Course – Good Clinical Practice (GCP) Guidelines in Research ICH E6 (R3)

The Good Clinical Practice (GCP) guide is an international standard of ethical and scientific quality applicable to the design, conduct, registration and communication of clinical trials in which human beings participate. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected in accordance with the principles of the Declaration of Helsinki, as well as ensuring the credibility of clinical trial data.

The objective of this ICH GCP guideline is to provide a single standard for the European Union, Japan and the United States, thereby facilitating the mutual acceptance of clinical data by the regulatory authorities of these jurisdictions.

This guide, published in 1996, has been updated to include new approaches and procedures in the development of clinical trials with medicines, consolidating itself as the mandatory quality standard for the performance of MCIs for human use and is currently presented as mandatory compliance by the legislation in this matter (both Spanish and European). LThe latest update, version E6 (R3), came into effect en June 2025 and the new approaches and perspectives of the Guide are included in this editioncourse instruction.

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials of medicinal products for human use includes, among the documents required to assess the suitability of the investigator, that prior training in the principles of good clinical practice must be reflected. 

For this reason, it is considered important to offer training on GCP Standards to researchers or healthcare professionals who are developing ECMs or are interested in participating in an ECM in the future.

(*) The course is aimed at healthcare personnel working in any of the specialized or primary healthcare centers of the SALUD and the Department, as well as members of research groups of the IIS Aragón.