Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of 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 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. 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. 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 Practices The Regulatory Operations and Enforcement Branch (ROEB) has the responsibility for the inspections and investigations of clinical trials. pKNAr.

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