Module 4R3 - ICH-GCP(R3) is an updated and comprehensive guide to the elements and principles of the 2025 revision (R3) of the Good Clinical Practice (GCP) quality standards for clinical trials. Module 4R3 on the ICH-GCP(R3) is aligned with current needs and reflects the evolving standards in clinical research. The 4R3 GCP module is relevant to anyone carrying out clinical trials and will be valuable for investigators, nurses, pharmacists, certain members of Ethics Committees and Competent Authorities, clinical trial monitors, staff working in pharmaceutical companies and Contract Research Organizations.
This module is complementary to Modules 1, 2 and 3 of the TRREE Training program. Those modules need to be completed prior to beginning this one.
The purpose of this module is to introduce course participants to key ethical complexities that may arise in the context of clinical trials of biomedical HIV prevention products involving adolescents as participants. This introductory module is primarily intended for those involved in the design and conduct of such trials, such as site-staff, and those involved in the review of protocols such as Research Ethics Committee members.