GCP Definitions

GCP Compliance (Clinical Trials)

Definitions:

Good Clinical Practice: Good clinical practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible (as per Article 1.2 of 2001/20/EC )

Good Clinical Practice: A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. (as per Section 1.27 of ICH E6 )

GCP Compliance (Clinical Trials)