GOOD CLINICAL PRACTICE EXAM SCRIPT 2026 QUESTIONS
AND ANSWERS GRADED A+
✔✔Any untoward medical occurrence in a patient or clinical investigation subject
administered a pharmaceutical product and which does not necessarily have a causal
relationship with this treatment.
a. adverse drug reaction
b. serious adverse event
c. unexpected adverse drug reaction
d. adverse event - ✔✔d. adverse event
✔✔A document that describes the objective, design, methodology, statistical
considerations, and organization of a trial and usually also gives the background and
rationale for the trial.
a. clinical study report
b. informed consent form
c. essential document
d. protocol
e. audit report - ✔✔d. protocol
✔✔A standard for the design, conduct, performance, monitoring, auditing, recording,
analyses, and reporting of clinical trials that provide assurance that the data and
reported results are credible and accurate and that the rights, integrity, and
confidentiality or that subjects are protected.
a. good manufacturing practice
b. good clinical practice
c. good laboratory practice
d. good pharmacovigilance practice - ✔✔b. good clinical practice
✔✔A person, who is independent of the trial, who cannot be unfairly influenced by
people involved with the trial, who attends the informed consent process if the subject or
the subject's legally acceptable representative cannot read, and who reads the informed
consent form and any other written information supplied to the subject.
a. impartial witness
b. trial subject
c. sub-investigator - ✔✔a. impartial witness
✔✔A committee that may be established by the sponsor to assess at intervals the
progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to
recommend to the sponsor whether to continue, modify, or stop a trial. -
✔✔Independent Data Monitoring Committee
, ✔✔An independent body constituted of a medical, scientific, and non-scientific
members, whose responsibility is to ensure the protection of the rights, safety and well-
being of human subjects involved in a trial by, among other things, reviewing,
approving, and providing continuing review of trial protocol and amendments and of the
methods and material to be used in obtaining and documenting informed consent of the
trial subjects. - ✔✔Institutional Review Board
✔✔The act of overseeing the progress of a clinical trial, and of ensuring that it is
conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and
the applicable regulatory requirements. - ✔✔Monitoring
✔✔A written, dated, and signed agreement between two or more involved parties that
sets out any arrangements on delegation and distribution of tasks and obligations and, if
appropriate, on financial matters. - ✔✔Contract
✔✔Detailed, written instructions to achieve uniformity of the performance of a specific
function. - ✔✔Standard Operating Procedures
✔✔A systemic and independent examination of trial related activities and documents to
determine whether the evaluated trial related activities were conducted, and the data
were recorded, analyzed and accurately reported according to the protocol, sponsor's
SOPs, GCP, and the applicable regulatory requirements. - ✔✔Audit
✔✔A person or an organization (commercial, academic, or other) hired by the sponsor
to perform one or more of a sponsor's trial-related duties and functions. - ✔✔Contract
Research Organization
✔✔A printed, optical, or electronic document designed to record all of the protocol
required information to be reported to the sponsor on each trial subject. - ✔✔Case
Report Form
✔✔A compilation of the clinical and nonclinical data on the investigational product which
is relevant to the study of the investigational product in human subjects. -
✔✔Investigator's Brochure
✔✔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
AND ANSWERS GRADED A+
✔✔Any untoward medical occurrence in a patient or clinical investigation subject
administered a pharmaceutical product and which does not necessarily have a causal
relationship with this treatment.
a. adverse drug reaction
b. serious adverse event
c. unexpected adverse drug reaction
d. adverse event - ✔✔d. adverse event
✔✔A document that describes the objective, design, methodology, statistical
considerations, and organization of a trial and usually also gives the background and
rationale for the trial.
a. clinical study report
b. informed consent form
c. essential document
d. protocol
e. audit report - ✔✔d. protocol
✔✔A standard for the design, conduct, performance, monitoring, auditing, recording,
analyses, and reporting of clinical trials that provide assurance that the data and
reported results are credible and accurate and that the rights, integrity, and
confidentiality or that subjects are protected.
a. good manufacturing practice
b. good clinical practice
c. good laboratory practice
d. good pharmacovigilance practice - ✔✔b. good clinical practice
✔✔A person, who is independent of the trial, who cannot be unfairly influenced by
people involved with the trial, who attends the informed consent process if the subject or
the subject's legally acceptable representative cannot read, and who reads the informed
consent form and any other written information supplied to the subject.
a. impartial witness
b. trial subject
c. sub-investigator - ✔✔a. impartial witness
✔✔A committee that may be established by the sponsor to assess at intervals the
progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to
recommend to the sponsor whether to continue, modify, or stop a trial. -
✔✔Independent Data Monitoring Committee
, ✔✔An independent body constituted of a medical, scientific, and non-scientific
members, whose responsibility is to ensure the protection of the rights, safety and well-
being of human subjects involved in a trial by, among other things, reviewing,
approving, and providing continuing review of trial protocol and amendments and of the
methods and material to be used in obtaining and documenting informed consent of the
trial subjects. - ✔✔Institutional Review Board
✔✔The act of overseeing the progress of a clinical trial, and of ensuring that it is
conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and
the applicable regulatory requirements. - ✔✔Monitoring
✔✔A written, dated, and signed agreement between two or more involved parties that
sets out any arrangements on delegation and distribution of tasks and obligations and, if
appropriate, on financial matters. - ✔✔Contract
✔✔Detailed, written instructions to achieve uniformity of the performance of a specific
function. - ✔✔Standard Operating Procedures
✔✔A systemic and independent examination of trial related activities and documents to
determine whether the evaluated trial related activities were conducted, and the data
were recorded, analyzed and accurately reported according to the protocol, sponsor's
SOPs, GCP, and the applicable regulatory requirements. - ✔✔Audit
✔✔A person or an organization (commercial, academic, or other) hired by the sponsor
to perform one or more of a sponsor's trial-related duties and functions. - ✔✔Contract
Research Organization
✔✔A printed, optical, or electronic document designed to record all of the protocol
required information to be reported to the sponsor on each trial subject. - ✔✔Case
Report Form
✔✔A compilation of the clinical and nonclinical data on the investigational product which
is relevant to the study of the investigational product in human subjects. -
✔✔Investigator's Brochure
✔✔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
