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This document provides a unified standard for the ICH regions for clinical trials involving human subjects. It covers topics such as ethics, trial design, safety reporting, informed consent, statistics and innovation.
- Good clinical practice - European Medicines Agency (EMA)
Good clinical practice (GCP) is an international ethical and...
- Good clinical practice - European Medicines Agency (EMA)
Learn about the international ethical and scientific quality standard for clinical trials involving human subjects, and how it is implemented and coordinated in the EU. Find guidance, inspections, Q&A and COVID-19 related information on GCP.
This document is a work-in-progress version of the updated principles of GCP for clinical trials, under development by the ICH E6(R3) Expert Working Group. It aims to provide flexible and applicable guidance for trial design, conduct, and quality, aligned with ICH E8 and other ICH guidelines.
This document is a consensus guideline for the conduct of clinical trials on pharmaceuticals for human use, developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It covers the principles, responsibilities, procedures and records of IRB/IEC, investigator, sponsor and regulatory authority, as well as the annexes and glossary.
19 Απρ 2021 · The ICH E6 (R3) Expert Working Group is updating the principles of GCP, which are widely used by clinical trial researchers and have a significant impact on trial participants and patients. The draft version of the principles is available on the ICH Guideline page and a global web conference will be held in May 2021.
This document is an integrated addendum to the ICH E6(R1) guideline for good clinical practice (GCP) in clinical trials of investigational products. It provides the principles, responsibilities and procedures of GCP for sponsors, investigators, IRB/IECs and trial subjects.
9 Νοε 2023 · This document provides a unified standard for GCP, an ethical and scientific quality standard for clinical trials involving human subjects. It aims to facilitate the mutual acceptance of clinical data by the regulatory authorities in the EU, Japan, and the US.
