GOOD CLINICAL PRACTICE LATEST 2026 EXAM QUESTIONS
AND ANSWERS GRADED A+
✔✔Investigational Product - ✔✔A pharmaceutical form of an active ingredient or
placebo being tested or used as a reference in a
clinical trial.
A product with a marketing authorization when used or assembled (formulated or
packaged) in a way different from the approved form, or when used for an unapproved
indication, or when used to gain further information about an approved use.
✔✔Investigator - ✔✔A person responsible for the conduct of the clinical trial at a trial
site. If a trial is conducted by a team of individuals at a trial site, the investigator is the
responsible leader of the team and may be called the principal investigator.
✔✔Investigator / Institution - ✔✔An expression meaning "the investigator and/or
institution, where required by the applicable
regulatory requirements"
✔✔Investigator's Brochure - ✔✔A compilation of the clinical and nonclinical data on the
investigational product(s) which is relevant to the study of the investigational product(s)
in human subjects
✔✔Legally Acceptable Representative (LAR) - ✔✔An individual or juridical or other
body authorized under applicable law to consent, on behalf of a prospective subject, to
the subject's participation in the clinical trial.
✔✔Monitoring - ✔✔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 requirement(s).
✔✔Monitoring Report - ✔✔A written report from the monitor to the sponsor after each
site visit and/or other trial-related
communication according to the sponsorís SOPs
✔✔Multicentre Trial - ✔✔A clinical trial conducted according to a single protocol but at
more than one site, and therefore, carried out by more than one investigator.
✔✔Nonclinical Study - ✔✔Biomedical studies not performed on human subjects.
✔✔Opinion (in relation to Independent Ethics Committee) - ✔✔The judgement and/or
the advice provided by an Independent Ethics Committee (IEC).
✔✔Protocol - ✔✔A document that describes the objective(s), design, methodology,
statistical considerations, and organization of a trial. The protocol usually also gives the
, background and rationale for the trial, but these could be provided in other protocol
referenced documents.
✔✔Protocol Amendment - ✔✔A written description of a change(s) to or formal
clarification of a protocol.
✔✔Quality Assurance (QA) - ✔✔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
Good Clinical Practice (GCP) and the applicable regulatory requirement(s).
✔✔Quality Control (QC) - ✔✔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.
✔✔Randomization - ✔✔The process of assigning trial subjects to treatment or control
groups using an element of chance to determine the assignments in order to reduce
bias.
✔✔Regulatory Authorities - ✔✔Bodies having the power to regulate. Authorities that
review submitted clinical data and those that conduct
inspections.
✔✔Serious Adverse Event (SAE) or
Serious Adverse Drug Reaction (Serious ADR) - ✔✔Any untoward medical occurrence
that at any dose:
• results in death,
• is life-threatening,
• requires inpatient hospitalization or prolongation of existing hospitalization,
• results in persistent or significant disability/incapacity,
or
• is a congenital anomaly/birth defect
✔✔Source Data - ✔✔All information in original records and certified copies of original
records of clinical findings, observations, or other activities in a clinical trial necessary
for the reconstruction and evaluation of the trial. Source data are contained in source
documents (original records or certified copies).
✔✔Source Documents - ✔✔Original documents, data, and records (e.g., hospital
records, clinical and office charts, laboratory notes, memoranda.....
✔✔Sponsor - ✔✔An individual, company, institution, or organization which takes
responsibility for the initiation,
management, and/or financing of a clinical trial
AND ANSWERS GRADED A+
✔✔Investigational Product - ✔✔A pharmaceutical form of an active ingredient or
placebo being tested or used as a reference in a
clinical trial.
A product with a marketing authorization when used or assembled (formulated or
packaged) in a way different from the approved form, or when used for an unapproved
indication, or when used to gain further information about an approved use.
✔✔Investigator - ✔✔A person responsible for the conduct of the clinical trial at a trial
site. If a trial is conducted by a team of individuals at a trial site, the investigator is the
responsible leader of the team and may be called the principal investigator.
✔✔Investigator / Institution - ✔✔An expression meaning "the investigator and/or
institution, where required by the applicable
regulatory requirements"
✔✔Investigator's Brochure - ✔✔A compilation of the clinical and nonclinical data on the
investigational product(s) which is relevant to the study of the investigational product(s)
in human subjects
✔✔Legally Acceptable Representative (LAR) - ✔✔An individual or juridical or other
body authorized under applicable law to consent, on behalf of a prospective subject, to
the subject's participation in the clinical trial.
✔✔Monitoring - ✔✔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 requirement(s).
✔✔Monitoring Report - ✔✔A written report from the monitor to the sponsor after each
site visit and/or other trial-related
communication according to the sponsorís SOPs
✔✔Multicentre Trial - ✔✔A clinical trial conducted according to a single protocol but at
more than one site, and therefore, carried out by more than one investigator.
✔✔Nonclinical Study - ✔✔Biomedical studies not performed on human subjects.
✔✔Opinion (in relation to Independent Ethics Committee) - ✔✔The judgement and/or
the advice provided by an Independent Ethics Committee (IEC).
✔✔Protocol - ✔✔A document that describes the objective(s), design, methodology,
statistical considerations, and organization of a trial. The protocol usually also gives the
, background and rationale for the trial, but these could be provided in other protocol
referenced documents.
✔✔Protocol Amendment - ✔✔A written description of a change(s) to or formal
clarification of a protocol.
✔✔Quality Assurance (QA) - ✔✔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
Good Clinical Practice (GCP) and the applicable regulatory requirement(s).
✔✔Quality Control (QC) - ✔✔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.
✔✔Randomization - ✔✔The process of assigning trial subjects to treatment or control
groups using an element of chance to determine the assignments in order to reduce
bias.
✔✔Regulatory Authorities - ✔✔Bodies having the power to regulate. Authorities that
review submitted clinical data and those that conduct
inspections.
✔✔Serious Adverse Event (SAE) or
Serious Adverse Drug Reaction (Serious ADR) - ✔✔Any untoward medical occurrence
that at any dose:
• results in death,
• is life-threatening,
• requires inpatient hospitalization or prolongation of existing hospitalization,
• results in persistent or significant disability/incapacity,
or
• is a congenital anomaly/birth defect
✔✔Source Data - ✔✔All information in original records and certified copies of original
records of clinical findings, observations, or other activities in a clinical trial necessary
for the reconstruction and evaluation of the trial. Source data are contained in source
documents (original records or certified copies).
✔✔Source Documents - ✔✔Original documents, data, and records (e.g., hospital
records, clinical and office charts, laboratory notes, memoranda.....
✔✔Sponsor - ✔✔An individual, company, institution, or organization which takes
responsibility for the initiation,
management, and/or financing of a clinical trial
