ICH Harmonised Guideline for Good
Clinical Practice E6
- ANS -
- ANS -
adverse drug reaction - ANS - all noxious and unintended responses to a medicinal
product related to any dose should be considered adverse drug reactions. Causal
relationship must be at least a reading possibility i.e. the relationship cannot be ruled
out
Adverse Event (AE) - ANS - 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.
ALCOA - ANS - Attributable, Legible, Contemporaneous, Original, Accurate, and
Complete
Audit - ANS - A 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), GCP, and the applicable
regulatory requirements.
Audit Certificate - ANS - A declaration of confirmation by the auditor that an audit has
taken place.
Audit Report - ANS - A written evaluation by the sponsor's auditor of the results of the
audit.
Audit Trail - ANS - Documentation that allows reconstruction of the course of events.
Blinding/Masking - ANS - A procedure in which one or more parties to the trial are kept
unaware of the treatment assignment.
, Case report form (CRF) - ANS - 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.
Certified Copy - ANS - A copy of the original record that has been verified (i.e. by a
dated signature or by generation through a validated process) to have the same
information, including data that describe the context, content. and structure, as the
original.
Clinical trial/study - ANS - Any 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 - ANS - 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 analysis are fully integrated into a
single report. (ICH GCP E6 1.13)
Comparator (product) - ANS - An investigational or marketed product (i.e., active
control), or placebo, used as a reference in a clinical trial.
Compliance - ANS - Adherence to all trial-related requirements, good clinical practice
requirements, and the applicable regulatory requirements
Confidentiality - ANS - Prevention of disclosure, to other than authorized individuals, of
the sponsors proprietary information or off a subject's identity
Contract - ANS - A written, dated, signed agreement between 2 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.
Contract research organization (CRO) - ANS - A 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.
Clinical Practice E6
- ANS -
- ANS -
adverse drug reaction - ANS - all noxious and unintended responses to a medicinal
product related to any dose should be considered adverse drug reactions. Causal
relationship must be at least a reading possibility i.e. the relationship cannot be ruled
out
Adverse Event (AE) - ANS - 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.
ALCOA - ANS - Attributable, Legible, Contemporaneous, Original, Accurate, and
Complete
Audit - ANS - A 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), GCP, and the applicable
regulatory requirements.
Audit Certificate - ANS - A declaration of confirmation by the auditor that an audit has
taken place.
Audit Report - ANS - A written evaluation by the sponsor's auditor of the results of the
audit.
Audit Trail - ANS - Documentation that allows reconstruction of the course of events.
Blinding/Masking - ANS - A procedure in which one or more parties to the trial are kept
unaware of the treatment assignment.
, Case report form (CRF) - ANS - 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.
Certified Copy - ANS - A copy of the original record that has been verified (i.e. by a
dated signature or by generation through a validated process) to have the same
information, including data that describe the context, content. and structure, as the
original.
Clinical trial/study - ANS - Any 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 - ANS - 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 analysis are fully integrated into a
single report. (ICH GCP E6 1.13)
Comparator (product) - ANS - An investigational or marketed product (i.e., active
control), or placebo, used as a reference in a clinical trial.
Compliance - ANS - Adherence to all trial-related requirements, good clinical practice
requirements, and the applicable regulatory requirements
Confidentiality - ANS - Prevention of disclosure, to other than authorized individuals, of
the sponsors proprietary information or off a subject's identity
Contract - ANS - A written, dated, signed agreement between 2 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.
Contract research organization (CRO) - ANS - A 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.
