ACRP-CP Exam Review
Adverse Drug Reaction (ADR) - ANSAll noxious and unintended responses to a medicinal
product related to any dose (causal relationship is at least a reasonable possibility).
Regarding marketed medicinal products: a response to a drug which is noxious and
unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or
therapy of diseases or for modification of physiological function
Adverse Event (AE) - ANSAny 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. (ICH GCP E6 1.2)
Audit - ANSA systematic 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 standard operating procedures (SOPs), Good Clinical Practice (GCP), and the
applicable regulatory requirement(s).
Audit Trail - ANSDocumentation that allows reconstruction of the course of events.
Blinding/Masking - ANSA procedure in which one or more parties to the trial are kept
unaware of the treatment assignment. Single-blinding usually refers to the subject(s) being
unaware, and double- blinding usually refers to the subject(s), investigator(s), monitor, and,
in some cases, data analyst(s) being unaware of the treatment assignment(s). (ICH GCP E6
1.10)
Case Report Form (CRF) - ANSA printed, optical, or electronic document designed to record
all of the protocol required information to be reported to the sponsor on each trial subject.
Clinical Trial/Study - ANSAny investigation in human subjects intended to discover or verify
the clinical, pharmacological and/or other pharmacodynamic effects of an investigational
product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to
study absorption, distribution, metabolism, and excretion of an investigational product(s) with
the object of ascertaining its safety and/or efficacy.
Clinical Trial/Study Report - ANSA 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 analysis are fully integrated into a single report.
(ICH GCP E6 1.13)
Comparator (Product) - ANSAn investigational or marketed product (i.e., active control), or
placebo, used as a reference in a clinical trial.
Compliance (in relation to trials) - ANSAdherence to all the trial-related requirements, Good
Clinical Practice (GCP) requirements, and the applicable regulatory requirements.
Direct Access - ANSPermission to examine, analyze, verify, and reproduce any records and
reports that are important to evaluation of a clinical trial.
Documentation - ANSAll records, in any form (including, but not limited to, written, electronic,
magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or
record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the
actions taken.
Essential Documents - ANSDocuments which individually and collectively permit evaluation
of the conduct of a study and the quality of the data produced.
, Good Clinical Practice (GCP) - ANSA standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and reporting of clinical trials that provides
assurance that the data and reported results are credible and accurate, and that the rights,
integrity, and confidentiality of trial subjects are protected.
Impartial Witness - ANSA 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.
Informed Consent - ANSA 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. Informed consent is documented
by means of a written, signed and dated informed consent form.
Inspection - ANSThe 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).
Institutional Review Board (IRB) - ANSAn 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 amendments and
of the methods and material to be used in obtaining and documenting informed consent of
the trial subjects.
Investigational Product - ANSA pharmaceutical form of an active ingredient or placebo being
tested or used as a reference in a clinical trial, including 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 - ANSA 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's Brochure - ANSA 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 - ANSAn 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 - ANSThe act of overseeing the progress of a clinical trial, and of ensuring that it
is conducted, recorded, and reported in accordance with the protocol, Standard Operating
Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory
requirement(s).
Nonclinical Study - ANSBiomedical studies not performed on human subjects.
Protocol - ANSA document that describes the objective(s), design, methodology, statistical
considerations, and organization of a trial. Usually also gives the background and rationale
for the trial, but these could be provided in other documents.
Quality Assurance (QA) - ANSAll those planned and systematic actions that are established
to ensure that the trial is performed and the data are generated, documented (recorded), and
Adverse Drug Reaction (ADR) - ANSAll noxious and unintended responses to a medicinal
product related to any dose (causal relationship is at least a reasonable possibility).
Regarding marketed medicinal products: a response to a drug which is noxious and
unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or
therapy of diseases or for modification of physiological function
Adverse Event (AE) - ANSAny 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. (ICH GCP E6 1.2)
Audit - ANSA systematic 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 standard operating procedures (SOPs), Good Clinical Practice (GCP), and the
applicable regulatory requirement(s).
Audit Trail - ANSDocumentation that allows reconstruction of the course of events.
Blinding/Masking - ANSA procedure in which one or more parties to the trial are kept
unaware of the treatment assignment. Single-blinding usually refers to the subject(s) being
unaware, and double- blinding usually refers to the subject(s), investigator(s), monitor, and,
in some cases, data analyst(s) being unaware of the treatment assignment(s). (ICH GCP E6
1.10)
Case Report Form (CRF) - ANSA printed, optical, or electronic document designed to record
all of the protocol required information to be reported to the sponsor on each trial subject.
Clinical Trial/Study - ANSAny investigation in human subjects intended to discover or verify
the clinical, pharmacological and/or other pharmacodynamic effects of an investigational
product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to
study absorption, distribution, metabolism, and excretion of an investigational product(s) with
the object of ascertaining its safety and/or efficacy.
Clinical Trial/Study Report - ANSA 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 analysis are fully integrated into a single report.
(ICH GCP E6 1.13)
Comparator (Product) - ANSAn investigational or marketed product (i.e., active control), or
placebo, used as a reference in a clinical trial.
Compliance (in relation to trials) - ANSAdherence to all the trial-related requirements, Good
Clinical Practice (GCP) requirements, and the applicable regulatory requirements.
Direct Access - ANSPermission to examine, analyze, verify, and reproduce any records and
reports that are important to evaluation of a clinical trial.
Documentation - ANSAll records, in any form (including, but not limited to, written, electronic,
magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or
record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the
actions taken.
Essential Documents - ANSDocuments which individually and collectively permit evaluation
of the conduct of a study and the quality of the data produced.
, Good Clinical Practice (GCP) - ANSA standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and reporting of clinical trials that provides
assurance that the data and reported results are credible and accurate, and that the rights,
integrity, and confidentiality of trial subjects are protected.
Impartial Witness - ANSA 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.
Informed Consent - ANSA 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. Informed consent is documented
by means of a written, signed and dated informed consent form.
Inspection - ANSThe 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).
Institutional Review Board (IRB) - ANSAn 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 amendments and
of the methods and material to be used in obtaining and documenting informed consent of
the trial subjects.
Investigational Product - ANSA pharmaceutical form of an active ingredient or placebo being
tested or used as a reference in a clinical trial, including 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 - ANSA 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's Brochure - ANSA 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 - ANSAn 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 - ANSThe act of overseeing the progress of a clinical trial, and of ensuring that it
is conducted, recorded, and reported in accordance with the protocol, Standard Operating
Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory
requirement(s).
Nonclinical Study - ANSBiomedical studies not performed on human subjects.
Protocol - ANSA document that describes the objective(s), design, methodology, statistical
considerations, and organization of a trial. Usually also gives the background and rationale
for the trial, but these could be provided in other documents.
Quality Assurance (QA) - ANSAll those planned and systematic actions that are established
to ensure that the trial is performed and the data are generated, documented (recorded), and
