GOOD CLINICAL PRACTICE FINAL EXAM 2026 QUESTIONS
AND ANSWERS GRADED A+
✔✔The act by a regulatory authority of conducting an official review of documents,
facilities, records, and any other resources that are deemed by the authority to be
related to the clinical trial and that may be located at the site of the trial, at the sponsor's
and/or CRO's facilities, or at other establishments deemed appropriate by the regulatory
authority. - ✔✔Inspection
✔✔This occurs through an offer of an excessive, unwarranted, inappropriate or
improper reward or other overture in order to obtain compliance.
a. assent
b. coercion
c. informed consent
d. undue influence - ✔✔d. undue influence
✔✔Affirmative agreement to take part in a clinical investigation.
a. assent
b undue influence
c. coercion
d. informed consent - ✔✔a. assent
✔✔Individuals should be treated as autonomous agents and persons with diminished
autonomy are entitled to protection.
a. voluntariness
b. beneficence
c. respect for persons
d. justice - ✔✔c. respect for persons
✔✔A process by which a subject voluntarily confirms his or her willingness to participate
in a particular trial, after having been told of all aspects of the trial that are relevant to
the subject's decision to participate.
a. undue influence
b. informed consent
c. coercion
d. assent - ✔✔b. informed consent
✔✔This occurs when an overt threat of harm is intentionally presented by one person to
another in order to obtain compliance.
a. informed consent
, b. assent
c. coercion
d. undue influence - ✔✔c. coercion
✔✔The operational techniques and activities undertaken within the quality assurance
system to verify that the requirements for quality of the trial-related activities have been
fulfilled.
a. monitoring
b. quality control
c. auditing
d. quality assurance - ✔✔b. quality control
✔✔A procedure in which one or more parties to the trial are kept unaware of the
treatment assignments.
a. placebo
b. informed consent
c. blinding
d. randomization - ✔✔c. blinding
✔✔Language through which a subject is made to waive or appear to waive any of his or
her legal rights, or release or appear to release the investigator, the sponsor, the
institution, or its agents from liability for negligence. - ✔✔Exculpatory
✔✔An individual, company, institution, or organization which takes responsibility for the
initiation, management, and/or financing of a clinical trial.
a. subinvestigator
b. sponsor
c. coordinating investigator
d. principal investigator - ✔✔b. sponsor
✔✔All those planned and systematic actions that are established to ensure that the trial
is performed and the data are generated, documented (recorded), and reported in
compliance with GCP and the applicable regulatory requirements.
a. quality control
b. auditing
c. quality assurance
d. monitoring - ✔✔c. quality assurance
✔✔Any study of a drug or device in humans submitted in a marketing application that
the applicant or FDA relies on to establish that the product is effective or any study in
AND ANSWERS GRADED A+
✔✔The act by a regulatory authority of conducting an official review of documents,
facilities, records, and any other resources that are deemed by the authority to be
related to the clinical trial and that may be located at the site of the trial, at the sponsor's
and/or CRO's facilities, or at other establishments deemed appropriate by the regulatory
authority. - ✔✔Inspection
✔✔This occurs through an offer of an excessive, unwarranted, inappropriate or
improper reward or other overture in order to obtain compliance.
a. assent
b. coercion
c. informed consent
d. undue influence - ✔✔d. undue influence
✔✔Affirmative agreement to take part in a clinical investigation.
a. assent
b undue influence
c. coercion
d. informed consent - ✔✔a. assent
✔✔Individuals should be treated as autonomous agents and persons with diminished
autonomy are entitled to protection.
a. voluntariness
b. beneficence
c. respect for persons
d. justice - ✔✔c. respect for persons
✔✔A process by which a subject voluntarily confirms his or her willingness to participate
in a particular trial, after having been told of all aspects of the trial that are relevant to
the subject's decision to participate.
a. undue influence
b. informed consent
c. coercion
d. assent - ✔✔b. informed consent
✔✔This occurs when an overt threat of harm is intentionally presented by one person to
another in order to obtain compliance.
a. informed consent
, b. assent
c. coercion
d. undue influence - ✔✔c. coercion
✔✔The operational techniques and activities undertaken within the quality assurance
system to verify that the requirements for quality of the trial-related activities have been
fulfilled.
a. monitoring
b. quality control
c. auditing
d. quality assurance - ✔✔b. quality control
✔✔A procedure in which one or more parties to the trial are kept unaware of the
treatment assignments.
a. placebo
b. informed consent
c. blinding
d. randomization - ✔✔c. blinding
✔✔Language through which a subject is made to waive or appear to waive any of his or
her legal rights, or release or appear to release the investigator, the sponsor, the
institution, or its agents from liability for negligence. - ✔✔Exculpatory
✔✔An individual, company, institution, or organization which takes responsibility for the
initiation, management, and/or financing of a clinical trial.
a. subinvestigator
b. sponsor
c. coordinating investigator
d. principal investigator - ✔✔b. sponsor
✔✔All those planned and systematic actions that are established to ensure that the trial
is performed and the data are generated, documented (recorded), and reported in
compliance with GCP and the applicable regulatory requirements.
a. quality control
b. auditing
c. quality assurance
d. monitoring - ✔✔c. quality assurance
✔✔Any study of a drug or device in humans submitted in a marketing application that
the applicant or FDA relies on to establish that the product is effective or any study in
