Uploaded on Jul 30, 2020
Clinical match
What are Clinical Trails ??
Treatments and medicines are not given to the patients as soon as they
are prepared. They first need to be tested .Its a type of study that studies
or tests a treatment on people. This is basically to confirm the safety.
Good Clinical Practice(GCP) in Clinical Trials
One of the most important things in running a clinical trial is ensuring
that your participants’ safety remains a priority as the study progresses.
Good Clinical Practice(GCP) was put in place by the International
Conference on Harmonization (ICH)1 for FDA-regulated studies, with
the major aim of ensuring the participant’s wellbeing and safety all
through the trial.
What Does GCP Mean?
GCP is an international ethical and scientific quality standard for
designing and conducting clinical trials. It provides assurance regarding
the credibility and accuracy of the data and results, and that the rights
and confidentiality of the trial subjects are valued and protected2. The
world’s perspective about Good Clinical Practices was changed by the
Medicines for Human Use Regulations (2004)3 and the European
Union Directive on GCP4.
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