The internationally- recognized standard for the design, conduct, recording and reporting of clinical trials involving human subjects. Adherence to the principles of GCP is essential in ensuring ethical standards and scientific quality, while providing public assurance that the rights, safety and well-being of trial subjects are protected. This website focuses on the practical implementation of GCP standards, with an emphasis on training and development.
In 2018, for the first time in over 20 years, the International Council for Harmonization (ICH) Good Clinical Practice (GCP) E6 R2 Guideline was significantly updated. The revisions are intended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results. But, the changes have resounding effects on the conduct of clinical research by sponsors/CR
This website is dedicated to providing resources that can assist companies in reinforcing the core concepts of Good Clinical Practice (GCP) application of GCP principles including ICH GCP E6 R2. Included are a number of training courses, webinars, self-paced learning modules and publications that assist industry professionals in navigating the myriad of changes associated with the ICH revision.