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In this presentation,
I'm going to cover
the responsibilities of
key personnel involved in
non-clinical GLP safety studies.
My name is David Long.
I am the director of a
consulting company called
Long and Associates International
Consultancy Limited (LAIC).
I have been involved in
GLP since the late 1970s.
I have a good deal
of experience in
the implementation and
maintenance of GLP systems.
As for any quality
management system,
GLP puts great emphasis
on personnel and
the way in which
the role of each actor,
from management to technician,
should be performed.
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In this presentation,
I will attempt to answer the
following two questions:
First, what roles and
responsibilities
are defined in GLP?
Second, how should these roles
and responsibilities
be documented?
I will concentrate
what I have to say
on the key personnel.
But all personnel working on
non-clinical safety
studies under GLP
should be aware that
they have responsibilities for
the way in which they
perform their tasks,
and in particular,
for the integrity and
accuracy of data generated
during the study.
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I have used the OECD
GLP principles and
the various consensus
documents and
advisory documents
made available by
the OECD to summarize
the roles and responsibilities
of selected personnel.
I will deal, in turn,
with the following:
Sponsor, facility
management, study director,
principal investigator,
archivist, and quality assurance.
Some of these functions
have been given
wider coverage in other
talks in this GLP series.
We will start by looking at
the sponsor's responsibilities.
Commissioning a study
