Need for Qualified Audit Teams
An integral part of modules in clinical
research courses focus on the ethical
standards that have to be implemented without compromising the quality of trial
results. This necessitates the establishment of a good quality assurance team
that will be able to deliver excellent outputs to the various project sponsors
by focusing on Good Clinical Practice guidelines as per global standards.
Importance of Quality
Assurance in Clinical Trials
It is essential for the audit
teams to not overlook the aspect of quality assurance in the field of clinical research.
The first reason being that the sponsor would experience major losses if there
is either a delay in project development or getting inadequate results. Also,
the effects would be detrimental as there could be legal issues as well as
impact on human health.
Incorporation of Good Clinical
Practices for enhanced clinical trials
The Good Clinical practices makes
certain that the design, implementation, monitoring, auditing, recording,
reporting and analysis of clinical trails are managed in a better manner
Good Practices Followed
in Clinical Trials
There are
numerous Quality Assurance -focused good practices followed by Clinical
Research Organizations (CRO’s) in clinical trials. They are:
Ø Assimilation of Quality Culture in Audit Teams
If a set of shared, accepted and
integrated pattern of quality are assimilated in the project personnel, then
members handling different responsibilities will ensure that they achieve
quality parameters. Moreover, the professionals would work together as one unit
to implement quality assurance. Therefore, OA analysts will be at ease to
deliver higher number of quality trials
Ø Implementing Quality in Design
Both the project sponsor and the
clinical research Organization should collaborate and design the project in
such a manner that each stage of the process has a component for quality checks
of the trials. Furthermore, several Quality Checks should be conducted
regularly such that errors should not be overlooked. The reason being that the
longer it would take to discover the error; there are more chances of
detrimental effects on the safety and efficacy analysis of the clinical trial.
Respecting the Subjects
Involved in Clinical Trials
It is an irrefutable fact that
clinical trials are conducted after the subjects meet specific parameters for
ensuring their suitability in trial participation. However, the quality
assurance for clinical trials also takes up the responsibility to acquire
subjects that are in compliance with the protocol for the project. Nevertheless
these subjects have to be treated with utmost respect and should be treated
within the limits of ethics.
Audit Teams ensure
compliance of guidelines
Most importantly, clinical
trials, audit teams run audits for protocols, SOPs, guidelines for Good Clinical Practices and
other nation-specific guidelines. Therefore,
it is the duty of the audit team to run internal audits during the drug
development process in order to review documented trial data.
In conclusion, the audit team
plays an integral part in implementing quality assurance in the field of
clinical research from the initial stage to the final stage. These audits
assist the project team member’s to evaluate the entire clinical trial, rectify
issues on timely basis and enhance the processes for further trials.
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