What is GCP? Good Clinical Practice (GCP) is an international quality standard for conducting clinical trials that is provided by the International Conference on Harmonization (ICH), an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects. 13 Principles of Good Clinical Practice 0 Ethics Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement (s). 0 Trial risk vs trial benefit What is Good Clinical Practice? Good Clinical Practice, also known as GCP, is an international set of standards designed to protect patients and ensure the integrity of clinical trials. These regulations are aimed at scientific studies that gather evidence to support the safety and effectiveness of certain investigational drugs for humans and Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical trials that involve people. ICH E6 (R2) Good clinical practice - Scientific guideline. This document addresses the good clinical practice, an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. .

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