPTER 11 (CLINICAL TRIAL) QUESTIONS
WITH SOLUTIONS UPDATED 2026 – 2027 .
Clinical Trial - Correct Answer -A study of human subjects that is intended to ascertain an
investigational product's safety and efficacy by analyzing its...
-clinical
-pharmacological and/or other pharmacodynamic effects
-absorption
-distribution
-metabolism
-excretion
-adverse reactions
Ethical Considerations - Correct Answer -1.) Social Value
2.) Scientific Validity
3.) Fair Subject Selection
4.) Informed Consent
5.) Favorable Risk-Benefit Ratio
6.) Independent Review Board/Independent Ethics Committee (IRB/IEB)
7.) Respect for Human Subjects
Social Value - Correct Answer -Clinical trial is justified based on scientific research, and will
result in improvements in health or advancement of scientific knowledge
1
,- This requirement helps ensure resources are not directed at non-meaningful clinical research
and that human subjects are not exploited
Scientific Validity - Correct Answer -the clinical trial should be conducted methodically with
clear objectives and outcomes that are statistically verifiable
-the preclinical and toxicological data should have been carefully analyzed and should
confirm the scientific finding
-the trial should not be biased, and should be executed without unreasonable caveats and
conditions
Fair Subject Selection - Correct Answer -subjects should be selected based on scientific
objectives and not on whether the subject is privileged or vulnerable, or because of
convenience
-inclusion and exclusion criteria are well thought out and designed to satisfy the scientific
data
-must be documented evidence to support the choice of selection criteria
Informed Consent - Correct Answer -subjects should be informed about the aims, methods,
risks, and benefits of the trial
-the available alternatives should be explained
-subjects should not be pressured to enrolling in trial, and should be allowed to leave
-for young and incapacitated people, proxy decision from their representatives must be
obtained
Favorable Risk-Benefit Ratio - Correct Answer -whether possible clinical trial subjects
should be subjected to minimal risk and maximal benefit
-should be based on proven scientific data gathered from pre-clinical stage
-should not be conducted if there is any doubt about the risk-benefit ration
2
,Independent Review Board/Independent Ethics Committee (IRB/IEC) - Correct Answer -
insures that the independent party assesses the clinical trial to address the question of conflict
interests
-acts as a third party to oversee welfare of the trial subjects and ensure trial is conducted in
accordance to the study
-has a right to stop trial or require procedures and methods be changed
-members: clinicians, scientists, lawyers, religious people, and lay people
Respect for Human Subjects - Correct Answer -subjects should be protected, their progress in
the trial monitored closely and provided with appropriate treatment
-new developments in the trial mush be relayed to subjects without prejudice, and subjects
decisions should be honored
-outcomes must be communicated to the subjects promptly and in an unbiased way
Phase 1 - Correct Answer -the first experiment in which a drug is tested on the human body
-primary aim is to assess the safety of the new drug, pharmacokinetics, and
pharmocodynamics
-10-100 healthy volunteers recruited
-doses increased as trial progresses, monitored closely to check their tolerance and side
effects
-samples taken to evaluate absorption, distribution, metabolism, and evaluation
-observations on how they feel, vital signs, and behavioral matters
Phase 2 - Correct Answer -examines the safety and effectiveness of the drug in a targeted
disease group
-50-500 people, 1-2 years
-has a control group, randomized and blinded to subjects
-helps determine effective dose and the dosing regimen of frequency and duration
-specific clinical endpoints or markers (definitive & surrogate) assess interaction of drug and
disease
-statistical analysis conducted to evaluate the influence of the drug on different patient groups
and determine optimum conditions
3
, Phase 3 - Correct Answer -confirms the efficacy of the drug in a mush larger patient group
-several hundred to tens of thousands of people, 2-5 years
-multi-site trial: conducted in several locations
-pivotal trial: its results determine the effectiveness of the drug
-these results help set drug's dosage, treatment frequency, duration, and target patient group
-results submitted to regulatory authorities to see approval to market the drug
Phase 4 - Correct Answer -post-marketing approval trials to monitor efficacy and side effects
of the drug in an uncontrolled real-life situation
-collect information to observe drugs efficacy, side effects, patients quality of life, and cost-
effectiveness
Investigator - Correct Answer -The person who conducts the trial
- If there is a team, then there is a Principal Investigator
- Responsibility is to ensure that GCP is being implemented in the course of the trial, that the
subject's rights and welfare are respected, that the study's transparency is maintained, and that
there are no conflicts of interest
- Should be able to maintain impartiality, meaning that they should be neither employed by
the Sponsor, nor otherwise expected to benefit financially from the drug's success
Principal Investigator - Correct Answer -Normally an expert in the field of the disease being
investigated
Investigator's Brochure - Correct Answer -A collection of information prepared and updated
by the sponsor for the Investigator
- The information consists of all the data relevant to the drug under investigation
4
WITH SOLUTIONS UPDATED 2026 – 2027 .
