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Term Definition
Sender The person or entity creating the message for transmission.
Although the reporter and sender may be the same person, the
function of the sender should not be confused with that of the
reporter.[ICH E2B(R2)]
Serious Adverse Reaction
or Serious Adverse Drug
Reaction
Any untoward medical occurrence that at any dose:
-results in death,
-is life-threatening,
-requires inpatient hospitalization or prolongation of existing
hospitalization,
-results in persistent or significant disability/incapacity,
or
-is a congenital anomaly/birth defect
(see the ICH Guideline for Clinical Safety Data Management:
Definitions and Standards for Expedited Reporting).[ICH
E6(R1)]
Sponsor An individual, company, institution, or organization which takes
responsibility for the initiation, management, and/or financing of
a clinical trial. [ICH E6(R1) &E2F]
Spontaneous Reporting An unsolicited communication to a company, regulatory
authority or other organisation that describes an adverse drug
reaction in a patient given one or more medicinal products and
which does not derive from a study or any organized data
collection scheme.[ICH E2C(R1)]
Standard A technical specification which addresses a business
requirement, has been implemented in viable commercial
products, and, to the extent practical, complies with recognised
standards organisations such as ISO.
Use Case A description of a system's behaviour as it responds to a request
that originates from outside of that system.[Objectory AB]