PLICIB promotes the translation of the document ICH Guideline for Good Clinical Practice

PLICIB – the Lusophone Platform for Clinical Research and Biomedical Innovation has promoted the translation of the ICH E6(R3) Guideline for Good Clinical Practice (GCP) into Portuguese. This document is developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

The document ICH E6(R3) Guideline represents the third revision of the international guidance on Good Clinical Practice.

It sets out ethical and scientific standards for the design, conduct, recording, and reporting of clinical trials involving human participants, aiming to ensure both the protection of participants’ rights, safety and well-being, and the credibility and robustness of the data generated.

The main objectives of this guideline are:

• To ensure protection of participants in clinical trials;
• To guarantee the quality and reliability of collected data;
• To promote innovation through flexible and risk-proportionate approaches.

The current translation was coordinated by the Executive Council of PLICIB, with scientific review conducted by the Scientific Council of PLICIB and AICIB – Agency for Clinical Research and Biomedical Innovation.

The translated document is available [here]. For more information about ICH, please visit the official website: https://www.ich.org/