Purpose & main areas covered of GCP in one slide

1. Main areas covered
There many activities covered by GCP include
trial design, definition of scientifically and
ethically sound trial objectives, oversight of trial
activities, data collection and quality assurance,
study analysis, and human subject protections.
All of these activities are intended to support
clinical research, with the ultimate goals of
improving the health and welfare of patients
and advancing biomedical science.
GOOD CLINICAL PRACTICE (GCP) is a set of internationally-recognized ethical
and scientific quality requirements that must be followed when designing, conducting,
recording and reporting clinical trials that involved people. It is set by ICH (International
Conference on Harmonisation), an international body that defines the standards.
Purpose
• To protect the rights, safety and welfare of
human participating in research
• To assure the quality, reliability and
integrity of data collected
• To provide standards and guidelines for
the conduct of clinical research
• To speeds up marketing of new drugs and
decreases the cost to sponsors and to the
public