How many core principles are outlined in the ICH-GCP?

The choice of 13 core principles outlined in the International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines is based on the comprehensive framework designed to ensure ethical and scientific quality in the conduct of clinical trials involving human subjects. These principles emphasize the importance of protecting the rights, safety, and well-being of trial participants, as well as ensuring the credibility and accuracy of trial data.

Each of the 13 core principles serves a specific purpose, collectively fostering an environment of safety, respect, and accountability in clinical research. These principles guide researchers and organizations in adhering to established ethical standards, regulatory requirements, and scientific rigor throughout the course of their studies.

By following these principles, investigators and sponsors are able to maintain public trust in clinical research, ensure compliance with regulatory authorities, and facilitate the acceptance of trial results by the scientific community. This framework is essential for promoting consistency and reliability in clinical trials conducted across different regions and countries, contributing to the overall advancement of medical science and public health.