Clinical Trial - Correct Answer -A study of human subjects that is intended to ascertain an
investigational product's safety and efficacy by analyzing its...
-clinical
-pharmacological and/or other pharmacodynamic effects
-absorption
-distribution
-metabolism
-excretion
-adverse reactions
Ethical Considerations - Correct Answer -1.) Social Value
2.) Scientific Validity
3.) Fair Subject Selection
4.) Informed Consent
5.) Favorable Risk-Benefit Ratio
6.) Independent Review Board/Independent Ethics Committee (IRB/IEB)
7.) Respect for Human Subjects
Social Value - Correct Answer -Clinical trial is justified based on scientific research, and will
result in improvements in health or advancement of scientific knowledge
1
,- This requirement helps ensure resources are not directed at non-meaningful clinical research
and that human subjects are not exploited
Scientific Validity - Correct Answer -the clinical trial should be conducted methodically with
clear objectives and outcomes that are statistically verifiable
-the preclinical and toxicological data should have been carefully analyzed and should
confirm the scientific finding
-the trial should not be biased, and should be executed without unreasonable caveats and
conditions
Fair Subject Selection - Correct Answer -subjects should be selected based on scientific
objectives and not on whether the subject is privileged or vulnerable, or because of
convenience
-inclusion and exclusion criteria are well thought out and designed to satisfy the scientific
data
-must be documented evidence to support the choice of selection criteria
Informed Consent - Correct Answer -subjects should be informed about the aims, methods,
risks, and benefits of the trial
-the available alternatives should be explained
-subjects should not be pressured to enrolling in trial, and should be allowed to leave
-for young and incapacitated people, proxy decision from their representatives must be
obtained
Favorable Risk-Benefit Ratio - Correct Answer -whether possible clinical trial subjects
should be subjected to minimal risk and maximal benefit
-should be based on proven scientific data gathered from pre-clinical stage
-should not be conducted if there is any doubt about the risk-benefit ration
2
,Independent Review Board/Independent Ethics Committee (IRB/IEC) - Correct Answer -
insures that the independent party assesses the clinical trial to address the question of conflict
interests
-acts as a third party to oversee welfare of the trial subjects and ensure trial is conducted in
accordance to the study
-has a right to stop trial or require procedures and methods be changed
-members: clinicians, scientists, lawyers, religious people, and lay people
Respect for Human Subjects - Correct Answer -subjects should be protected, their progress in
the trial monitored closely and provided with appropriate treatment
-new developments in the trial mush be relayed to subjects without prejudice, and subjects
decisions should be honored
-outcomes must be communicated to the subjects promptly and in an unbiased way
Phase 1 - Correct Answer -the first experiment in which a drug is tested on the human body
-primary aim is to assess the safety of the new drug, pharmacokinetics, and
pharmocodynamics
-10-100 healthy volunteers recruited
-doses increased as trial progresses, monitored closely to check their tolerance and side
effects
-samples taken to evaluate absorption, distribution, metabolism, and evaluation
-observations on how they feel, vital signs, and behavioral matters
Phase 2 - Correct Answer -examines the safety and effectiveness of the drug in a targeted
disease group
-50-500 people, 1-2 years
-has a control group, randomized and blinded to subjects
-helps determine effective dose and the dosing regimen of frequency and duration
-specific clinical endpoints or markers (definitive & surrogate) assess interaction of drug and
disease
-statistical analysis conducted to evaluate the influence of the drug on different patient groups
and determine optimum conditions
3
, Phase 3 - Correct Answer -confirms the efficacy of the drug in a mush larger patient group
-several hundred to tens of thousands of people, 2-5 years
-multi-site trial: conducted in several locations
-pivotal trial: its results determine the effectiveness of the drug
-these results help set drug's dosage, treatment frequency, duration, and target patient group
-results submitted to regulatory authorities to see approval to market the drug
Phase 4 - Correct Answer -post-marketing approval trials to monitor efficacy and side effects
of the drug in an uncontrolled real-life situation
-collect information to observe drugs efficacy, side effects, patients quality of life, and cost-
effectiveness
Investigator - Correct Answer -The person who conducts the trial
- If there is a team, then there is a Principal Investigator
- Responsibility is to ensure that GCP is being implemented in the course of the trial, that the
subject's rights and welfare are respected, that the study's transparency is maintained, and that
there are no conflicts of interest
- Should be able to maintain impartiality, meaning that they should be neither employed by
the Sponsor, nor otherwise expected to benefit financially from the drug's success
Principal Investigator - Correct Answer -Normally an expert in the field of the disease being
investigated
Investigator's Brochure - Correct Answer -A collection of information prepared and updated
by the sponsor for the Investigator
- The information consists of all the data relevant to the drug under investigation
4
