GCP – Clinical
GCP (Good Clinical Practices) refers to the international ethical analysis, and scientific quality standard for designing, conducting and auditing clinical trials that involve the participation of human test subjects.
How does it work?
GCP (Good Clinical Practices) provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are respected and protected.
Therefore, the GCP audit is the interface for this assurance.
The audit will assess compliance with regulatory requirements for the clinical trial protocol and the clinical quality management plan (CQMP) by the principal investigator and all the site support personnel.