ACRP CCRC EXAM PREP
Adverse Drug Reaction (ADR) - ANSIn the pre-approval clinical experience with a new
medicinal product or its new usages, particularly as the therapeutic dose(s) may not be
established: all noxious and unintended responses to a medicinal product related to any
dose should be considered adverse drug reactions.
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.
Applicable Regulatory Requirement(s) - ANSAny law(s) and regulation(s) addressing the
conduct of clinical trials of investigational products.
Approval (in relation to Institutional Review Boards) - ANSThe affirmative decision of the IRB
that the clinical trial has been reviewed and may be conducted at the institution site within
the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the
applicable regulatory requirements.
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 Certificate - ANSA declaration of confirmation by the auditor that an audit has taken
place.
Audit Report - ANSA written evaluation by the sponsor's auditor of the results of the audit.
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(s).
Single-blinding - ANSusually refers to the subject(s) being unaware
Double- blinding - ANSusually refers to the subject(s), investigator(s), monitor, and, in some
cases, data analyst(s) being unaware of the treatment assignment(s).
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 analyses are fully integrated into a single report
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.
Confidentiality - ANSPrevention of disclosure, to other than authorized individuals, of a
sponsor's proprietary information or of a subject's identity.
Contract - ANSA 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.
Coordinating Committee - ANSA committee that a sponsor may organize to coordinate the
conduct of a multicentre trial.
Coordinating Investigator - ANSAn investigator assigned the responsibility for the
coordination of investigators at different centres participating in a multicentre trial.
Contract Research Organization (CRO) - ANSA person or an organization (commercial,
academic, or other) contracted by the sponsor to perform one or more of a sponsor's
trial-related duties and functions.
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.
Adverse Drug Reaction (ADR) - ANSIn the pre-approval clinical experience with a new
medicinal product or its new usages, particularly as the therapeutic dose(s) may not be
established: all noxious and unintended responses to a medicinal product related to any
dose should be considered adverse drug reactions.
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.
Applicable Regulatory Requirement(s) - ANSAny law(s) and regulation(s) addressing the
conduct of clinical trials of investigational products.
Approval (in relation to Institutional Review Boards) - ANSThe affirmative decision of the IRB
that the clinical trial has been reviewed and may be conducted at the institution site within
the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the
applicable regulatory requirements.
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 Certificate - ANSA declaration of confirmation by the auditor that an audit has taken
place.
Audit Report - ANSA written evaluation by the sponsor's auditor of the results of the audit.
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(s).
Single-blinding - ANSusually refers to the subject(s) being unaware
Double- blinding - ANSusually refers to the subject(s), investigator(s), monitor, and, in some
cases, data analyst(s) being unaware of the treatment assignment(s).
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 analyses are fully integrated into a single report
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.
Confidentiality - ANSPrevention of disclosure, to other than authorized individuals, of a
sponsor's proprietary information or of a subject's identity.
Contract - ANSA 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.
Coordinating Committee - ANSA committee that a sponsor may organize to coordinate the
conduct of a multicentre trial.
Coordinating Investigator - ANSAn investigator assigned the responsibility for the
coordination of investigators at different centres participating in a multicentre trial.
Contract Research Organization (CRO) - ANSA person or an organization (commercial,
academic, or other) contracted by the sponsor to perform one or more of a sponsor's
trial-related duties and functions.
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.
