Good Clinical Practice (GCP) is an internationally recognized ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials that involve human subjects. It provides a unified standard to ensure the rights, safety, and well-being of trial participants are protected, consistent with the principles originating from the Declaration of Helsinki. Adherence to GCP provides public assurance that the data and reported results are credible and accurate.
For the pharmaceutical and biotech industries, GCP compliance is mandatory for all trials intended for submission to regulatory authorities like the FDA, EMA, or Swissmedic. Key aspects covered by the guidelines include the roles and responsibilities of the investigator (the physician leading the study), the sponsor (the company funding the study), and the Institutional Review Board (IRB) or Ethics Committee. Core principles emphasize obtaining informed consent from participants, ensuring rigorous data quality through Source Data Verification, and maintaining comprehensive documentation, forming the basis for Clinical Trial validity and approval.
