The use the words “dispensation” or “dispensing” to refer to the provision of a prepared dose of an
identified medication to the subject is not recommended in order to avoid possible misunderstandings
and confusion. This operation is more properly defined as administration. Administration includes directly
introducing the medication into or onto the individual’s body.
The process for IMP administration to the subjects should be described in an SOP.
The documentation generated at the time of IMP administration to the subjects should indicate
unequivocally the identity of the product administered to each subject, except in the case of a blinded
trial. Several possibilities exist to document this administration adequately:
use of a tear-off label, to be stuck on the case report form (CRF) at the time of IMP administration.
This ensures confidence that each subject indeed received the IMP that was packaged for him. An
appropriate documentation of the packaging operations is of the utmost importance;
documentation of the identity of the IMP directly in the CRF at the time of IMP administration. If
this information is read directly from the label on the IMP container an appropriate documentation
of the packaging operations is of the utmost importance. If there is a physical difference between
the test and the reference product (e.g. difference in pharmaceutical formulation, colour, shape,
markings) it is recommended to record this physical characteristic in the CRF at the time of
administration. The subject might be asked to sign a statement with a description of the IMP he is
given, in a language understandable to him. If the documentation on the packaging is insufficient
this physical characteristic should be used to check the identity of the product administered
against the randomisation list. This check should be documented at the time of administration.
The number of IMP units administered to each subject should be documented at the time of
administration.
Compliance with the requirements of the protocol regarding the conditions of administration should be
documented: volume of water taken with the IMP, administration in the fed or fasted state, posture etc.
