Good clinical practice
Adverse Drug Reaction (ADR) - ANS - all noxious (harmful) and unintended
responses to a medicinal product
Adverse Drug Reaction (ADR) Regarding marketed medicinal products - ANS -
normally used in man for prophylaxis, diagnosis, or therapy of diseases or for
modification of physiological function
Adverse Event (AE) - ANS - any unfavourable and unintended sign (including an
abnormal laboratory finding), symptom, or disease temporally associated with the use of
a medicinal (investigational) product, whether or not related to the medicinal
(investigational) product
Audit - ANS - 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).
Blinding/Masking - ANS - A procedure in which one or more parties to the trial are
kept unaware of the treatment assignment(s)
Case Report Form (CRF) - ANS - 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 - 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
Comparator (Product) - ANS - An investigational or marketed product (i.e., active
control), or placebo, used as a reference in a clinical trial.
Adverse Drug Reaction (ADR) - ANS - all noxious (harmful) and unintended
responses to a medicinal product
Adverse Drug Reaction (ADR) Regarding marketed medicinal products - ANS -
normally used in man for prophylaxis, diagnosis, or therapy of diseases or for
modification of physiological function
Adverse Event (AE) - ANS - any unfavourable and unintended sign (including an
abnormal laboratory finding), symptom, or disease temporally associated with the use of
a medicinal (investigational) product, whether or not related to the medicinal
(investigational) product
Audit - ANS - 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).
Blinding/Masking - ANS - A procedure in which one or more parties to the trial are
kept unaware of the treatment assignment(s)
Case Report Form (CRF) - ANS - 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 - 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
Comparator (Product) - ANS - An investigational or marketed product (i.e., active
control), or placebo, used as a reference in a clinical trial.
