in Clinical Research
is responsible for implementing and maintaining quality assurance
and quality control systems with written Standard Operating Procedures
(SOPs) to ensure that trials are conducted and data are generated,
documented (recorded), and reported in compliance with the protocol,
GCP and the applicable regulatory requirement(s). As
per the ICH – GCP Guidelines, E.6, 5.1.1.
should be applicable to each stage of data handling to ensure
that all data are reliable and have been processed correctly.
As per the ICH – GCP Guidelines, E.6,
It will be helpful
initially to consider why terms relating to quality, quality systems
and audit are so important within the context of GCP.
For Public Health and Assurance: In order
to produce safe, effective and reliable medicines for use
by the public, it is clearly essential to have standards
that will ensure consistency in terms of their testing and
manufacture. The growth in consumer power is reflected in
public demand for quality systems to be in place and for
compliance with those systems to be evident.
obtain Marketing Authorization: The assessors of
marketing authorization applications for new medicines have
a duty of care to the public and therefore look for evidence
of quality to be provided in all submissions.
avoid Litigation: Increasingly, when a medicine
fails, public expectation is for investigation, compensation
and increased control. Litigation is costly to the pharmaceutical
industry both in financial terms and in terms of corporate
and individual reputations. The application of sound quality
systems can reduce the likelihood of failure and mitigate
the effects litigation.
To make research efficient and cost – effective:
Where quality systems are absent, there is an increased
likelihood that clinical research will follow false leads
and fail to recognize unproductive or even dangerous directions
in drug development. Clinical Research is costly and time-consuming,
and any reduction of unnecessary and unproductive activities
will inevitably enhance efficiently.
To increase pride in work: Most people
spend at least one third of their days in work-related activities
and would prefer to enjoy that time rather than experience
feelings of frustration and failure. It appears that individuals
wish, at least initially, to do a good job. However, many
of the problems arising at work serve to reduce the pleasure
that was originally anticipated. These problems often arise
because the system in which individuals are required to
perform does not adequately support their performance. Application
of quality standards such as those outlined in GCP provides
a safe framework within which workers can take pride in
their achievements and feed back suggestions to further
enhance the quality of their work.
does quality become an issue?
Quality is an issue
at all stages of clinical research, and the only successful approach
is to build in quality from the outset.
and training of staff
Although the old adage
that “You get what you pay for” can be taken too far,
it is a mistake for companies to try to conduct clinical research
at the expense of their staff. Staff in all functions need to
be appropriately qualified, experienced, trained and most of all,
motivated. Finance, however, is just one form of motivation. The
feeling of being appreciated and valued comes from many sources
and is nurtured when people are involved, respected and consulted.
Management must therefore take time to recruit well, invest in
ongoing training, establish a system of career development and
foster a feeling of involvement in order to retain loyal staff
and enhance their performance.
of quality systems for all activities:
Quality is cited as
Principle 13 in the ICH GCP guideline, but it could equally rank
as Principle 1, because it should be inherent in every aspect
of clinical research. What is required is a quality assurance
system characterized by standard (high quality) procedures, quality
control and audit, with appropriate feedback systems and a “no
to quality: a pervading culture:
Commitment is fundamental
to appropriate recruitment, training and systems maintenance.
Regrettably, many companies’ quality systems are led from
below, with experienced and motivated staff trying to pull management
into compliance with systems of which they have little awareness
and in which they have had only the most rudimentary training.
In the ideal corporate environment, commitment to GCP will be
emphasized at recruitment and reinforced at induction. All staff
in every function should understand the motivation behind the
quality system, in terms of ethics, safety, data quality and ultimate
job satisfaction. In a less-than-ideal environment, lip service
may be the reality.