Yogyakarta – Indonesia. Center for Tropical Medicine, Faculty of Medicine, Universitas Gadjah Mada with the support from WHO/TDR has successfully conducted the first batch Regional Course on Good Clinical Practice (GCP) at the Phoenix Hotel, Yogyakarta from September 4 to 6, 2015.
Good Clinical Practice is an international ethical and scientific standard for designing, conducting, analyzing and reporting clinical trials that involve participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well being of trial subjects are protected. It also ensures the credibility of the trial data. This course is dedicated to developing country research and development activities whose researchers are compelled to adhere to GCP in environments that may not be easily conducive to GCP requirements. The module provides an overview of what forces led to the landmark International Conference on Harmonization (ICH) that triggered the GCP through combination of interactive lectures, discussions, practical exercises – small group work, role-plays and preparation/review of records.