Good Clinical Practices (GCPs) are international ethical and scientific quality standards for the design, conduct, performance, monitoring, auditing, analysis, reporting and regulation of human clinical investigations…
Clinical investigations are experiments and studies in which a medical product such as a drug or device is administered or dispensed to, or used involving, one or more human subjects. Documentation of compliance with GCP standards is required for clinical investigations submissions to the regulatory agencies in USA, Europe, Japan and Canada. These standards provide assurance that the rights and confidentiality of the trial subjects are protected and that the data and reported results are credible and accurate.
Compliance with clinical investigations registration standards provide public assurance that the rights, safety, and wellness of human subjects are followed and protected.
ICH (Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) GCP guidance objective is to provide a unified mutual standard for United States, the European Union (EU) and Japan for clinical data by the regulatory authorities in these jurisdictions.
The guidance was developed considering the current best clinical practices of the United States, European Union, Japan, Australia, Canada, the Nordic countries, and the World Health Organization (WHO). ICH “efficacy” have many topics (E1 to E12A). ICH – E6 is relevant to Good Clinical Practice.