Good Clinical Practice (GCP) is an internationally recognized quality standard. GCP standards include ethical, scientific and practical requirements in which all clinical research is conducted.
The primary principal of GCP is to ensure that the rights, safety and well-being of clinical trial subjects are protected in every aspect of medical research studies.
Work conducted in accordance with GCP ensures that sample analysis or evaluation, in a clinical trial study, provides reliable data for the provision of regulatory submissions. For quantitative image analysis data to be included in a data package submitted to regulatory authorities, it must be generated using a workflow that is fully compliant with GCP principles.