ACRP CCRC LATEST 2026 EXAMINATION TEST QUESTIONS
AND ANSWERS GRADED A+
✔✔Clinical Trial/Study Report - ✔✔A written description of a trial/study of any
therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the
clinical and statistical description, presentations, and analyses are fully integrated into a
single report
✔✔Comparator (Product) - ✔✔An investigational or marketed product (i.e. active
control), or placebo, used as a reference in a clinical trial
✔✔Compliance (in relation to trials) - ✔✔Adherence to all the trial-related requirements,
GCP requirements, and the applicable regulatory requirements
✔✔Confidentiality - ✔✔Prevention of disclosure, to other than authorized individuals, of
a sponsor's proprietary informaion or of a subject's identity
✔✔Contract - ✔✔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
- the protocol may serve as the basis of a contract
✔✔Coordinating Committee - ✔✔A committee that a sponsor may organize to
coordinate the conduct of a multicentre trial
✔✔Coordinating Investigator - ✔✔An investigator assigned the responsibility for the
coordination of investigators at different centres participating in a multicentre trial
✔✔Contract Research Organization (CRO) - ✔✔A person or an organization contracted
by the sponsor to perform one or more of a sponsor's trial-related duties and functions
✔✔Direct Access - ✔✔Permission to examine, analyze, verify, and reproduce any
records and reports that are important to the evaluation of a clinical trial
- any party with direct access should take all reasonable precautions within the
constraints of the applicable regulatory requirements to maintain the confidentiality of
the subject's identities and the sponsor's proprietary information
✔✔Documentation - ✔✔All records, in any form, that descrvibe or record the methods,
conduct, and/or results of a trial, the factors affecting a trial, and the actions taken
✔✔Essential Documents - ✔✔Documents which individually and collectively permit
evaluation of the conduct of a study and the quality of the data produced (see 8.
Essential Documents for the Conduct of a Clinical Trial).
, ✔✔Independent Data-Monitoring Committee (IDMC) (Data and Safety Monitoring
Board, Monitoring Committee, Data Monitoring Committee) - ✔✔An independent data-
monitoring 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.
✔✔Impartial Witness - ✔✔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.
✔✔Independent Ethics Committee (IEC) - ✔✔An independent body (a review board or
a committee, institutional, regional, national, or supranational), constituted of medical
professionals and non-medical members, whose responsibility it is to ensure the
protection of the rights, safety and well-being of human subjects involved in a trial and
to provide public assurance of that protection, by, among other things, reviewing and
approving/providing favourable opinion on, the trial protocol, the suitability of the
investigator(s), facilities, and the methods and material to be used in obtaining and
documenting informed consent of the trial subjects.
The legal status, composition, function, operations and regulatory requirements
pertaining to Independent Ethics Committees may differ among countries, but should
allow the Independent Ethics Committee to act in agreement with GCP as described in
this guideline.
✔✔Informed Consent - ✔✔A process by which a subject voluntarily confirms his or her
willingness to participate in a particular trial, after having been informed of all aspects of
the trial that are relevant to the subject's decision to participate.
- documented by means of a written, signed and dated informed consent form.
✔✔Inspection - ✔✔The act by a regulatory authority(ies) of conducting an official review
of documents, facilities, records, and any other resources that are deemed by the
authority(ies) to be related to the clinical trial and that may be located at the site of the
trial, at the sponsor's and/or contract research organization's (CRO's) facilities, or at
other establishments deemed appropriate by the regulatory authority(ies).
✔✔Institution (medical) - ✔✔Any public or private entity or agency or medical or dental
facility where clinical trials are conducted.
✔✔Institutional Review Board (IRB) - ✔✔An independent body constituted of 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
AND ANSWERS GRADED A+
✔✔Clinical Trial/Study Report - ✔✔A written description of a trial/study of any
therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the
clinical and statistical description, presentations, and analyses are fully integrated into a
single report
✔✔Comparator (Product) - ✔✔An investigational or marketed product (i.e. active
control), or placebo, used as a reference in a clinical trial
✔✔Compliance (in relation to trials) - ✔✔Adherence to all the trial-related requirements,
GCP requirements, and the applicable regulatory requirements
✔✔Confidentiality - ✔✔Prevention of disclosure, to other than authorized individuals, of
a sponsor's proprietary informaion or of a subject's identity
✔✔Contract - ✔✔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
- the protocol may serve as the basis of a contract
✔✔Coordinating Committee - ✔✔A committee that a sponsor may organize to
coordinate the conduct of a multicentre trial
✔✔Coordinating Investigator - ✔✔An investigator assigned the responsibility for the
coordination of investigators at different centres participating in a multicentre trial
✔✔Contract Research Organization (CRO) - ✔✔A person or an organization contracted
by the sponsor to perform one or more of a sponsor's trial-related duties and functions
✔✔Direct Access - ✔✔Permission to examine, analyze, verify, and reproduce any
records and reports that are important to the evaluation of a clinical trial
- any party with direct access should take all reasonable precautions within the
constraints of the applicable regulatory requirements to maintain the confidentiality of
the subject's identities and the sponsor's proprietary information
✔✔Documentation - ✔✔All records, in any form, that descrvibe or record the methods,
conduct, and/or results of a trial, the factors affecting a trial, and the actions taken
✔✔Essential Documents - ✔✔Documents which individually and collectively permit
evaluation of the conduct of a study and the quality of the data produced (see 8.
Essential Documents for the Conduct of a Clinical Trial).
, ✔✔Independent Data-Monitoring Committee (IDMC) (Data and Safety Monitoring
Board, Monitoring Committee, Data Monitoring Committee) - ✔✔An independent data-
monitoring 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.
✔✔Impartial Witness - ✔✔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.
✔✔Independent Ethics Committee (IEC) - ✔✔An independent body (a review board or
a committee, institutional, regional, national, or supranational), constituted of medical
professionals and non-medical members, whose responsibility it is to ensure the
protection of the rights, safety and well-being of human subjects involved in a trial and
to provide public assurance of that protection, by, among other things, reviewing and
approving/providing favourable opinion on, the trial protocol, the suitability of the
investigator(s), facilities, and the methods and material to be used in obtaining and
documenting informed consent of the trial subjects.
The legal status, composition, function, operations and regulatory requirements
pertaining to Independent Ethics Committees may differ among countries, but should
allow the Independent Ethics Committee to act in agreement with GCP as described in
this guideline.
✔✔Informed Consent - ✔✔A process by which a subject voluntarily confirms his or her
willingness to participate in a particular trial, after having been informed of all aspects of
the trial that are relevant to the subject's decision to participate.
- documented by means of a written, signed and dated informed consent form.
✔✔Inspection - ✔✔The act by a regulatory authority(ies) of conducting an official review
of documents, facilities, records, and any other resources that are deemed by the
authority(ies) to be related to the clinical trial and that may be located at the site of the
trial, at the sponsor's and/or contract research organization's (CRO's) facilities, or at
other establishments deemed appropriate by the regulatory authority(ies).
✔✔Institution (medical) - ✔✔Any public or private entity or agency or medical or dental
facility where clinical trials are conducted.
✔✔Institutional Review Board (IRB) - ✔✔An independent body constituted of 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
