From Wikipedia,
the free encyclopedia
Standard Operating
Procedures are sets of
instructions having the force of a
directive, covering those features
of operations which lend
themselves to a definite or
standardized procedure without
loss of effectiveness.
Every good
quality system is based on its
Standard Operating Procedures
(SOPs). In clinical research, SOPs
are defined by the
International Conference on
Harmonisation, or ICH, as
“detailed, written instructions to
achieve uniformity of the
performance of a specific
function.” SOPs are necessary for
a
clinical
research organization –
whether it concerns a
pharmaceutical company, a sponsor,
a contract research organization,
an investigator site, an Ethics
Committee or any other party
involved in clinical research – to
achieve maximum safety and
efficiency of the performed
clinical research operations.
It is therefore a must that all
people and sites involved in
Clinical Studies (both at the
sponsor and at the investigative
sites) have appropriate SOPs in
place in order to conduct clinical
research and to assure compliance
with the current regulations. The
ICH GCP (Good
clinical practice) Step 5
Guideline (Section 3.2.2) also
suggests that an
Institutional Review Board
have their own SOPs or written
standard procedures. This itself
proves that presence of SOPs are
an integral part of the
Clinical trial at all levels.
The presence of these quality
documents is essential when
inspections take place since the
most frequent reported
deficiencies during inspections
are the lack of written SOPs
and/or the failure to adhere to
them. The risk of GCP
non-compliance is high at
organizations with a poor
availability of clinical research
specific SOPs and also if at all
they are available the staff or
the people for whom they were
written are not either aware of
them or their need.
It therefore becomes very
important for the staff to train
them on these SOPs so that they
are actually aware of why and how
SOPs can play important role in
fulfilling the ICH and other
regulatory requirements. This
article will cover the importance
and value of SOPs, as well as
present an approach for the
development and training of SOPs
at staff levels.
See also
References
